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Õß§å°“√Õπ“¡—¬‚≈° ©∫—∫ªï §.». 2010

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“√∫—≠Àπâ“ (Page)

Preface

§”π” ....................................................................................................................................................... 1

General considerations

¢âÕæ‘®“√≥“∑—Ë«‰ª .................................................................................................................................... 3

Glossary

ª√–¡«≈§”»—æ∑å ...................................................................................................................................... 7

Part one. Management and infrastructure

à«π∑’Ë 1 °“√∫√‘À“√®—¥°“√ ·≈–‚§√ß √â“ßæ◊Èπ∞“π¢ÕßÕß§å°√. ........................................................... 19

1. Organization and management

Õß§å°√·≈–°“√∫√‘À“√®—¥°“√ ........................................................................................................ 19

2. Quality management system

√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ ................................................................................................... 23

3. Control of documentation

°“√§«∫§ÿ¡‡Õ° “√ ........................................................................................................................ 29

4. Records

∫—π∑÷° ............................................................................................................................................ 29

5. Data-processing equipment

‡§√◊ËÕß¡◊Õ∑’Ë„™â„π°“√ª√–¡«≈º≈¢âÕ¡Ÿ≈ ......................................................................................... 31

6. Personnel

∫ÿ§≈“°√ ......................................................................................................................................... 33

7. Premises

∂“π∑’Ë .......................................................................................................................................... 37

8. Equipment, instruments and other devices

‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ...................................................................................... 41

9. Contracts

°“√∑”¢âÕµ°≈ßµà“ßÊ ..................................................................................................................... 41

Part two. Materials, equipment, instruments and other devices

à«π∑’Ë 2 «— ¥ÿ ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ. ..................................................................... 43

10. Reagents

“√∑”ªØ‘°‘√‘¬“ ............................................................................................................................... 43

11. Reference substances and reference materials

“√¡“µ√∞“π·≈–«— ¥ÿÕâ“ßÕ‘ß ......................................................................................................... 47

12. Calibration, verification of performance and qualification of equipment,

instruments and other devices

°“√ Õ∫‡∑’¬∫ °“√∑«π Õ∫ ¡√√∂π–·≈–°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ

‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ...................................................................................................... 51

13. Traceability

°“√ Õ∫°≈—∫‰¥â ............................................................................................................................. 55

Part three. Working procedures

à«π∑’Ë 3 ¢—ÈπµÕπ°“√ªØ‘∫—µ‘ß“π. .......................................................................................................... 55

14. Incoming samples

µ—«Õ¬à“ß∑’Ë‰¥â√—∫ .............................................................................................................................. 55

15. Analytical worksheet

·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå ................................................................................................ 61

16. Validation of analytical procedures

°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß¢—ÈπµÕπ°“√«‘‡§√“–Àå ................................................................... 67

17. Testing

°“√∑¥ Õ∫ ................................................................................................................................... 69

18. Evaluation of test results

°“√ª√–‡¡‘πº≈°“√∑¥ Õ∫ ........................................................................................................... 71

19. Certificate of analysis

„∫√—∫√Õßº≈°“√«‘‡§√“–Àå ............................................................................................................. 77

20. Retained samples

µ—«Õ¬à“ß∑’Ë‡°Á∫À≈—ß«‘‡§√“–Àå·≈â«‡ √Á® ............................................................................................. 77

Part four. Safety

à«π∑’Ë 4 §«“¡ª≈Õ¥¿—¬. ...................................................................................................................... 79

21. General rules

À≈—°‡°≥±å∑—Ë«‰ª ........................................................................................................................... 79

References ............................................................................................................................................ 82

Appendix .............................................................................................................................................. 86

Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory ........... 86

Àπâ“ (Page)

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§”π”

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©∫—∫„À¡à WHO good practices for pharmaceutical quality control laboratories (2010) ´÷Ëßª√“°Ø„π

WHO Technical Report Series, No. 957, 2010 Annex 1 ‡æ◊ËÕ‡ªìπ·π«∑“ßªØ‘∫—µ‘·°àÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡

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new-inside-book copy21 1/7/11, 7:371

WHO good practices for pharmaceuticalquality control laboratories

2

General considerations

The WHO Expert Committee on Specifications for Pharmaceutical Products adopted in1999 the guidelines entitled WHO Good practices for national pharmaceutical controllaboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902,2002. As the other guidelines related to laboratory quality assurance have been updated andsubsequent inspections for the compliance with the guidelines on good practices for nationalpharmaceutical control laboratories indicated that some sections were in need of improvementand clarification, it was considered necessary to prepare a revised text.

These guidelines provide advice on the quality management system within which theanalysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products shouldbe performed to demonstrate that reliable results are obtained.

Compliance with the recommendations provided in these guidelines will help promoteinternational harmonization of laboratory practices and will facilitate cooperation among laboratoriesand mutual recognition of results.

Special attention should be given to ensure the correct and efficient functioning of thelaboratory. Planning and future budgets should ensure that the necessary resources are availableinter alia for the maintenance of the laboratory, as well as for an appropriate infrastructure andenergy supply. Means and procedures should be in place (in case of possible supplyproblems)to ensure that the laboratory can continue its activities.

These guidelines are applicable to any pharmaceutical quality control laboratory, be itnational, commercial or nongovernmental. However, they do not include guidance for thoselaboratories involved in the testing of biological products, e.g. vaccines and blood products.Separate guidance for such laboratories is available.

These guidelines are consistent with the requirements of the WHO guidelines for goodmanufacturing practices (1) and with the requirements of the International Standard ISO/IEC 17025:2005 (2), and provide detailed guidance for laboratories performing quality control of medicines.The guidance specific to microbiology laboratories can be found in the draft workingdocument WHO guideline on good practices for pharmaceutical microbiology laboratories(reference QAS/09.297).

The good practice outlined below is to be considered as a general guide and it maybe adapted to meet individual needs provided that an equivalent level of quality assurance isachieved. The notes given provide clarification of the text or examples; they do not containrequirements which should be fulfilled to comply with these guidelines.


3À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

¢âÕæ‘®“√≥“∑—Ë«‰ª

§≥–°√√¡°“√ºŸâ‡™’Ë¬«™“≠¢ÕßÕß§å°“√Õπ“¡—¬‚≈°¥â“π¢âÕ°”Àπ¥∑“ß‡¿ —™¿—≥±å ¡’¡µ‘√—∫√ÕßÀ≈—°

ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡‡¿ —™¿—≥±å√–¥—∫™“µ‘¢ÕßÕß§å°“√Õπ“¡—¬‚≈° (WHO Good practices

for national pharmaceutical control laboratories) „πªï 1999 ´÷Ëß‰¥â√—∫°“√µ’æ‘¡æå„π¿“§ºπ«° 3 ¢Õß

WHO Technical Report Series No. 902, 2002 ¢≥–∑’Ë·π«∑“ßªØ‘∫—µ‘Õ◊ËπÊ ∑’Ë‡°’Ë¬«¢âÕß°—∫°“√ª√–°—π

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ªØ‘∫—µ‘ ∫àß™’È«à“§«√ª√—∫ª√ÿß·°â‰¢‡π◊ÈÕÀ“∫“ßµÕπ·≈–∑”„Àâ™—¥‡®π¢÷Èπ ®÷ß®”‡ªìπµâÕß®—¥∑”©∫—∫ª√—∫ª√ÿß„À¡à¢÷Èπ

·π«∑“ßªØ‘∫—µ‘π’È„Àâ§”·π–π”‡√◊ËÕß√–∫∫°“√®—¥°“√¥â“π§ÿ≥¿“æ „π°“√«‘‡§√“–ÀåÀ“ª√‘¡“≥ “√

ÕÕ°ƒ∑∏‘Ï∑“ß‡¿ —™°√√¡ (µ—«¬“ ”§—≠) “√ª√ÿß·µàß¬“ ·≈–‡¿ —™¿—≥±å ‡æ◊ËÕ„Àâ‰¥âº≈°“√∑¥ Õ∫∑’Ë‡™◊ËÕ∂◊Õ‰¥â

°“√ªØ‘∫—µ‘µ“¡§”·π–π”∑’Ë√–∫ÿ„π·π«∑“ßªØ‘∫—µ‘‡À≈à“π’È ®–™à«¬ àß‡ √‘¡∑—°…–°“√∑”ß“π„πÀâÕßªØ‘∫—µ‘°“√

¢Õßª√–‡∑»µà“ßÊ „Àâ‡ªìπ‰ª„π∑‘»∑“ß‡¥’¬«°—π ·≈– –¥«°µàÕ§«“¡√à«¡¡◊Õ√–À«à“ßÀâÕßªØ‘∫—µ‘°“√·≈–°“√¬Õ¡√—∫

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∂Ÿ°µâÕß·≈–¡’ª√– ‘∑∏‘¿“æ §«√¡’°“√«“ß·ºπ·≈–®—¥ √√ß∫ª√–¡“≥≈à«ßÀπâ“ ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“¡’∑√—æ¬“°√∑’Ë®”‡ªìπ

‡æ’¬ßæÕ ”À√—∫∫”√ÿß√—°…“ÀâÕßªØ‘∫—µ‘°“√ ·≈–‡æ◊ËÕ„Àâ¡’‚§√ß √â“ßæ◊Èπ∞“π·≈–æ≈—ßß“π‡æ’¬ßæÕ §«√¡’«‘∏’°“√

·≈–°√–∫«π°“√∑’Ë√Õß√—∫ („π°√≥’∑’ËÕ“®¡’ªí≠À“‡°’Ë¬«°—∫°“√®—¥À“) ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“ÀâÕßªØ‘∫—µ‘°“√ “¡“√∂

¥”‡π‘π°‘®°√√¡µàÕ‰ª‰¥â

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·µàÀâÕßªØ‘∫—µ‘°“√√–¥—∫™“µ‘ ÀâÕßªØ‘∫—µ‘°“√‡™‘ßæ“≥‘™¬å ·≈–ÀâÕßªØ‘∫—µ‘°“√¢ÕßÕß§å°√πÕ°¿“§√—∞Õ◊ËπÊ ¬°‡«âπ

ÀâÕßªØ‘∫—µ‘°“√∑’Ë‡°’Ë¬«¢âÕß°—∫°“√∑¥ Õ∫º≈‘µ¿—≥±å∑“ß™’«¿“æ ‡™àπ «—§´’π º≈‘µ¿—≥±å‡≈◊Õ¥ ·≈–º≈‘µ¿—≥±å∑“ß

™’«¿“æÕ◊ËπÊ ´÷Ëß®–¡’·π«∑“ßªØ‘∫—µ‘‡©æ“–¥â“π∑’Ë·µ°µà“ßÕÕ°‰ª

·π«∑“ßªØ‘∫—µ‘‡À≈à“π’È Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥¢ÕßÀ≈—°ªØ‘∫—µ‘∑’Ë¥’„π°“√º≈‘µ¢ÕßÕß§å°“√Õπ“¡—¬‚≈°

WHO guidelines for good manufacturing practices (1) ·≈– Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥¢Õß ISO/IEC 17025:2005

(2) ·≈–‰¥â√–∫ÿ√“¬≈–‡Õ’¬¥¢Õß·π«∑“ßªØ‘∫—µ‘ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ¬“‰«â¥â«¬ À≈—°ªØ‘∫—µ‘∑’Ë¥’

”À√—∫ÀâÕßªØ‘∫—µ‘°“√∑“ß®ÿ≈™’««‘∑¬“¢Õß‡¿ —™¿—≥±å “¡“√∂¥Ÿ‰¥â„π‡Õ° “√√à“ß¢ÕßÕß§å°“√Õπ“¡—¬‚≈° (WHO

guideline on good practices for pharmaceutical microbiology laboratories (reference QAS/09.297))

À≈—°ªØ‘∫—µ‘∑’Ë¥’∑’Ë®–°≈à“«∂÷ßµàÕ‰ªπ’È ‰¥â√—∫°“√æ‘®“√≥“„Àâ‡ªìπ·π«∑“ßªØ‘∫—µ‘∑—Ë«‰ª·≈–Õ“®π”¡“ª√—∫„™â

‡æ◊ËÕµÕ∫ πÕßµàÕ§«“¡µâÕß°“√¢Õß·µà≈–ÀâÕßªØ‘∫—µ‘°“√ Õ—π®–π”‰ª Ÿà°“√ª√–°—π§ÿ≥¿“æ„π√–¥—∫‡¥’¬«°—π ”À√—∫

¢âÕ§«“¡„πÀ¡“¬‡Àµÿ®–‡ªìπ à«π¢¬“¬„Àâ™—¥‡®π¬‘Ëß¢÷Èπ À√◊Õ‡ªìπ°“√¬°µ—«Õ¬à“ß ‚¥¬‰¡à¡’ à«π¢Õß¢âÕ°”Àπ¥„¥Ê

´÷Ëß§«√Õ¬Ÿà„π·π«∑“ßªØ‘∫—µ‘Õ¬à“ß§√∫∂â«π·≈â«



4

Pharmaceutical quality control testing is usually a matter of repetitive testing of samplesof APIs or of a limited number of pharmaceutical products, whereas national quality controllaboratories have to be able to deal with a much wider range of pharmaceutical substancesand products and, therefore, have to apply a wider variety of test methods. Specificrecommendations for national pharmaceutical quality control laboratories are addressed in thefollowing text. Particular consideration is given to countries with limited resources wishingto establish a governmental pharmaceutical quality control laboratory, having recently done so,or which are planning to modernize an existing laboratory.

Quality control laboratories may perform some or all quality control activities, e.g. sam-pling, testing of APIs, excipients, packaging materials and/or pharmaceutical products, stabilitytesting, testing against specifications and investigative testing.

For the quality of a medicine sample to be correctly assessed:

- The submission of a sample of an API, excipient or pharmaceutical product or asuspected counterfeit material to the laboratory, selected in accordance with national requirements,should be accompanied by a statement of the reason why the analysis has been requested.

- The analysis should be correctly planned and meticulously executed.

- The results should be competently evaluated to determine whether the sample complieswith the specifications or other relevant criteria.

National pharmaceutical quality control laboratories

The government, normally through the national medicines regulatory authority (NMRA),may establish and maintain a pharmaceutical quality control laboratory to carry out the requiredtests and assays to verify that APIs, excipients and pharmaceutical products meet theprescribed specifications. Large countries may require several pharmaceutical quality controllaboratories which conform to national legislation, and appropriate arrangements should, therefore,be in place to monitor their compliance with a quality management system. Throughout theprocess of marketing authorization and postmarketing surveillance, the laboratory or laboratorieswork closely with the NMRA.

A national pharmaceutical quality control laboratory provides effective support for anNMRA acting together with its inspection services. The analytical results obtained shouldaccurately describe the properties of the samples assessed, permitting correct conclusions to bedrawn about the quality of the samples of medicines analysed, and also serving as an adequatebasis for any subsequent administrative regulations and legal action.


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µ√«®«‘‡§√“–Àå

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ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å√–¥—∫™“µ‘

‚¥¬∑—Ë«‰ªÀπà«¬ß“π°”°—∫¥Ÿ·≈¥â“π¬“√–¥—∫™“µ‘ À√◊Õ National medicines regulatory authority

(NMRA) ‡ªìπÀπà«¬ß“π¢Õß√—∞∫“≈ ∑’ËÕ“®®—¥µ—Èß·≈–§ß‰«â´÷ËßÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å‡æ◊ËÕ

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∑’Ë¡’°“√µ√«®æ‘π‘® (inspection) º≈«‘‡§√“–Àå∑’Ë‰¥â√—∫§«√∫àß∫Õ°§ÿ≥ ¡∫—µ‘¢Õßµ—«Õ¬à“ß∑’Ë∂Ÿ°ª√–‡¡‘π‰¥âÕ¬à“ß

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6

National pharmaceutical quality control laboratories usually encompass essentially two typesof activity:

- compliance testing of APIs, pharmaceutical excipients and pharmaceutical productsemploying çofficialé methods including pharmacopoeial methods, validated analytical proceduresprovided by the manufacturer and approved by the relevant government authority for marketingauthorization or validated analytical procedures developed by the laboratory; and

- investigative testing of suspicious, illegal, counterfeit substances or products,submitted for examination by medicine inspectors, customs or police.

To ensure patient safety, the role of the national pharmaceutical quality control laboratoryshould be defined in the general pharmaceutical legislation of the country in such a way that theresults provided by it can, if necessary, lead to enforcement of the law and legal action.

Glosssary

The definitions given below apply to the terms as used in these guidelines. They mayhave different meanings in other contexts.

acceptance criterion for an analytical result

Predefined and documented indicators by which a result is considered to be within thelimit(s) or to exceed the limit(s) indicated in the specification.

accuracy

The degree of agreement of test results with the true value or the closeness of theresults obtained by the procedure to the true value (1).

Note: It is normally established on samples of the material to be examined thathave been prepared to quantitative accuracy. Accuracy should be established across the specifiedrange of the analytical procedure. It is generally acceptable to use a çspikedé placebo whichcontains a known quantity or concentration of a reference substance.

active pharmaceutical ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture ofa pharmaceutical dosage form and that, when so used, becomes an active ingredient of thatpharmaceutical dosage form. Such substances are intended to furnish pharmacological activityor other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or toaffect the structure and function of the body (1).


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- ¥”‡π‘π°“√∑¥ Õ∫µ—«¬“ ”§—≠ “√ª√ÿß·µàß¬“ ·≈– ‡¿ —™¿—≥±å µ“¡«‘∏’∑’Ë‡ªìπ¡“µ√∞“πµ“¡

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µ√«® Õ∫§«“¡∂Ÿ°µâÕß·≈â« ·≈–

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‡°≥±å°“√¬Õ¡√—∫ ”À√—∫º≈«‘‡§√“–Àå

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ºà“π‡°≥±å¡“µ√∞“πµ“¡¢âÕ°”Àπ¥

§«“¡·¡àπ

§à“· ¥ß§«“¡„°≈â‡§’¬ß√–À«à“ß º≈°“√∑¥ Õ∫·≈–§à“®√‘ß

À¡“¬‡Àµÿ: ‚¥¬ª°µ‘®–°”Àπ¥§à“π’È„πµ—«Õ¬à“ß∑’Ë®–µ√«® Õ∫À“§«“¡∂Ÿ°µâÕß‡™‘ßª√‘¡“≥ §à“§«“¡·¡àπ

§«√°”Àπ¥„Àâ§√Õ∫§≈ÿ¡™à«ß¢Õß°“√µ√«®«‘‡§√“–Àå ”À√—∫«‘∏’∑’Ë¬Õ¡√—∫‚¥¬∑—Ë«‰ª §◊Õ «‘∏’ spiked placebo

´÷Ëß‡ªìπ°“√‡µ‘¡ “√Õâ“ßÕ‘ß∑’Ë√Ÿâª√‘¡“≥À√◊Õ§«“¡‡¢â¡¢âπ≈ß‰ª„π placebo

“√ÕÕ°ƒ∑∏‘Ï∑“ß‡¿ —™°√√¡ (µ—«¬“ ”§—≠)

“√„¥Ê À√◊Õ à«πº ¡¢Õß “√„¥Ê ∑’Ë¡ÿàßÀ¡“¬„Àâ„™â„π°“√º≈‘µ‡¿ —™¿—≥±å ”‡√Á®√Ÿª ·≈–‡¡◊ËÕπ”¡“„™â

„π°“√º≈‘µ¬“®–∑”Àπâ“∑’Ë‡ªìπ “√ÕÕ°ƒ∑∏‘Ï¢Õß‡¿ —™¿—≥±å ”‡√Á®√Ÿªπ—ÈπÊ “√¥—ß°≈à“«‡ªìπ “√∑’Ë„™â‡æ◊ËÕ§«“¡

¡ÿàßÀ¡“¬„Àâ‰¥âƒ∑∏‘Ï∑“ß‡¿ —™«‘∑¬“À√◊Õ¡’º≈‚¥¬µ√ßÕ◊ËπÊ µàÕ°“√«‘π‘®©—¬ °“√√–ß—∫ °“√∫√√‡∑“ °“√∫”∫—¥√—°…“

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8

analytical test report

An analytical test report usually includes a description of the test procedure(s)employed, results of the analysis, discussion and conclusions and/or recommendations for oneor more samples submitted for testing (see Part three, sections 18.7-18.11).

analytical worksheet

A printed form, an analytical workbook or electronic means (e-records) for recordinginformation about the sample, as well as reagents and solvents used, test procedure applied,calculations made, results and any other relevant information or comments (see Part three,section 15).

batch (or lot)

A defined quantity of starting material, packaging material or product processed ina single process or series of processes so that it is expected to be homogeneous. It maysometimes be necessary to divide a batch into a number of sub-batches which are laterbrought together to form a final homogeneous batch. In the case of terminal sterilization the batchsize is determined by the capacity of the autoclave. In continuous manufacture the batchshould correspond to a defined fraction of the production, characterized by its intendedhomogeneity. The batch size can be defined either as a fixed quantity or as the amount producedin a fixed time interval (1).

batch number (or lot number)

A distinctive combination of numbers and/or letters which uniquely identifies a batch onthe labels, its batch records and corresponding certificates of analysis (1).

calibration

The set of operations that establish, under specified conditions, the relationshipbetween values indicated by an instrument or system for measuring (especially weighing),recording and controlling, or the values represented by a material measure, and the correspondingknown values of a reference standard. Limits for acceptance of the results of measuring shouldbe established (1).

certificate of analysis

The list of test procedures applied to a particular sample with the results obtained and theacceptance criteria applied. It indicates whether or not the sample complies with the specification (3).

certified reference material

Reference material, characterized by a metrologically valid procedure for one or morespecified properties, accompanied by a certificate that provides the value of the specified property,its associated uncertainty and a statement of metrological traceability (4).


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(¥Ÿ à«π∑’Ë 3 ¢âÕ 18.7-18.11)

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À¡âÕπ÷Ëß‰ÕπÈ”§«“¡¥—π Ÿß (autoclave) „π°√≥’¢Õß°√–∫«π°“√º≈‘µ·∫∫µàÕ‡π◊ËÕß √ÿàπ∑’Ëº≈‘µ§«√ Õ¥§≈âÕß°—∫

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À√◊Õ‡ªìπ®”π«π∑’Ëº≈‘µ„π™à«ß‡«≈“∑’Ë°”Àπ¥ (1)

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°“√ Õ∫‡∑’¬∫

°“√¥”‡π‘π°“√µà“ßÊ ¿“¬„µâ ¿“«–∑’Ë°”Àπ¥ ‡æ◊ËÕÀ“§«“¡ —¡æ—π∏å√–À«à“ß§à“∑’Ë∑√“∫®“° “√¡“µ√∞“π

Õâ“ßÕ‘ß°—∫§à“∑’Ë‰¥â®“°‡§√◊ËÕß¡◊Õ À√◊Õ®“°√–∫∫°“√«—¥ (‚¥¬‡©æ“–Õ¬à“ß¬‘Ëß°“√™—ËßπÈ”Àπ—°) §à“∑’Ë‰¥â®“°°“√∫—π∑÷°

·≈–°“√§«∫§ÿ¡ À√◊Õ§à“∑’Ë‰¥â®“°°“√«—¥ ‘Ëß¢Õß ‚¥¬°”Àπ¥¢Õ∫‡¢µ„π°“√¬Õ¡√—∫º≈®“°°“√«—¥¥â«¬ (1)

„∫√—∫√Õßº≈°“√«‘‡§√“–Àå

√“¬°“√∑’Ë· ¥ß«‘∏’°“√∑¥ Õ∫µ—«Õ¬à“ß æ√âÕ¡º≈«‘‡§√“–Àå∑’Ë‰¥â ·≈–‡°≥±å°“√¬Õ¡√—∫ ´÷Ëß∫àß™’È«à“

µ—«Õ¬à“ßπ—ÈπÊ Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥¡“µ√∞“πÀ√◊Õ‰¡à (3)

«— ¥ÿÕâ“ßÕ‘ß√—∫√Õß

«— ¥ÿÕâ“ßÕ‘ß∑’Ë¡’°“√°”Àπ¥§ÿ≥ ¡∫—µ‘‡©æ“–Õ¬à“ßÀπ÷ËßÀ√◊ÕÀ≈“¬Õ¬à“ß‰«â ‚¥¬¢—ÈπµÕπ∑“ß¡“µ√«‘∑¬“

´÷Ëß¡’„∫√—∫√Õß√–∫ÿ§à“¢Õß§ÿ≥ ¡∫—µ‘π—ÈπÊ ‰«â æ√âÕ¡§à“§«“¡‰¡à·πàπÕπ ·≈–¡’¢âÕ§«“¡∑’Ë√–∫ÿ«à“ “¡“√∂ Õ∫°≈—∫‰¥â

„π∑“ß¡“µ√«‘∑¬“ (4)



10

compliance testing

Analysis of active pharmaceutical ingredients (APIs), pharmaceutical excipients,packaging material or pharmaceutical products according to the requirements of a pharmacopoeialmonograph or a specification in an approved marketing authorization.

control sample

A sample used for testing the continued accuracy and precision of the procedure. It shouldhave a matrix similar to that of the samples to be analysed. It has an assigned value withits associated uncertainty.

design qualification (DQ)

Documented collection of activities that define the functional and operational specificationsof the instrument and criteria for selection of the vendor, based on the intended purpose of theinstrument.

Note: Selection and purchase of a new instrument should follow a consciousdecision process, based on the needs of the technical management. When designing a newlaboratory facility, the design specification and the requirements for services should be agreedbetween the management team and the agreed suppliers and documented.

good manufacturing practice(s) (GMP)

That part of quality assurance which ensures that pharmaceutical products areconsistently produced and controlled to the quality standards appropriate to their intended use andas required by the marketing authorization (1).

installation qualification (IQ)

The performance of tests to ensure that the analytical equipment used in a laboratoryis correctly installed and operates in accordance with established specifications.

management review

A formal, documented review of the key performance indicators of a quality managementsystem performed by top management.

manufacturer

A company that carries out operations such as production, packaging, testing, repackaging,labelling and/or relabelling of pharmaceuticals (1).


11À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

°“√∑¥ Õ∫µ“¡«‘∏’ (compliance testing)

°“√µ√«®«‘‡§√“–Àåµ—«¬“ ”§—≠ “√ª√ÿß·µàß¬“ «— ¥ÿ ”À√—∫°“√∫√√®ÿ À√◊Õ ‡¿ —™¿—≥±å µ“¡¢âÕ°”Àπ¥

¡“µ√∞“π¢Õßµ”√“¬“À√◊Õ¢Õß∑–‡∫’¬πµ”√—∫¬“∑’Ëºà“π°“√√—∫√Õß·≈â«

µ—«Õ¬à“ß‡æ◊ËÕ°“√§«∫§ÿ¡

µ—«Õ¬à“ß∑’Ë„™â ”À√—∫∑¥ Õ∫§«“¡·¡àπ·≈–§«“¡‡∑’Ë¬ßÕ¬à“ßµàÕ‡π◊ËÕß¢Õß¢—ÈπµÕπ°“√∑¥ Õ∫ ÷Ëß§«√®–¡’

‡π◊ÈÕ “√§≈â“¬°—∫µ—«Õ¬à“ß∑’Ë®–«‘‡§√“–Àå µ—«Õ¬à“ß§«∫§ÿ¡π’È®–∑√“∫§à“∑’Ë°”Àπ¥‰«âæ√âÕ¡°—∫§à“§«“¡‰¡à·πàπÕπ

∑’Ë‡°’Ë¬«¢âÕß

design qualification (DQ)

°“√√«∫√«¡°‘®°√√¡·≈–®—¥∑”‡ªìπ‡Õ° “√∑’Ë√–∫ÿª√–‚¬™πå„™â Õ¬·≈–§ÿ≥≈—°…≥–°“√∑”ß“π¢Õß‡§√◊ËÕß¡◊Õ

·≈–‡°≥±å°“√§—¥‡≈◊Õ°ºŸâ®”Àπà“¬ ∫πæ◊Èπ∞“π¢Õß®ÿ¥¡ÿàßÀ¡“¬∑’Ë√–∫ÿ‰«â°—∫‡§√◊ËÕß¡◊Õπ—ÈπÊ

À¡“¬‡Àµÿ: °“√§—¥‡≈◊Õ°·≈–®—¥´◊ÈÕ‡§√◊ËÕß¡◊Õ„À¡à§«√®–¡’°√–∫«π°“√µ—¥ ‘π„®∑’Ë√Õ∫§Õ∫‚¥¬¢÷ÈπÕ¬Ÿà°—∫

§«“¡µâÕß°“√¢ÕßΩÉ“¬®—¥°“√∑“ß‡∑§π‘§ ‡¡◊ËÕ¡’°“√ÕÕ°·∫∫ÀâÕßªØ‘∫—µ‘°“√„À¡à ‡æ◊ËÕÕ”π«¬§«“¡ –¥«°

°≈ÿà¡°“√®—¥°“√·≈–ºŸâ®”Àπà“¬„Àâ §«√®–µ°≈ß°—π‡°’Ë¬«°—∫√“¬≈–‡Õ’¬¥ÀâÕßªØ‘∫—µ‘°“√∑’ËÕÕ°·∫∫¢÷Èπ·≈–

§«“¡µâÕß°“√„π°“√√—∫∫√‘°“√ ‚¥¬¡’°“√®—¥∑”‡ªìπ‡Õ° “√

·π«ªØ‘∫—µ‘∑’Ë¥’„π°“√º≈‘µ (GMP)

à«π¢Õß°“√ª√–°—π§ÿ≥¿“æ ÷Ëß√—∫√Õß«à“‡¿ —™¿—≥±åºà“π°√–∫«π°“√º≈‘µ§ß∑’Ë ¡Ë”‡ ¡Õ·≈–°“√

§«∫§ÿ¡§ÿ≥¿“æµ“¡¡“µ√∞“π∑’Ë‡À¡“– ¡ µ√ßµ“¡«—µ∂ÿª√– ß§å„π°“√π”‰ª„™â µ“¡∑’Ë‰¥â°”Àπ¥‰«â„π∑–‡∫’¬π

µ”√—∫∑’Ë‰¥â√—∫Õπÿ≠“µ (1)

installation qualification (IQ)

°“√∑¥ Õ∫µà“ßÊ ‡æ◊ËÕ¬◊π¬—π«à“‡§√◊ËÕß¡◊Õ°“√«‘‡§√“–Àå∑’Ë„™â„πÀâÕßªØ‘∫—µ‘°“√‰¥â√—∫°“√µ‘¥µ—Èß·≈–∑”ß“π

Õ¬à“ß∂Ÿ°µâÕß Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥√“¬≈–‡Õ’¬¥∑’Ë®—¥∑”¢÷Èπ

°“√∑∫∑«π°“√∫√‘À“√®—¥°“√

°“√∑∫∑«π°“√∫√‘À“√®—¥°“√‡ªìπµ—«∫àß™’È∂÷ß§ÿ≥¿“æ¢Õß√–∫∫∫√‘À“√®—¥°“√ ÷ËßµâÕß¡’°“√®—¥∑”‡ªìπ

‡Õ° “√·≈–¥”‡π‘π°“√‚¥¬ºŸâ∫√‘À“√ Ÿß ÿ¥

ºŸâº≈‘µ

Àπà«¬ß“π∑’Ë¥”‡π‘π°“√‡°’Ë¬«°—∫‡¿ —™¿—≥±å ‰¥â·°à °“√º≈‘µ °“√∫√√®ÿ °“√∑¥ Õ∫ °“√∫√√®ÿ„À¡à

°“√µ‘¥©≈“° ·≈–/À√◊Õ °“√µ‘¥©≈“°„À¡à (1)



12

marketing authorization (product licence, registration certificate)

A legal document issued by the competent medicines regulatory authority that authorizesthe marketing or free distribution of a pharmaceutical product in the respective country afterevaluation for safety, efficacy and quality. In terms of quality it establishes inter alia the detailedcomposition and formulation of the pharmaceutical product and the quality requirements for theproduct and its ingredients. It also includes details of packaging, labelling, storage conditions,shelf-life and approved conditions of use.

measurement uncertainty

Non-negative parameter characterizing the dispersion of quantity values being attributedto a measurand (analyte), based on the information used (4).

metrological traceability

Property of a measurement result whereby the result can be related to a reference througha documented, unbroken chain of calibrations, each contributing to the measurement uncertainty (4).

operational qualification (OQ)

Documented verification that the analytical equipment performs as intended over allanticipated operating ranges.

out-of-specification (OOS) result

All test results that fall outside the specifications or acceptance criteria established inproduct dossiers, drug master files, pharmacopoeias or by the manufacturer (5).

performance qualification (PQ)

Documented verification that the analytical equipment operates consistently and givesreproducibility within the defined specifications and parameters for prolonged periods.

pharmaceutical excipient

A substance, other than the active pharmaceutical ingredient (API), which has beenappropriately evaluated for safety and is included in a medicines delivery system to:

- aid in the processing of the medicines delivery system during its manufacture;

- protect, support or enhance stability, bioavailability or patient acceptability;

- assist in pharmaceutical product identification; or

- enhance any other attribute of the overall safety and effectiveness of the medicineduring its storage or use (6, 7).


13À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

°“√Õπÿ≠“µ∑“ß°“√µ≈“¥ („∫Õπÿ≠“µº≈‘µ¿—≥±å Àπ—ß ◊Õ√—∫√Õß°“√¢÷Èπ∑–‡∫’¬π)

‡Õ° “√∑’Ë∂Ÿ°µâÕßµ“¡°ÆÀ¡“¬∑’ËÕÕ°‚¥¬ºŸâ¡’Õ”π“®„π°“√§«∫§ÿ¡¬“ ´÷ËßÕπÿ≠“µ„Àâ¡’°“√®—¥®”Àπà“¬

‡¿ —™¿—≥±å„πª√–‡∑»π—ÈπÊ À≈—ß®“°∑’Ë‰¥âª√–‡¡‘π¥â“π§«“¡ª≈Õ¥¿—¬ ª√– ‘∑∏‘¿“æ ·≈–§ÿ≥¿“æ „π·ßà¢Õß

§ÿ≥¿“æ ‡Àπ◊Õ ‘ËßÕ◊Ëπ„¥ §◊Õ √“¬≈–‡Õ’¬¥¢Õß à«πª√–°Õ∫·≈– Ÿµ√µ”√—∫¢Õß‡¿ —™¿—≥±å·≈–¢âÕ°”Àπ¥‡°’Ë¬«°—∫

§ÿ≥¿“æ¢Õßº≈‘µ¿—≥±å·≈– à«πª√–°Õ∫ ¬—ß√«¡∂÷ß√“¬≈–‡Õ’¬¥¢Õß°“√∫√√®ÿ °“√µ‘¥©≈“° ¿“«–°“√®—¥‡°Á∫

Õ“¬ÿ°“√„™â ·≈–‡ß◊ËÕπ‰¢°“√„™â∑’Ëµ√«® Õ∫·≈â«

§«“¡‰¡à·πàπÕπ¢Õß°“√«—¥

non-negative parameter ∫àß∫Õ°≈—°…≥–°“√°√–®“¬¢Õß§à“‡™‘ßª√‘¡“≥ ÷Ëß‡ªìπ§ÿ≥ ¡∫—µ‘¢Õß ‘Ëß∑’Ë

∂Ÿ°«—¥‚¥¬¢÷ÈπÕ¬Ÿà°—∫¢âÕ¡Ÿ≈∑’Ë„™â (4)

°“√ Õ∫°≈—∫‰¥â∑“ß¡“µ√«‘∑¬“

§ÿ≥ ¡∫—µ‘¢Õßº≈°“√«—¥ ‚¥¬∑’Ëº≈°“√«—¥¡’§«“¡ —¡æ—π∏å°—∫¡“µ√∞“π ºà“π∑“ß‡Õ° “√°“√ Õ∫‡∑’¬∫

∑’Ë¡’§«“¡µàÕ‡π◊ËÕß°—π‡ªìπ≈Ÿ°‚´à‰¡à¢“¥µÕπ ·≈–· ¥ß§à“§«“¡‰¡à·πàπÕπ¢Õß°“√«—¥ (4)

operational qualification (OQ)

°“√∑«π Õ∫·≈–®—¥∑”‡Õ° “√‡æ◊ËÕ· ¥ß«à“ ‡§√◊ËÕß¡◊Õ°“√«‘‡§√“–Àå “¡“√∂„™âß“π‰¥â„π¢Õ∫‡¢µ∑’Ë

§“¥°“√≥å‰«â

º≈°“√∑¥ Õ∫∑’Ë‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥

º≈°“√∑¥ Õ∫∑’Ë‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥‡©æ“–À√◊Õ‰¡à‡ªìπ‰ªµ“¡‡°≥±å°“√¬Õ¡√—∫ ∑’Ë°”Àπ¥‰«â„π

product dossier, drug master file , µ”√“¬“ À√◊Õ‚¥¬ºŸâº≈‘µ (5)

performance qualification (PQ)

°“√∑«π Õ∫·≈–®—¥∑”‡Õ° “√‡æ◊ËÕ· ¥ß«à“‡§√◊ËÕß¡◊Õ°“√«‘‡§√“–Àå “¡“√∂∑”ß“πÕ¬à“ß ¡Ë”‡ ¡Õ

·≈– “¡“√∂∑”´È” (reproducibility) ¿“¬„µâ¢âÕ°”Àπ¥·≈–æ“√“¡‘‡µÕ√å „π™à«ß‡«≈“∑’Ë¬“«π“π‰¥â

“√ª√ÿß·µàß¬“

“√„¥Ê ¬°‡«âπ “√ÕÕ°ƒ∑∏‘Ï∑“ß‡¿ —™°√√¡ (µ—«¬“ ”§—≠) ´÷Ëßºà“π°“√ª√–‡¡‘π¥â“π§«“¡ª≈Õ¥¿—¬

Õ¬à“ß‡À¡“– ¡·≈–„™â‡ªìπ “√ àßºà“πµ—«¬“ÕÕ°ƒ∑∏‘Ï„π√à“ß°“¬‡æ◊ËÕ

- ™à«¬„π¢∫«π°“√ àßºà“πµ—«¬“∑’Ë„™â„π√–À«à“ßº≈‘µ¬“

- ªÑÕß°—π π—∫ πÿπ À√◊Õ‡æ‘Ë¡§«“¡§ß ¿“æ ™’«ª√– ‘∑∏‘º≈ À√◊Õ°“√¬Õ¡√—∫¢ÕßºŸâªÉ«¬

- ™à«¬„π°“√®”·π°„Àâ‡ÀÁπ§«“¡·µ°µà“ß¢Õß‡¿ —™¿—≥±å À√◊Õ

- ‡ √‘¡§ÿ≥ ¡∫—µ‘‚¥¬√«¡¥â“π§«“¡ª≈Õ¥¿—¬·≈–ª√– ‘∑∏‘º≈¢Õß¬“√–À«à“ß°“√®—¥‡°Á∫À√◊Õ°“√„™â¬“

(6 ,7)



14

pharmaceutical product

Any material or product intended for human or veterinary use, presented in itsfinished dosage form or as a starting material for use in such a dosage form, which is subjectto control by pharmaceutical legislation in the exporting state and/or the importing state (1).

precision

The degree of agreement among individual results when the procedure is appliedrepeatedly to multiple samplings of a homogeneous sample. Precision, usually expressed asrelative standard deviation, may be considered at three levels: repeatability (precision under thesame operating conditions over a short period of time), intermediate precision (within laboratoryvariations - different days, different analysts or different equipment) and reproducibility(precision between laboratories).

primary reference substance (or standard)

A substance that is widely acknowledged to possess the appropriate qualities withina specified context, and whose assigned content is accepted without requiring comparisonwith another chemical substance (8).

Note: Pharmacopoeial chemical reference substances are considered to be primaryreference substances. In the absence of a pharmacopoeial reference substance, a manufacturershould establish a primary reference substance.

qualification of equipment

Action of proving and documenting that any analytical equipment complies with therequired specifications and performs suitably for its intended purpose (see Part two, section 12).

quality control

All measures taken, including the setting of specifications, sampling, testing andanalytical clearance, to ensure that raw materials, intermediates, packaging materials andfinished pharmaceutical products conform with established specifications for identity, strength,purity and other characteristics.

quality management system

An appropriate infrastructure, encompassing the organizational structure, procedures,processes and resources, and systematic actions necessary to ensure adequate confidence thata product or service will satisfy given requirements for quality (see Part one, section 2).

quality manager

A member of staff who has a defined responsibility and authority for ensuring thatthe management system related to quality is implemented and followed at all times (see Part one,section 1.3(j)).


15À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

‡¿ —™¿—≥±å

«— ¥ÿÀ√◊Õº≈‘µ¿—≥±å„¥Ê ∑’Ë¡’¢âÕ∫àß„™â„π¡πÿ…¬åÀ√◊Õ —µ«å ´÷Ëßπ”‡ πÕ„π√Ÿª·∫∫¬“ ”‡√Á®√ŸªÀ√◊Õ‡ªìπ

“√µ—Èßµâπ ”À√—∫°“√º≈‘µ¬“ ”‡√Á®√Ÿª ´÷Ëß¡’°“√§«∫§ÿ¡¿“¬„µâ°ÆÀ¡“¬∑’Ë„™â°—∫‡¿ —™¿—≥±å∑—Èß‡æ◊ËÕ°“√ àßÕÕ°

·≈–/À√◊Õ°“√π”‡¢â“ (1)

§«“¡‡∑’Ë¬ß

√–¥—∫¢Õß°“√¬Õ¡√—∫¢Õßº≈°“√∑¥ Õ∫·µà≈–§√—Èß ‡¡◊ËÕ¡’°“√∑” È”„πµ—«Õ¬à“ß∑’Ë‡ªìπ‡π◊ÈÕ‡¥’¬«°—π

§«“¡‡∑’Ë¬ß¡—°°”Àπ¥‡ªìπ§à“‡∫’Ë¬ß‡∫π¡“µ√∞“π —¡æ—∑∏åÕ“®æ‘®“√≥“‰¥â 3 √–¥—∫

- repeatability: °“√∑¥ Õ∫´È” ¿“¬„µâ ¿“«–°“√∑¥ Õ∫‡¥’¬«°—π„π√–¬–‡«≈“ —ÈπÊ

- intermediate precision: °“√∑¥ Õ∫ È” ¿“¬„πÀâÕßªØ‘∫—µ‘°“√‡¥’¬«°—π ·µàµà“ß«—π µà“ßºŸâ∑¥ Õ∫

À√◊Õµà“ß‡§√◊ËÕß¡◊Õ

- reproducibility: °“√∑¥ Õ∫´È” µà“ßÀâÕßªØ‘∫—µ‘°“√

“√Õâ“ßÕ‘ßÀ√◊Õ “√¡“µ√∞“π √–¥—∫ª∞¡¿Ÿ¡‘

“√„¥Ê ÷Ëß‡ªìπ∑’Ë¬Õ¡√—∫°—πÕ¬à“ß°«â“ß¢«“ß«à“¡’§ÿ≥¿“æ∑’Ë‡À¡“– ¡ ”À√—∫°“√„™âß“π‡©æ“–¥â“π ·≈–

‰¥â√—∫°“√¬Õ¡√—∫§à“∑’Ë∂Ÿ°°”Àπ¥‰«â‚¥¬‰¡àµâÕß¡’°“√‡ª√’¬∫‡∑’¬∫°—∫ “√‡§¡’Õ◊Ëπ (8)

À¡“¬‡Àµÿ: “√¡“µ√∞“πÕâ“ßÕ‘ß∑“ß‡§¡’∑’Ë√–∫ÿ„πµ”√“¬“∂◊Õ«à“‡ªìπ “√¡“µ√∞“π√–¥—∫ª∞¡¿Ÿ¡‘ ºŸâº≈‘µ

∑’Ë‰¡à¡’ “√Õâ“ßÕ‘ß∑’Ë√–∫ÿ„πµ”√“¬“§«√®—¥„Àâ¡’ “√Õâ“ßÕ‘ß√–¥—∫ª∞¡¿Ÿ¡‘¢÷Èπ

§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ

°“√æ‘ Ÿ®πå ·≈–°“√∫—π∑÷°‰«â„π‡Õ° “√«à“‡§√◊ËÕß¡◊Õ°“√«‘‡§√“–Àå¡’§«“¡ Õ¥§≈âÕß°—∫§ÿ≥≈—°…≥–∑’Ë

µâÕß°“√·≈– “¡“√∂„™âß“π‰¥âÕ¬à“ß‡À¡“– ¡µ“¡«—µ∂ÿª√– ß§å (¥Ÿ à«π∑’Ë 2 ¢âÕ 12)

°“√§«∫§ÿ¡§ÿ≥¿“æ

¡“µ√°“√∑—ÈßÀ¡¥ √«¡∂÷ß °“√µ—Èß¢âÕ°”Àπ¥¡“µ√∞“π °“√ ÿà¡µ—«Õ¬à“ß °“√∑¥ Õ∫ ·≈–°“√

µ√«®«‘‡§√“–Àå∑—ÈßÀ¡¥ ‡æ◊ËÕ„Àâ·πà„®«à“ «—µ∂ÿ¥‘∫ ¬“°÷Ëß ”‡√Á®√Ÿª «— ¥ÿ ”À√—∫°“√∫√√®ÿ ·≈–‡¿ —™¿—≥±å ”‡√Á®√Ÿª

Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥∑’Ë«à“¥â«¬°“√æ‘ Ÿ®πå‡Õ°≈—°…≥å §«“¡·√ß §«“¡∫√‘ ÿ∑∏‘Ï ·≈–§ÿ≥≈—°…≥–Õ◊ËπÊ

√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

√–∫∫æ◊Èπ∞“π∑’Ë‡À¡“– ¡ ÷Ëß√«¡∂÷ß‚§√ß √â“ß¢ÕßÕß§å°√ ¢—ÈπµÕπ °√–∫«π°“√·≈–∑√—æ¬“°√ √«¡∑—Èß

°“√ªØ‘∫—µ‘ß“πÕ¬à“ß‡ªìπ√–∫∫ ´÷Ëß®”‡ªìπµàÕ§«“¡‡™◊ËÕ¡—ËπÕ¬à“ß‡æ’¬ßæÕ«à“º≈‘µ¿—≥±åÀ√◊Õ∫√‘°“√®–‡ªìπ‰ªµ“¡

¢âÕ°”Àπ¥¥â“π§ÿ≥¿“æµ“¡∑’Ë·®âß‰«â (¥Ÿ à«π∑’Ë 1 ¢âÕ 2)

ºŸâ®—¥°“√¥â“π§ÿ≥¿“æ

∫ÿ§≈“°√Àπ÷Ëß„πºŸâªØ‘∫—µ‘ß“π∑’Ë‰¥â√—∫¡Õ∫Õ”π“®Àπâ“∑’Ë·≈–§«“¡√—∫º‘¥™Õ∫„π°“√∑”„Àâ¡—Ëπ„®«à“¡’°“√

π”√–∫∫°“√∫√‘À“√ß“π∑’Ë‡°’Ë¬«¢âÕß°—∫§ÿ≥¿“æ‰ª„™â·≈–ªØ‘∫—µ‘µ“¡µ≈Õ¥‡«≈“ (¥Ÿ à«π∑’Ë 1 ¢âÕ 1.3 (j))



16

quality manual

A handbook that describes the various elements of the quality management system forassuring the quality of the test results generated by a laboratory (see Part one, sections 2.1-2.2).

quality unit(s)

An organizational unit, independent of production, which fulfils both quality assuranceand quality control responsibilities. This can be in the form of separate quality assurance andquality control or a single individual or group, depending on the size and structure of theorganization.

reference material

Material sufficiently homogeneous and stable with respect to one or more specifiedproperties, which has been established to be fit for its intended use in a measurement process (4).

reference substance (or standard)

An authenticated, uniform material that is intended for use in specified chemical andphysical tests, in which its properties are compared with those of the product under examination,and which possesses a degree of purity adequate for its intended use (8).

secondary reference substance (or standard)

A substance whose characteristics are assigned and/or calibrated by comparison witha primary reference substance. The extent of characterization and testing of a secondaryreference substance may be less than for a primary reference substance (8).

Note: Often referred to as an çin-houseé working standard.

signature (signed)

Record of the individual who performed a particular action or review. The record can beinitials, full handwritten signature, personal seal or authenticated and secure electronic signature.

specification

A list of detailed requirements (acceptance criteria for the prescribed test procedures)with which the substance or pharmaceutical product has to conform to ensure suitable quality.

standard operating procedure (SOP)

An authorized written procedure giving instructions for performing operations bothgeneral and specific.


17À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

§Ÿà¡◊Õ¥â“π§ÿ≥¿“æ

§Ÿà¡◊Õ∑’ËÕ∏‘∫“¬∂÷ßÕß§åª√–°Õ∫µà“ßÊ ¢Õß√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ ‡æ◊ËÕª√–°—π§ÿ≥¿“æ¢Õß

º≈°“√∑¥ Õ∫∑“ßÀâÕßªØ‘∫—µ‘°“√ (¥Ÿ à«π∑’Ë 1 ¢âÕ 2.1 - 2.2)

Àπà«¬ß“π¥â“π§ÿ≥¿“æ

Àπà«¬Àπ÷Ëß¢ÕßÕß§å°√∑’Ë‡ªìπÕ‘ √–®“°ΩÉ“¬º≈‘µ ´÷Ëß¡’Àπâ“∑’Ë√—∫º‘¥™Õ∫¥â“πª√–°—π§ÿ≥¿“æ·≈–§«∫§ÿ¡

§ÿ≥¿“æ ΩÉ“¬ª√–°—π§ÿ≥¿“æ·≈–ΩÉ“¬§«∫§ÿ¡§ÿ≥¿“æÕ“®®–·¬°°—πÀ√◊Õ¡’‡©æ“–ΩÉ“¬„¥ΩÉ“¬Àπ÷Ëß À√◊Õ√«¡°—π

‡ªìπ°≈ÿà¡‡¥’¬« ∑—Èßπ’È¢÷ÈπÕ¬Ÿà°—∫¢π“¥·≈–‚§√ß √â“ß¢ÕßÕß§å°√

«— ¥ÿÕâ“ßÕ‘ß

«— ¥ÿ∑’Ë¡’§«“¡‡ªìπ‡π◊ÈÕ‡¥’¬«°—π·≈–§ß ¿“æ ‚¥¬¡’§ÿ≥ ¡∫—µ‘‡©æ“–Õ¬à“ß„¥Õ¬à“ßÀπ÷ËßÀ√◊Õ¡“°°«à“

´÷Ëß‰¥â∂Ÿ°°”Àπ¥‰«â‡æ◊ËÕ„Àâ‡À¡“– ¡µ“¡«—µ∂ÿª√– ß§å∑’Ëπ”‰ª„™â„π°√–∫«π°“√«—¥ (4)

“√Õâ“ßÕ‘ßÀ√◊Õ “√¡“µ√∞“π

«— ¥ÿ∑’Ëºà“π°“√√—∫√Õß·≈–¡’§«“¡ ¡Ë”‡ ¡Õ ´÷Ëß¡’«—µ∂ÿª√– ß§å‡æ◊ËÕπ”‰ª„™â„π°“√∑¥ Õ∫‡©æ“–∑“ß¥â“π

‡§¡’·≈–øî ‘° å ‚¥¬π”§ÿ≥ ¡∫—µ‘¢Õß “√Õâ“ßÕ‘ß¡“„™â‡ª√’¬∫‡∑’¬∫°—∫º≈‘µ¿—≥±å∑’Ëπ”¡“∑¥ Õ∫ ·≈–¡’√–¥—∫¢Õß

§«“¡∫√‘ ÿ∑∏‘Ï‡æ’¬ßæÕ ”À√—∫«—µ∂ÿª√– ß§å∑’Ë®–π”‰ª„™â (8)

“√Õâ“ßÕ‘ßÀ√◊Õ “√¡“µ√∞“π √–¥—∫∑ÿµ‘¬¿Ÿ¡‘

“√ ÷Ëß‰¥â°”Àπ¥·≈–/À√◊Õ‡∑’¬∫§ÿ≥≈—°…≥–°—∫ “√Õâ“ßÕ‘ß√–¥—∫ª∞¡¿Ÿ¡‘ ´÷Ëß¢Õ∫‡¢µ¢Õß§ÿ≥≈—°…≥–

·≈–°“√∑¥ Õ∫ “√Õâ“ßÕ‘ß√–¥—∫∑ÿµ‘¬¿Ÿ¡‘Õ“®®–πâÕ¬«à“ “√Õâ“ßÕ‘ß√–¥—∫ª∞¡¿Ÿ¡‘‰¥â (8)

À¡“¬‡Àµÿ: ¡—°®–Õâ“ßÕ‘ß«à“‡ªìπ çin-houseé working standard

°“√≈ßπ“¡°”°—∫

À≈—°∞“π°“√∫—π∑÷°¢Õß·µà≈–∫ÿ§§≈∑’Ë· ¥ß«à“‰¥âªØ‘∫—µ‘À√◊Õ∑∫∑«πß“π À≈—°∞“π°“√∫—π∑÷°π’ÈÕ“®®–‡ªìπ

§”¬àÕ ≈“¬¡◊Õ™◊ËÕ·∫∫‡µÁ¡ ª√–∑—∫µ√“ à«π∫ÿ§§≈ À√◊Õ≈“¬¡◊Õ™◊ËÕ·∫∫Õ‘‡≈Á°∑√Õπ‘° å

¢âÕ°”Àπ¥¡“µ√∞“π

√“¬°“√¢Õß¢âÕ°”Àπ¥æ√âÕ¡√“¬≈–‡Õ’¬¥ (‡°≥±å°“√¬Õ¡√—∫¢Õß°√–∫«π°“√∑¥ Õ∫µà“ßÊ ∑’Ë√–∫ÿ‰«â)

´÷Ëß “√À√◊Õ‡¿ —™¿—≥±å®–µâÕß¡’§ÿ≥¿“æ Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥·≈–‡°≥±å‡æ◊ËÕ√—∫√Õß«à“¡’§ÿ≥¿“æµ“¡∑’Ë°”Àπ¥

¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π

«‘∏’¥”‡π‘π°“√∑’Ë‰¥â√—∫Õπÿ≠“µ„Àâ®—¥∑”¢÷Èπ ‡æ◊ËÕ„Àâ§”·π–π”„π°“√ªØ‘∫—µ‘ß“π ∑—Èß°“√ªØ‘∫—µ‘ß“π∑—Ë«‰ª·≈–

°“√ªØ‘∫—µ‘ß“π‡©æ“–¥â“π



18

standard uncertainty

Uncertainty of the result of a measurement expressed as a standard deviation (4, 9, 10).

system suitability test

A test which is performed to ensure that the analytical procedure fulfils the acceptancecriteria which had been established during the validation of the procedure. This test is performedbefore starting the analytical procedure and is to be repeated regularly, as appropriate, throughoutthe analytical run to ensure that the systemûs performance is acceptable at the time of the test.

validation of an analytical procedure

The documented process by which an analytical procedure (or method) is demonstratedto be suitable for its intended use.

verification of an analytical procedure

Process by which a pharmacopoeial method or validated analytical procedure isdemonstrated to be suitable for the analysis to be performed.

verification of performance

Test procedure regularly applied to a system (e.g. liquid chromatographic system) todemonstrate consistency of response.

Part one. Management and infrastructure

1. Organization and management

1.1 The laboratory, or the organization of which it is part, should be an entity that islegally authorized to function and can be held legally responsible.

1.2 The laboratory should be organized and operate so as to meet the requirementslaid down in these guidelines.

1.3 The laboratory should:

(a) have managerial and technical personnel with the authority and resources neededto carry out their duties and to identify the occurrence of departures from thequality management system or the procedures for performing tests and/orcalibrations, validation and verification, and to initiate actions to prevent orminimize such departures;

(b) have arrangements to ensure that its management and personnel are not subjectto commercial, political, financial and other pressures or conflicts of interest thatmay adversely affect the quality of their work;


19À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

§à“§«“¡‰¡à·πàπÕπ¡“µ√∞“π

§à“§«“¡‰¡à·πàπÕπ¢Õßº≈∑’Ë‰¥â®“°°“√«—¥∑’Ë· ¥ß¥â«¬§à“‡∫’Ë¬ß‡∫π¡“µ√∞“π (4, 9, 10)

°“√∑¥ Õ∫§«“¡‡À¡“– ¡¢Õß√–∫∫

°“√∑¥ Õ∫‡æ◊ËÕ„Àâ¡—Ëπ„®«à“¢—ÈπµÕπ°“√«‘‡§√“–Àåπ—Èπ ºà“π‡°≥±å°“√¬Õ¡√—∫ ÷Ëß∂Ÿ°°”Àπ¥¢÷Èπ„π√–À«à“ß

∑’Ëµ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß«‘∏’°“√«‘‡§√“–Àå ‚¥¬°“√∑¥ Õ∫π’È°√–∑”°àÕπ°“√‡√‘Ë¡¢—ÈπµÕπ°“√«‘‡§√“–Àå·≈–

§«√∑”´È”µ“¡§«“¡‡À¡“– ¡µ≈Õ¥™à«ß‡«≈“∑’Ë∑”°“√«‘‡§√“–Àå ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“ ¡√√∂π–¢Õß√–∫∫¬—ß‡ªìπ∑’Ë¬Õ¡√—∫

„π™à«ß‡«≈“∑’Ë∑”°“√∑¥ Õ∫

°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß«‘∏’°“√«‘‡§√“–Àå

°√–∫«π°“√∑’Ë‰¥â®—¥∑”‡ªìπ‡Õ° “√‡æ◊ËÕ· ¥ß«à“ ¢—ÈπµÕπ¥”‡π‘π°“√µ√«®«‘‡§√“–Àå (À√◊Õ«‘∏’«‘‡§√“–Àå)

¡’§«“¡‡À¡“– ¡µ√ßµ“¡«—µ∂ÿª√– ß§å„π°“√π”‰ª„™â

°“√∑«π Õ∫«‘∏’°“√«‘‡§√“–Àå

°√≥’„™â«‘∏’«‘‡§√“–Àåµ“¡µ”√“¬“À√◊Õ¢—ÈπµÕπ¥”‡π‘π°“√µ√«®«‘‡§√“–Àå∑’Ëºà“π°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß

¢Õß«‘∏’«‘‡§√“–Àå·≈â« µâÕß¡’°√–∫«π°“√∑’Ë· ¥ß„Àâ‡ÀÁπ«à“«‘∏’«‘‡§√“–Àåπ—Èπ‡À¡“– ¡ ”À√—∫π”¡“„™â„π°“√«‘‡§√“–Àå

°“√∑«π Õ∫ ¡√√∂π–

¢—ÈπµÕπ°“√∑¥ Õ∫∑’Ë„™âª√–®”„π√–∫∫ (µ—«Õ¬à“ß‡™àπ liquid chromatographic system) ∑’Ë· ¥ß∂÷ß

°“√µÕ∫ πÕßÕ¬à“ß ¡Ë”‡ ¡Õ

à«π∑’Ë 1 °“√∫√‘À“√®—¥°“√ ·≈–‚§√ß √â“ßæ◊Èπ∞“π¢ÕßÕß§å°√

1. Õß§å°√·≈–°“√∫√‘À“√®—¥°“√

1.1 ÀâÕßªØ‘∫—µ‘°“√À√◊ÕÕß§å°√∑’Ë¡’ÀâÕßªØ‘∫—µ‘°“√‡ªìπ à«πÀπ÷Ëß¢ÕßÕß§å°√ §«√‰¥â√—∫°“√·µàßµ—Èß

µ“¡°ÆÀ¡“¬„ÀâªØ‘∫—µ‘ß“π¿“¬„µâ¢Õ∫‡¢µ§«“¡√—∫º‘¥™Õ∫µ“¡∑’Ë°ÆÀ¡“¬°”Àπ¥

1.2 ÀâÕßªØ‘∫—µ‘°“√§«√‰¥â√—∫°“√®—¥µ—Èß·≈–¥”‡π‘π°“√‡æ◊ËÕ„Àâ‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥∑’Ë√–∫ÿ‰«â„π·π«ªØ‘∫—µ‘π’È

1.3 ÀâÕßªØ‘∫—µ‘°“√§«√¡’§ÿ≥ ¡∫—µ‘¥—ßπ’È:

(a) ¡’∫ÿ§≈“°√¥â“π∫√‘À“√·≈–¥â“π«‘™“°“√´÷Ëß¡’Õ”π“®Àπâ“∑’Ë ·≈–¡’∑√—æ¬“°√∑’Ë®”‡ªìπµàÕ°“√

¥”‡π‘πß“πµ“¡Àπâ“∑’Ë ·≈–™’È∫àß°“√‡°‘¥°“√‡∫’Ë¬ß‡∫π‰ª®“°√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

À√◊Õ®“°¢—ÈπµÕπ°“√¥”‡π‘πß“π¿“¬„π °“√∑”°“√∑¥ Õ∫·≈–/À√◊Õ Õ∫‡∑’¬∫ °“√µ√«® Õ∫

§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫ ·≈–„π°“√°”Àπ¥ªØ‘∫—µ‘°“√‡æ◊ËÕªÑÕß°—πÀ√◊Õ≈¥°“√‡∫’Ë¬ß‡∫π

π—Èπ„ÀâπâÕ¬≈ß

(b) ¡’°“√®—¥°“√‡æ◊ËÕ„Àâ¡—Ëπ„®«à“ºŸâ∫√‘À“√ß“π ·≈–∫ÿ§≈“°√¡‘‰¥âÕ¬Ÿà¿“¬„µâÕ‘∑∏‘æ≈ ∑“ß°“√§â“

°“√‡¡◊Õß °“√‡ß‘π À√◊Õ°“√¡’ à«π‰¥â à«π‡ ’¬ ´÷ËßÕ“® àßº≈°√–∑∫µàÕ§ÿ≥¿“æ¢Õß°“√ªØ‘∫—µ‘ß“π



20

(c) have a policy and procedure in place to ensure confidentiality of

- information contained in marketing authorizations,

- transfer of results or reports,

- and to protect data in archives (paper and electronic);

(d) define, with the aid of organizational charts, the organization and managementstructure of the laboratory, its place in any parent organization (such as theministry or the NMRA in the case of a national pharmaceutical qualitycontrol laboratory), and the relationships between management, technicaloperations, support services and the quality management system;

(e) specify the responsibility, authority and interrelationships of all personnel whomanage, perform or verify work which affects the quality of the tests and/orcalibrations, validations and verifications;

(f) ensure the precise allocation of responsibilities, particularly in the designationof specific units for particular types of medicines;

(g) nominate trained substitutes/deputies for key management and specializedscientific personnel;

(h) provide adequate supervision of staff, including trainees, by persons familiar withthe test and/or calibration, validation and verification methods and procedures,as well as their purpose and the assessment of the results;

(i) have management which has overall responsibility for the technical operationsand the provision of resources needed to ensure the required quality oflaboratory operations;

(j) designate a member of staff as quality manager who, irrespective of other dutieshe/she may have, will ensure compliance with the quality management system.The nominated quality manager should have direct access to the highest levelof management at which decisions are taken on laboratory policies or resources;

(k) ensure adequate information flow between staff at all levels. Staff are to bemade aware of the relevance and importance of their activities;

(l) ensure the traceability of the sample from receipt, throughout the stages of testing,to the completion of the analytical test report;

(m) maintain an up-to-date collection of all specifications and related documents(paper or electronic) used in the laboratory; and

(n) have appropriate safety procedures (see Part four).


21À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(c) ¡’π‚¬∫“¬·≈–¢—ÈπµÕπ¥”‡π‘π°“√√—°…“§«“¡≈—∫‡°’Ë¬«°—∫

- ¢âÕ¡Ÿ≈¥â“π°“√µ≈“¥

- °“√∂à“¬‚Õπº≈°“√µ√«®«‘‡§√“–Àå/√“¬ß“πµà“ßÊ

- ·≈–°“√ªÑÕß°—π¢âÕ¡Ÿ≈ ”§—≠µà“ßÊ (∑—Èß∑’Ë‡°Á∫Õ¬Ÿà„π√Ÿª‡Õ° “√·≈–Õ‘‡≈Á°∑√Õπ‘° å)

(d) °”Àπ¥‚§√ß √â“ßÕß§å°√·≈–°“√∫√‘À“√¢ÕßÀâÕßªØ‘∫—µ‘°“√ ∂“π–¢ÕßÀâÕßªØ‘∫—µ‘°“√

„πÕß§å°√„À≠à ´÷ËßÕ“®· ¥ß‡ªìπ·ºπº—ß· ¥ß‚§√ß √â“ßÕß§å°√ (‡™àπ °√–∑√«ß À√◊Õ NMRA

„π°√≥’¢ÕßÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å√–¥—∫™“µ‘ ‡ªìπµâπ) ·≈–§«“¡ —¡æ—π∏å

√–À«à“ß°“√∫√‘À“√ °“√¥”‡π‘π°“√∑“ß«‘¢“°“√·≈–°“√ π—∫ πÿπµà“ßÊ ·≈–√–∫∫∫√‘À“√

®—¥°“√¥â“π§ÿ≥¿“æ

(e) √–∫ÿ§«“¡√—∫º‘¥™Õ∫ Õ”π“®Àπâ“∑’Ë ·≈–§«“¡ —¡æ—π∏å√–À«à“ß°—π¢Õß∫ÿ§≈“°√∑—ÈßÀ¡¥ºŸâ∑”Àπâ“∑’Ë

„π°“√∫√‘À“√ ªØ‘∫—µ‘°“√ À√◊Õ∑«π Õ∫ß“π∑’Ë¡’º≈µàÕ§ÿ≥¿“æ¢Õß°“√∑¥ Õ∫·≈–/À√◊Õ

°“√ Õ∫‡∑’¬∫ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫

(f) ¡—Ëπ„®«à“¡’°“√√–∫ÿ¢Õ∫‡¢µ§«“¡√—∫º‘¥™Õ∫∑’Ë™—¥‡®π ”À√—∫Àπà«¬ß“π∑’Ë‰¥â√—∫°“√·µàßµ—Èß¢÷Èπ

‡æ◊ËÕ∑”°“√µ√«®«‘‡§√“–Àå¬“‡©æ“–°≈ÿà¡

(g) ·µàßµ—ÈßºŸâªØ‘∫—µ‘ß“π·∑π ”À√—∫∫ÿ§≈“°√∑’Ë ”§—≠Ê ∑“ß¥â“π°“√∫√‘À“√·≈– ºŸâ‡™’Ë¬«™“≠

(h) ®—¥„Àâ¡’°“√§«∫§ÿ¡ß“π∑’Ë‡æ’¬ßæÕµàÕºŸâªØ‘∫—µ‘ß“π √«¡∂÷ßºŸâΩñ°ß“π ‚¥¬∫ÿ§≈“°√∑’Ë§ÿâπ‡§¬°—∫

«‘∏’°“√∑¥ Õ∫ ·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫ ·≈–

¢—ÈπµÕπ°“√¥”‡π‘πß“π √«¡∑—Èß«—µ∂ÿª√– ß§å ·≈–°“√ª√–‡¡‘πº≈

(i) ¡’ºŸâ∫√‘À“√®—¥°“√´÷Ëß√—∫º‘¥™Õ∫∑—ÈßÀ¡¥‡°’Ë¬«°—∫°“√¥”‡π‘π°“√¥â“π«‘™“°“√ ·≈–°“√®—¥À“

∑√—æ¬“°√∑’Ë®”‡ªìπ ‡æ◊ËÕ„Àâ¡—Ëπ„®„π§ÿ≥¿“æµ“¡∑’ËµâÕß°“√ ”À√—∫°“√¥”‡π‘π°“√µà“ßÊ ¢Õß

ÀâÕßªØ‘∫—µ‘°“√

(j) ·µàßµ—ÈßºŸâªØ‘∫—µ‘ß“π§πÀπ÷Ëß‡ªìπºŸâ®—¥°“√¥â“π§ÿ≥¿“æ ÷ËßπÕ°‡Àπ◊Õ®“°Àπâ“∑’Ë§«“¡√—∫º‘¥™Õ∫Õ◊ËπÊ

‡æ◊ËÕ¥Ÿ·≈√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ ºŸâ®—¥°“√¥â“π§ÿ≥¿“æπ’È §«√µ‘¥µàÕ‰¥â‚¥¬µ√ß°—∫

ºŸâ∫√‘À“√√–¥—∫ Ÿß ÿ¥∑’Ë¡’Õ”π“®„π°“√µ—¥ ‘π„®‡°’Ë¬«°—∫π‚¬∫“¬À√◊Õ∑√—æ¬“°√¢ÕßÀâÕßªØ‘∫—µ‘°“√

(k) ¡—Ëπ„®«à“¡’°“√ àßµàÕ¢âÕ¡Ÿ≈¢à“« “√√–À«à“ßºŸâªØ‘∫—µ‘ß“π„π∑ÿ°√–¥—∫ µ√–Àπ—°∂÷ß§«“¡‡°’Ë¬«¢âÕß

·≈–§«“¡ ”§—≠¢Õß°‘®°√√¡¢Õß‡¢“

(l) ¡—Ëπ„®«à“ “¡“√∂µ√«® Õ∫¬âÕπ°≈—∫µ—«Õ¬à“ß‰¥â µ—Èß·µà°“√√—∫µ—«Õ¬à“ß µ≈Õ¥™à«ß¢Õß¢—ÈπµÕπ

°“√∑¥ Õ∫‰ª®π∂÷ß√“¬ß“πº≈°“√µ√«®«‘‡§√“–Àå

(m) ¡’°“√·°â‰¢¢âÕ°”Àπ¥¡“µ√∞“π·≈–‡Õ° “√∑’Ë‡°’Ë¬«¢âÕß∑’Ë„™â„πÀâÕßªØ‘∫—µ‘°“√„Àâ‡ªìπªí®®ÿ∫—π

Õ¬Ÿà‡ ¡Õ (∑—Èß„π√Ÿª‡Õ° “√À√◊Õ‡Õ° “√∑“ßÕ‘‡≈Á°∑√Õπ‘° å) ·≈–

(n) ¡’«‘∏’°“√√—°…“§«“¡ª≈Õ¥¿—¬∑’Ë‡À¡“– ¡ (¥Ÿ à«π∑’Ë 4)



22

1.4 The laboratory should maintain a registry with the following functions:

(a) receiving, distributing and supervising the consignment of the samples to thespecific units; and

(b) keeping records on all incoming samples and accompanying documents.

1.5 In a large laboratory, it is necessary to guarantee communication and coordinationbetween the staff involved in the testing of the same sample in different units.

2. Quality management system

2.1 The laboratory or organization management should establish, implement and maintaina quality management system appropriate to the scope of its activities, including the type, rangeand volume of testing and/or calibration, validation and verification activities it undertakes.The laboratory management should ensure that its policies, systems, programmes, proceduresand instructions are described to the extent necessary to enable the laboratory to assure the qualityof the test results that it generates. The documentation used in this quality managementsystem should be communicated, available to, and understood and implemented by, theappropriate personnel. The elements of this system should be documented, e.g. in a qualitymanual, for the organization as a whole and/or for a laboratory within the organization.

Note: Quality control laboratories of a manufacturer may have this information in otherdocuments than a quality manual.

2.2 The quality manual should contain as a minimum:

(a) a quality policy statement, including at least the following:

(i) a statement of the laboratory managementûs intentions with respect to thestandard of service it will provide,

(ii) a commitment to establishing, implementing and maintaining an effectivequality management system,

(iii) the laboratory managementûs commitment to good professional practice andquality of testing, calibration, validation and verification,

(iv) the laboratory managementûs commitment to compliance with the contentof these guidelines,

(v) a requirement that all personnel concerned with testing and calibrationactivities within the laboratory familiarize themselves with the documentationconcerning quality and the implementation of the policies and procedures intheir work;


23À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

1.4 ÀâÕßªØ‘∫—µ‘°“√§«√¡’°“√°”Àπ¥Àπâ“∑’Ë¥—ßµàÕ‰ªπ’È:

(a) °“√√—∫ ·®°®à“¬ ·≈–µ√«® Õ∫µ—«Õ¬à“ß∑’Ë®– àß‰ª¬—ßÀπà«¬ªØ‘∫—µ‘ß“π‡©æ“– ·≈–

(b) ‡°Á∫∫—π∑÷°¢âÕ¡Ÿ≈‡°’Ë¬«°—∫µ—«Õ¬à“ß∑’Ë‰¥â√—∫·≈–‡Õ° “√∑’Ë·π∫¡“æ√âÕ¡µ—«Õ¬à“ß∑ÿ°©∫—∫

1.5 ”À√—∫ÀâÕßªØ‘∫—µ‘°“√¢π“¥„À≠à ®”‡ªìπµâÕß¡’√–∫∫°“√ ◊ËÕ “√·≈–ª√– “πß“π∑’Ë¥’ √–À«à“ßºŸâªØ‘∫—µ‘

ß“π®“°Àπà«¬ß“πµà“ßÊ ∑’Ë‡°’Ë¬«¢âÕß°—∫°“√∑¥ Õ∫µ—«Õ¬à“ß‡¥’¬«°—π

2. √–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

2.1 ºŸâ∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√À√◊ÕÕß§å°√§«√¡’°“√®—¥∑” π”‰ª„™â·≈–√—°…“‰«â´÷Ëß√–∫∫∫√‘À“√®—¥°“√

¥â“π§ÿ≥¿“æ∑’Ë‡À¡“– ¡°—∫¢Õ∫¢à“¬¢Õß°‘®°√√¡ √«¡∂÷ßª√–‡¿∑ ¢Õ∫‡¢µ·≈–ª√‘¡“≥ß“πµ√«®«‘‡§√“–Àå

·≈–/À√◊Õß“π Õ∫‡∑’¬∫ ß“πµ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–ß“π∑«π Õ∫ ºŸâ∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√§«√¡’°“√°”Àπ¥

π‚¬∫“¬ √–∫∫ ‚ª√·°√¡¢—ÈπµÕπ·≈–§”·π–π”µà“ßÊ µ“¡¢Õ∫‡¢µ§«“¡®”‡ªìπ ‡æ◊ËÕ„Àâ¡—Ëπ„®„π§ÿ≥¿“æ¢Õß

º≈°“√µ√«®«‘‡§√“–Àå ‡Õ° “√µà“ßÊ∑’Ë„™â„π√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ ‡™àπ §Ÿà¡◊Õ¥â“π§ÿ≥¿“æ ”À√—∫Õß§å°√

·≈–/À√◊Õ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«√‰¥â√—∫°“√®—¥∑”‡ªìπ‡Õ° “√ ·®âß„Àâ∫ÿ§≈“°√∑’Ë‡°’Ë¬ß¢âÕß∑√“∫ ∑”§«“¡‡¢â“„®

¡’‰«â„Àâ„™â ·≈–π”‰ª„™âªØ‘∫—µ‘

À¡“¬‡Àµÿ : ¢âÕ¡Ÿ≈π’ÈÕ“®‰¥â√—∫°“√∫√√®ÿÕ¬Ÿà„π§Ÿà¡◊Õ¥â“π§ÿ≥¿“æ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ

¢ÕßºŸâº≈‘µ

2.2 §Ÿà¡◊Õ¥â“π§ÿ≥¿“æ Õ¬à“ßπâÕ¬§«√¡’‡π◊ÈÕÀ“ ¥—ßπ’È:

(a) π‚¬∫“¬Õ¬à“ß‡ªìπ∑“ß°“√¥â“π§ÿ≥¿“æ Õ¬à“ßπâÕ¬§«√¡’‡π◊ÈÕÀ“ ¥—ßµàÕ‰ªπ’È:

(i) ∂âÕ¬·∂≈ßºŸâ∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√‡°’Ë¬«°—∫¡“µ√∞“π°“√„Àâ∫√‘°“√¢ÕßÀâÕßªØ‘∫—µ‘°“√

(ii) ¢âÕºŸ°æ—π„π°“√®—¥µ—Èß ¥”‡π‘π°“√ ·≈–√—°…“‰«â´÷Ëß√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ∑’Ë¡’

ª√– ‘∑∏‘¿“æ

(iii) ¢âÕºŸ°æ—π¢ÕßºŸâ∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√„Àâ¡’°“√ªØ‘∫—µ‘ß“πÕ¬à“ß¡◊ÕÕ“™’æ∑’Ë¥’ ·≈–¥â«¬§ÿ≥¿“æ

„π°“√∑¥ Õ∫ °“√ Õ∫‡∑’¬∫ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫

(iv) ¢âÕºŸ°æ—π¢ÕßºŸâ∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√∑’Ë®–ªØ‘∫—µ‘„Àâ‡ªìπ‰ªµ“¡·π«∑“ßªØ‘∫—µ‘π’È

(v) °“√°”Àπ¥„Àâ∫ÿ§≈“°√∑—ÈßÀ¡¥∑’Ë‡°’Ë¬«¢âÕß°—∫°‘®°√√¡°“√∑¥ Õ∫·≈– Õ∫‡∑’¬∫¿“¬„π

ÀâÕßªØ‘∫—µ‘°“√®–µâÕß∑”§«“¡§ÿâπ‡§¬°—∫‡Õ° “√§ÿ≥¿“æ ·≈–π”π‚¬∫“¬·≈–¢—ÈπµÕπ

°“√¥”‡π‘πß“π‰ª„™â„πß“π¢Õßµπ



24

(b) the structure of the laboratory (organizational chart);

(c) the operational and functional activities pertaining to quality, so that the extentand the limits of the responsibilities are clearly defined;

(d) outline of the structure of documentation used in the laboratory qualitymanagement system;

(e) the general internal quality management procedures;

(f) references to specific procedures for each test;

(g) information on the appropriate qualifications, experience and competenciesthat personnel are required to possess;

(h) information on initial and in-service training of staff;

(i) a policy for internal and external audit;

(j) a policy for implementing and verifying corrective and preventive actions;

(k) a policy for dealing with complaints;

(l) a policy for performing management reviews of the quality management system;

(m) a policy for selecting, establishing and approving analytical procedures;

(n) a policy for handling of OOS results;

(o) a policy for the employment of appropriate reference substances and referencematerials;

(p) a policy for participation in appropriate proficiency testing schemes and collaborativetrials and the evaluation of the performance (applicable to national pharmaceuticalquality control laboratories, but may be applied by other laboratories); and

(q) a policy to select service providers and suppliers.

2.3 The laboratory should establish, implement and maintain authorized written SOPsincluding, but not limited to, administrative and technical operations, such as:

(a) personnel matters, including qualifications, training, clothing and hygiene;

(b) the change control;

(c) internal audit;

(d) dealing with complaints;

(e) implementation and verification of corrective and preventive actions;

(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);


25À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(b) ‚§√ß √â“ß¢ÕßÀâÕßªØ‘∫—µ‘°“√ (·ºπº—ß· ¥ß‚§√ß √â“ßÕß§å°√)

(c) ∫∑∫“∑·≈–Àπâ“∑’Ë§«“¡√—∫º‘¥™Õ∫„π°“√ªØ‘∫—µ‘ß“π¥â“π§ÿ≥¿“æ ‚¥¬„π§Ÿà¡◊ÕµâÕß√–∫ÿ¢Õ∫‡¢µ

§«“¡√—∫º‘¥™Õ∫‡°’Ë¬«°—∫ß“π ¥â“π§ÿ≥¿“æ‰«âÕ¬à“ß™—¥‡®π

(d) ‚§√ß √â“ß¢Õß√–∫∫‡Õ° “√ ÷Ëß„™â„π√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ¢ÕßÀâÕßªØ‘∫—µ‘°“√

(e) À≈—°ªØ‘∫—µ‘∑—Ë«‰ª¢Õß°“√∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ¿“¬„πÀπà«¬ß“π

(f) ·À≈àß¢âÕ¡Ÿ≈Õâ“ßÕ‘ß¢Õß¢—ÈπµÕπ„π·µà≈–°“√∑¥ Õ∫

(g) ¢âÕ¡Ÿ≈‡°’Ë¬«°—∫§ÿ≥ ¡∫—µ‘ ª√– ∫°“√≥å ·≈–§«“¡√Ÿâ§«“¡ “¡“√∂∑’Ë®”‡ªìπµàÕ°“√ªØ‘∫—µ‘ß“π¢Õß

∫ÿ§≈“°√„π·µà≈–µ”·Àπàß

(h) ¢âÕ¡Ÿ≈°“√Ωñ°Õ∫√¡ °àÕπ°“√ªØ‘∫—µ‘ß“π·≈–√–À«à“ß°“√ªØ‘∫—µ‘ß“π¢Õß∫ÿ§≈“°√

(i) π‚¬∫“¬°“√µ√«®µ‘¥µ“¡¿“¬„π·≈–°“√µ√«®µ‘¥µ“¡‚¥¬Àπà«¬ß“π¿“¬πÕ°

(j) π‚¬∫“¬ ”À√—∫°“√ª√–°“»„™â·≈–°“√∑«π Õ∫¡“µ√°“√·°â‰¢·≈–ªÑÕß°—π

(k) π‚¬∫“¬°“√®—¥°“√‡¡◊ËÕ¡’¢âÕ√âÕß‡√’¬π

(l) π‚¬∫“¬∑∫∑«π°“√∫√‘À“√®—¥°“√∑’Ë¡’°“√ªØ‘∫—µ‘„π√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

(m) π‚¬∫“¬°“√§—¥‡≈◊Õ° ®—¥∑” ·≈–Õπÿ¡—µ‘°√–∫«π°“√µ√«®«‘‡§√“–Àå

(n) π‚¬∫“¬„π°“√®—¥°“√°—∫º≈°“√∑¥ Õ∫∑’Ë‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥

(o) π‚¬∫“¬°“√®—¥À“ “√¡“µ√∞“π·≈–«— ¥ÿÕâ“ßÕ‘ß

(p) π‚¬∫“¬°“√‡¢â“√à«¡°“√∑¥ Õ∫§«“¡™”π“≠ °“√ªØ‘∫—µ‘ß“π√à«¡°—π√–À«à“ßÀâÕßªØ‘∫—µ‘°“√

·≈–°“√ª√–‡¡‘π ¡√√∂π– (π‚¬∫“¬„π¢âÕπ’ÈÕ“®®”‡ªìπ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ

‡¿ —™¿—≥±å√–¥—∫™“µ‘ ·µà‰¡à®”‡ªìπ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√ Õ◊Ëπ) ·≈–

(q) π‚¬∫“¬°“√§—¥‡≈◊Õ°ºŸâ®—¥„Àâ¡’°“√∫√‘°“√·≈–ºŸâ„Àâ∫√‘°“√

2.3 ÀâÕßªØ‘∫—µ‘°“√§«√®—¥∑” ¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π (SOPs) ÷Ëß‰¥â√—∫°“√Õπÿ¡—µ‘·≈â«„π√Ÿª·∫∫‡Õ° “√

‚¥¬∂◊ÕªØ‘∫—µ‘ ·≈–§ß‰«â ‚¥¬√–∫ÿÀ≈—°ªØ‘∫—µ‘¥â“π°“√∫√‘À“√®—¥°“√·≈–¥â“π«‘™“°“√µà“ßÊ ‰¥â·°à

(a) À≈—°ªØ‘∫—µ‘¥â“π∫ÿ§≈“°√ √«¡∂÷ß ¢âÕ°”Àπ¥¥â“π§ÿ≥ ¡∫—µ‘ °“√Ωñ°Õ∫√¡ °“√·µàß°“¬ ·≈–

ÿ¢Õπ“¡—¬

(b) °“√§«∫§ÿ¡°“√‡ª≈’Ë¬π·ª≈ß

(c) °“√µ√«®µ‘¥µ“¡¿“¬„π

(d) °“√®—¥°“√¢âÕ√âÕß‡√’¬π

(e) °“√ª√–°“»„™â·≈–°“√∑«π Õ∫¡“µ√°“√·°â‰¢·≈–ªÑÕß°—π

(f) °“√®—¥´◊ÈÕ·≈–µ√«®√—∫«— ¥ÿ (‡™àπ µ—«Õ¬à“ß ·≈– “√∑”ªØ‘°‘√‘¬“)



26

(g) the procurement, preparation and control of reference substances and referencematerials (8);

(h) the internal labelling, quarantine and storage of materials;

(i) the qualification of equipment (11);

(j) the calibration of equipment;

(k) preventive maintenance and verification of instruments and equipment;

(l) sampling, if performed by the laboratory, and visual inspection;

(m) the testing of samples with descriptions of the methods and equipment used;

(n) atypical and OOS results;

(o) validation of analytical procedures;

(p) cleaning of laboratory facilities, including bench tops, equipment, work stations,clean rooms (aseptic suites) and glassware;

(q) monitoring of environmental conditions, e.g. temperature and humidity;

(r) monitoring storage conditions;

(s) disposal of reagents and solvent samples; and

(t) safety measures.

2.4 The activities of the laboratory should be systematically and periodically audited(internally and, where appropriate, by external audits or inspections) to verify compliance withthe requirements of the quality management system and to apply corrective and preventive actions,if necessary. The audits should be carried out by trained and qualified personnel, who areindependent of the activity to be audited. The quality manager is responsible for planningand organizing internal audits addressing all elements of the quality management system. Suchaudits should be recorded, together with details of any corrective and preventive action taken.

2.5 Management review of quality issues should be regularly undertaken (at leastannually), including:

(a) reports on internal and external audits or inspections and any follow-up requiredto correct any deficiencies;

(b) the outcome of investigations carried out as a result of complaints received,doubtful (atypical) or aberrant results reported in collaborative trials and/orproficiency tests; and

(c) corrective actions applied and preventive actions introduced as a result ofthese investigations.


27À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(g) °“√®—¥À“ °“√‡µ√’¬¡ ·≈–°“√§«∫§ÿ¡ “√¡“µ√∞“π·≈–«— ¥ÿÕâ“ßÕ‘ß (8)

(h) °“√µ‘¥©≈“° °“√°—°°—π ·≈–‡°Á∫√—°…“«— ¥ÿ

(i) §ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ (11)

(j) °“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ

(k) °“√∫”√ÿß√—°…“ ·≈–°“√∑«π Õ∫‡§√◊ËÕß¡◊Õ«—¥·≈–‡§√◊ËÕß¡◊Õµà“ßÊ

(l) °“√ ÿà¡µ—«Õ¬à“ß „π°√≥’∑’Ë∑”°“√ ÿà¡‚¥¬ÀâÕßªØ‘∫—µ‘°“√ ·≈–°“√ —ß‡°µ¥â«¬µ“

(m) °“√µ√«®«‘‡§√“–Àåµ—«Õ¬à“ß æ√âÕ¡¥â«¬«‘∏’°“√·≈–‡§√◊ËÕß¡◊Õ∑’Ë„™â

(n) °√≥’∑’Ëº≈°“√∑¥ Õ∫¡’§«“¡º‘¥ª°µ‘À√◊Õ‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥

(o) °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå

(p) °“√∑”§«“¡ –Õ“¥‡§√◊ËÕß¡◊Õ‡§√◊ËÕß„™âµà“ßÊ ¿“¬„πÀâÕßªØ‘∫—µ‘°“√ ´÷Ëß√«¡∂÷ß ‚µä–ªØ‘∫—µ‘°“√

‡§√◊ËÕß¡◊Õ ∫√‘‡«≥∑’ËªØ‘∫—µ‘ß“π ÀâÕßª√“»®“°‡™◊ÈÕ ·≈–‡§√◊ËÕß·°â«

(q) °“√‡ΩÑ“µ‘¥µ“¡ ¿“«–·«¥≈âÕ¡„πÀâÕßªØ‘∫—µ‘°“√ ‡™àπ Õÿ≥À¿Ÿ¡‘·≈–§«“¡™◊Èπ

(r) °“√‡ΩÑ“µ‘¥µ“¡ ¿“«–°“√‡°Á∫√—°…“

(s) °“√°”®—¥ “√∑”ªØ‘°‘√‘¬“ µ—«∑”≈–≈“¬ ·≈–µ—«Õ¬à“ß ·≈–

(t) ¡“µ√°“√¥â“π§«“¡ª≈Õ¥¿—¬

2.4 °‘®°√√¡¢ÕßÀâÕßªØ‘∫—µ‘°“√§«√‰¥â√—∫°“√µ√«®µ‘¥µ“¡Õ¬à“ß‡ªìπ√–∫∫µ“¡√–¬–‡«≈“ (°“√µ√«®

µ‘¥µ“¡¿“¬„π·≈–À“°‡ªìπ‰ª‰¥â§«√¡’°“√µ√«®µ‘¥µ“¡‚¥¬Àπà«¬ß“π¿“¬πÕ°À√◊Õ¡’ºŸâµ√«® Õ∫) ‡æ◊ËÕ∑«π Õ∫

«à“°“√¥”‡π‘πß“πµà“ßÊ ¢ÕßÀâÕßªØ‘∫—µ‘°“√¬—ß§ß‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥¢Õß√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

·≈– “¡“√∂¥”‡π‘π°“√ªÑÕß°—π·≈–·°â‰¢ªí≠À“∑’Ë‡°‘¥‰¥â §«√¡’°“√µ√«®µ‘¥µ“¡‚¥¬∫ÿ§≈“°√∑’Ë‰¥â√—∫°“√Õ∫√¡

·≈–¡’§ÿ≥ ¡∫—µ‘‡À¡“– ¡´÷Ëß‡ªìπÕ‘ √–®“°°‘®°√√¡∑’Ë∑”°“√µ√«®µ‘¥µ“¡ ‚¥¬„ÀâºŸâ®—¥°“√¥â“π§ÿ≥¿“æ‡ªìπ

ºŸâ√—∫º‘¥™Õ∫„π°“√«“ß·ºπ·≈–®—¥√–∫∫°“√µ√«® Õ∫¿“¬„π ‡æ◊ËÕµ√«® Õ∫Õß§åª√–°Õ∫¢Õß√–∫∫∫√‘À“√

®—¥°“√¥â“π§ÿ≥¿“æ∑—ÈßÀ¡¥·≈–§«√¡’°“√‡°Á∫∫—π∑÷°¢âÕ¡Ÿ≈°“√µ√«®µ‘¥µ“¡¥—ß°≈à“«√«¡∑—Èß√“¬≈–‡Õ’¬¥

‡°’Ë¬«°—∫°“√ªÑÕß°—π·≈–·°â‰¢ªí≠À“∑’Ë‡°‘¥¢÷Èπ¥â«¬

2.5 §«√®—¥„Àâ¡’°“√∑∫∑«π°“√∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æÕ¬à“ß ¡Ë”‡ ¡Õ (Õ¬à“ßπâÕ¬ 1 §√—ÈßµàÕªï)

´÷Ëß√«¡∂÷ß

(a) √“¬ß“πº≈°“√µ√«®µ‘¥µ“¡À√◊Õ°“√µ√« Õ∫¿“¬„π·≈–®“°Àπà«¬ß“π¿“¬πÕ°·≈–°“√µ‘¥µ“¡

º≈°“√·°â‰¢¢âÕ∫°æ√àÕßµà“ßÊ

(b) º≈°“√¥”‡π‘π°“√‡¡◊ËÕ‰¥â√—∫¢âÕ√âÕß‡√’¬π·≈–º≈°“√µ√«®«‘‡§√“–Àå∑’Ëπà“ ß —¬À√◊Õ‡∫’Ë¬ß‡∫π®“°

¢âÕ°”Àπ¥∑’Ë√“¬ß“π®“°°“√ªØ‘∫—µ‘ß“π√à«¡°—π√–À«à“ßÀâÕßªØ‘∫—µ‘°“√·≈–/À√◊Õ®“°°“√∑¥ Õ∫

§«“¡™”π“≠ ·≈–

(c) «‘∏’∑’Ëπ”¡“¥”‡π‘π°“√·°â‰¢·≈–¢âÕ‡ πÕ·π–‡æ◊ËÕ°“√ªÑÕß°—π



28

3. Control of documentation

3.1 Documentation is an essential part of the quality management system. The laboratoryshould establish and maintain procedures to control and review all documents (both internallygenerated and from external sources) that form part of the quality documentation. A masterlist identifying the current version status and distribution of documents should be establishedand readily available.

3.2 The procedures should ensure that:

(a) each document, whether a technical or a quality document, has a unique identifier,version number and date of implementation;

(b) appropriate, authorized SOPs are available at the relevant locations, e.g. nearinstruments;

(c) documents are kept up to date and reviewed as required;

(d) any invalid document is removed and replaced with the authorized, reviseddocument with immediate effect;

(e) a revised document includes references to the previous document;

(f) old, invalid documents are retained in the archives to ensure traceability of theevolution of the procedures; any copies are destroyed;

(g) all relevant staff are trained for the new and revised SOPs; and

(h) quality documentation, including records, is retained for a minimum of five years.

3.3 A system of change control should be in place to inform staff of new and revisedprocedures. The system should ensure that :

(a) revised documents are prepared by the initiator, or a person who performs thesame function, reviewed and approved at the same level as the original documentand subsequently released by the quality manager (quality unit); and

(b) staff acknowledge by a signature that they are aware of applicable changes andtheir date of implementation.

4. Records

4.1 The laboratory should establish and maintain procedures for the identification,collection, indexing, retrieval, storage, maintenance and disposal of and access to all qualityand technical/scientific records.


29À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

3. °“√§«∫§ÿ¡‡Õ° “√

3.1 °“√§«∫§ÿ¡‡Õ° “√‡ªìπ à«πÀπ÷Ëß∑’Ë¡’§«“¡ ”§—≠„π°“√∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ ÀâÕßªØ‘∫—µ‘°“√

§«√®—¥∑”·≈–√—°…“‰«â ´÷Ëß¢—ÈπµÕπ°“√¥”‡π‘πß“π„π°“√§«∫§ÿ¡·≈–∑∫∑«π‡Õ° “√µà“ßÊ ∑—ÈßÀ¡¥ ∑’Ë‡ªìπ

à«πª√–°Õ∫¢Õß‡Õ° “√§ÿ≥¿“æ (∑—Èß∑’Ë®—¥∑”¢÷Èπ‡Õß¿“¬„π·≈–¡“®“°¿“¬πÕ°) §«√®—¥∑”·≈–¡’„Àâæ√âÕ¡¢Õß

∫—≠™’√“¬™◊ËÕ‡Õ° “√∑’Ë∫àß∫Õ°«à“ ∂“π–∑’Ë‡ªìπªí®®ÿ∫—π¢Õß‡Õ° “√·≈–°“√·®°®à“¬

3.2 ¢—ÈπµÕπ¥”‡π‘π°“√ §«√¡—Ëπ„®«à“

(a) ‡Õ° “√·µà≈–©∫—∫‰¡à«à“®–‡ªìπ‡Õ° “√¥â“π«‘™“°“√À√◊Õ¥â“π§ÿ≥¿“æ §«√¡’°“√∫àß™’ÈÕ¬à“ß‡ªìπ

√–∫∫ §√—Èß∑’Ë®—¥∑” ·≈–«—π‡¥◊Õπªï∑’Ë®—¥∑”‡Õ° “√‡ √Á® ¡∫Ÿ√≥åæ√âÕ¡„™â

(b) ¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π„¥Ê ∑’ËÕπÿ¡—µ‘„™â §«√Õ¬Ÿà„π∫√‘‡«≥∑’Ë‡°’Ë¬«¢âÕß°—∫°“√ªØ‘∫—µ‘ß“π

“¡“√∂À¬‘∫¡“„™â‰¥âßà“¬ ‡™àπ „°≈â‡§√◊ËÕß¡◊Õ

(c) ¡’°“√ª√—∫ª√ÿß‡Õ° “√„Àâ‡ªìπªí®®ÿ∫—π·≈–¡’°“√∑∫∑«π‡Õ° “√Õ¬à“ß ¡Ë”‡ ¡Õ

(d) ‡Õ° “√∑’Ë‰¡à„™â·≈â« „Àâπ”ÕÕ°‰ª∑—π∑’·≈–π”‡Õ° “√©∫—∫ª√—∫ª√ÿß·°â‰¢·≈–Õπÿ¡—µ‘·≈â«¡“·∑π∑’Ë

(e) ‡Õ° “√©∫—∫ª√—∫ª√ÿß·°â‰¢¡’°“√Õâ“ßÕ‘ß∂÷ß‡Õ° “√‡¥‘¡

(f) ‡Õ° “√©∫—∫‡°à“À√◊Õ©∫—∫∑’Ë‰¡à„™â·≈â« „Àâ‡°Á∫√—°…“µâπ©∫—∫‰«â ‡æ◊ËÕ„Àâ “¡“√∂ Õ∫°≈—∫„π‡√◊ËÕß

«‘«—≤π“°“√¢Õß¢—ÈπµÕπ°“√ªØ‘∫—µ‘ß“π‰¥â à«π ”‡π“§Ÿà©∫—∫„Àâ∑”≈“¬∑—ÈßÀ¡¥

(g) ºŸâªØ‘∫—µ‘ß“π∑ÿ°§π∑’Ë‡°’Ë¬«¢âÕß‰¥â√—∫°“√Ωñ°Õ∫√¡ ”À√—∫¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π©∫—∫„À¡à

·≈–©∫—∫ª√—∫ª√ÿß·°â‰¢ ·≈–

(h) ‡Õ° “√§ÿ≥¿“æ √«¡∂÷ß∫—π∑÷°µà“ßÊ ‰«âÕ¬à“ßπâÕ¬ 5 ªï

3.3 §«√¡’√–∫∫§«∫§ÿ¡°“√‡ª≈’Ë¬π·ª≈ß‡Õ° “√ ‡æ◊ËÕ„ÀâºŸâªØ‘∫—µ‘ß“π∑√“∫‡°’Ë¬«°—∫¢—ÈπµÕπ°“√¥”‡π‘πß“π

„À¡àÀ√◊Õ∑’Ëª√—∫ª√ÿß·°â‰¢ ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“

(a) ‡Õ° “√©∫—∫ª√—∫ª√ÿß·°â‰¢ ®—¥∑”‚¥¬ºŸâ®—¥∑”‡Õ° “√µâπ©∫—∫ À√◊Õ∫ÿ§§≈ ÷ËßªØ‘∫—µ‘Àπâ“∑’Ë

„πµ”·Àπàß‡¥’¬«°—π ·≈–‰¥â√—∫°“√∑∫∑«π ·≈–Õπÿ¡—µ‘„π√–¥—∫‡¥’¬«°—π‡™àπ‡¥’¬«°—∫‡Õ° “√

µâπ©∫—∫ ·≈– àßÕÕ°‰ª‚¥¬ºŸâ®—¥°“√¥â“π§ÿ≥¿“æ (Àπà«¬ªØ‘∫—µ‘ß“π¥â“π§ÿ≥¿“æ) ·≈–

(b) ºŸâªØ‘∫—µ‘ß“π≈ßπ“¡√—∫∑√“∫°“√‡ª≈’Ë¬π·ª≈ß‡Õ° “√ ‡æ◊ËÕ· ¥ß«à“‰¥â√—∫∑√“∫‡°’Ë¬«°—∫‡√◊ËÕß

∑’Ë‡ª≈’Ë¬π·ª≈ß·≈–«—π‡¥◊Õπªï∑’Ë®—¥∑” ‡Õ° “√‡ √Á® ¡∫Ÿ√≥åæ√âÕ¡„™â

4. ∫—π∑÷°

4.1 ÀâÕßªØ‘∫—µ‘°“√§«√¡’°“√®—¥∑”·≈–√—°…“‰«â´÷Ëß¢—ÈπµÕπ°“√¥”‡π‘πß“π„π°“√™’È∫àß °“√‡°Á∫√«∫√«¡

°“√®—¥∑”¥—™π’‡Õ° “√ °“√‡√’¬°°≈—∫¡“„™â °“√‡°Á∫√—°…“ °“√¥Ÿ·≈√—°…“ °“√∑”≈“¬·≈–°“√‡¢â“∂÷ß ∑—Èß∫—π∑÷°

¥â“π§ÿ≥¿“æ ¥â“π«‘™“°“√ ¥â“π«‘∑¬“»“ µ√å∑—ÈßÀ¡¥



30

4.2 All original observations, including calculations and derived data, calibration, validationand verification records and final results, should be retained on record for an appropriate periodof time in accordance with national regulations and, if applicable, contractual arrangements,whichever is longer. The records should include the data recorded in the analytical worksheet bythe technician or analyst on consecutively numbered pages with references to the appendicescontaining the relevant recordings, e.g. chromatograms and spectra. The records for each testshould contain sufficient information to permit the tests to be repeated and/or the resultsto be recalculated, if necessary. The records should include the identity of the personnel involvedin the sampling, preparation and testing of the samples. The records of samples to be usedin legal proceedings should be kept according to the legal requirements applicable to them.

Note: The generally accepted retention period of shelf-life plus one year for apharmaceutical product on the market and 15 years for an investigational product is recommended,unless national regulations are more stringent or contractual arrangements do not require otherwise.

4.3 All quality and technical/scientific records (including analytical test reports, certificatesof analysis and analytical worksheets) should be legible, readily retrievable, stored and retainedwithin facilities that provide a suitable environment that will prevent modification, damage ordeterioration and/or loss. The conditions under which all original records are stored should be suchas to ensure their security and confidentiality and access to them should be restrictedto authorized personnel. Electronic storage and signatures may also be employed but withrestricted access and in conformance with requirements for electronic records (12 - 16).

4.4 Quality management records should include reports from internal (and external ifperformed) audits and management reviews, as well as records of all complaints and theirinvestigations, including records of possible corrective and preventive actions.

5. Data-processing equipment

5.1 Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortiethreport of the WHO Expert Committee on Specifications for Pharmaceutical Preparations:Supplementary guidelines in good manufacturing practice: validation. Validation of computerizedsystems (12).

5.2 For computers, automated tests or calibration equipment, and the collection,processing, recording, reporting, storage or retrieval of test and/or calibration data, the laboratoryshould ensure that:


31À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

4.2 ∫—π∑÷°µà“ßÊ ‡°’Ë¬«°—∫ ‘Ëß∑’Ë —ß‡°µæ∫‡∫◊ÈÕßµâπ √«¡∂÷ß¢âÕ¡Ÿ≈°“√§”π«≥ ·≈–¢âÕ¡Ÿ≈∑’Ë«‘‡§√“–Àå

(derived data) ∫—π∑÷°°“√ Õ∫‡∑’¬∫ ∫—π∑÷°°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ∫—π∑÷°°“√∑«π Õ∫ ·≈–º≈≈—æ∏å∑’Ë‰¥â

§«√¡’°“√‡°Á∫∫—π∑÷°‰«â¿“¬„π™à«ß√–¬–‡«≈“∑’Ë°ÆÀ¡“¬°”Àπ¥ À√◊Õµ“¡¢âÕµ°≈ß∑’Ë‰¥â∑”‰«â ¢÷Èπ°—∫«à“√–¬–‡«≈“„¥

®–¬“«°«à“ ‚¥¬À¡“¬√«¡∂÷ß¢âÕ¡Ÿ≈∑’Ë‰¥â√—∫°“√∫—π∑÷°≈ß„π·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå ´÷Ëßπ—°«™“°“√À√◊Õ

π—°«‘‡§√“–Àå‡ªìπºŸâ∫—π∑÷°‚¥¬‡√’¬ß≈”¥—∫µ“¡‡≈¢∑’ËÀπâ“¢Õß‡Õ° “√ æ√âÕ¡¿“§ºπ«°‡°’Ë¬«°—∫∫—π∑÷°∑’Ë‡°’Ë¬«¢âÕß ‡™àπ

chromatograms ·≈– spectra ‡ªìπµâπ ¢âÕ¡Ÿ≈¢Õß°“√µ√«®«‘‡§√“–Àå·µà≈–§√—Èß∑’Ë∫—π∑÷°‰«â§«√¡’¢âÕ¡Ÿ≈‡æ’¬ßæÕ

∑’Ë®–Õπÿ≠“µ„Àâ«‘‡§√“–Àå È” ·≈–/À√◊Õ “¡“√∂§”π«≥º≈°“√«‘‡§√“–Àå È”‰¥â „π°√≥’∑’Ë®”‡ªìπµâÕßµ√«®«‘‡§√“–Àå È”

πÕ°®“°π’È∫—π∑÷°§«√√–∫ÿ√“¬™◊ËÕ¢Õß∫ÿ§≈“°√∑’Ë‡°’Ë¬«¢âÕß„π¢—ÈπµÕπ°“√ ÿà¡µ—«Õ¬à“ß °“√‡µ√’¬¡µ—«Õ¬à“ß ·≈–

°“√µ√«®«‘‡§√“–Àåµ—«Õ¬à“ß ∫—π∑÷°°’Ë¬«°—∫µ—«Õ¬à“ß∑’Ë„™â„π°“√¥”‡π‘π°“√∑“ß°ÆÀ¡“¬ §«√®—¥‡°Á∫µ“¡À≈—°‡°≥±å

∑’Ë°ÆÀ¡“¬°”Àπ¥

À¡“¬‡Àµÿ: ‚¥¬∑—Ë«‰ª √–¬–‡«≈“∑’Ë°”Àπ¥ ”À√—∫‡¿ —™¿—≥±å∑’Ë®”Àπà“¬„πµ≈“¥ §◊Õ Õ“¬ÿ°“√„™â¢Õß¬“

∫«°Õ’° 1 ªï ·≈– ”À√—∫º≈‘µ¿—≥±å∑’ËµâÕß¥”‡π‘π°“√µ“¡°ÆÀ¡“¬ §◊Õ 15 ªï ∂â“‰¡à¡’°“√‡ª≈’Ë¬π·ª≈ß‚¥¬

Õß§å°√§«∫§ÿ¡√–¥—∫™“µ‘À√◊Õ‰¡à¡’°“√µ°≈ß‡ªìπÕ¬à“ßÕ◊Ëπ

4.3 ∫—π∑÷°¢âÕ¡Ÿ≈¥â“π§ÿ≥¿“æ·≈–¥â“π«‘™“°“√/¥â“π«‘∑¬“»“ µ√å∑—ÈßÀ¡¥ (√«¡∑—Èß√“¬ß“πº≈«‘‡§√“–Àå

„∫√—∫√Õßº≈«‘‡§√“–Àå ·≈–·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå) §«√Õà“πßà“¬ “¡“√∂‡√’¬°¥Ÿ‰¥â ·≈–‡°Á∫√—°…“

„π ¿“«–·«¥≈âÕ¡∑’ËªÑÕß°—π°“√¥—¥·ª≈ß §«“¡‡ ’¬À“¬ °“√‡ ◊ËÕ¡ ¿“æ ·≈–/À√◊Õ°“√ Ÿ≠À“¬ ¿“«–°“√

‡°Á∫√—°…“∫—π∑÷°µâπ©∫—∫µà“ßÊ §«√·πà„®«à“¡’§«“¡ª≈Õ¥¿—¬·≈–‡ªìπ§«“¡≈—∫ ·≈–°“√‡¢â“∂÷ß¢âÕ¡Ÿ≈µâÕß∑”‚¥¬

ºŸâ´÷Ëß‰¥â√—∫¡Õ∫Õ”π“®„Àâ∑”°“√‡√’¬°¥Ÿ¢âÕ¡Ÿ≈‰¥â‡∑à“π—Èπ Õ“®„™â°“√‡°Á∫∫—π∑÷° ·≈–°“√≈ßπ“¡∑“ßÕ‘‡≈Á°∑√Õπ‘° å

·µà°“√‡¢â“∂÷ß¢âÕ¡Ÿ≈µâÕß¡’°“√§«∫§ÿ¡Õ¬à“ß‡¢â¡ß«¥·≈– Õ¥§≈âÕß°—∫¢âÕ°”Àπ¥¢Õß°“√‡°Á∫∫—π∑÷°¢âÕ¡Ÿ≈

∑“ßÕ‘‡≈Á°∑√Õπ‘° å (12 - 16)

4.4 ∫—π∑÷°°“√∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ §«√√«¡∂÷ß√“¬ß“π®“°°“√µ√«®µ‘¥µ“¡¿“¬„π·≈–

°“√µ√«®µ‘¥µ“¡‚¥¬Àπà«¬ß“π¿“¬πÕ° (∂â“¡’) ‡™àπ‡¥’¬«°—∫¢âÕ¡Ÿ≈°“√∫—π∑÷°¢âÕ√âÕß‡√’¬π·≈–°“√‰µà «π √«¡∑—Èß

¢âÕ¡Ÿ≈°“√∫—π∑÷°°“√·°â‰¢¢âÕ∫°æ√àÕß·≈–«‘∏’°“√ªÑÕß°—π°“√‡°‘¥¢âÕ∫°æ√àÕß∑’Ë “¡“√∂ªØ‘∫—µ‘‰¥â

5. ‡§√◊ËÕß¡◊Õ∑’Ë„™â„π°“√ª√–¡«≈º≈¢âÕ¡Ÿ≈

5.1 √“¬≈–‡Õ’¬¥§”·π–π”‡°’Ë¬«°—∫‡§√◊ËÕß¡◊Õ∑’Ë„™â„π°“√ª√–¡«≈º≈¢âÕ¡Ÿ≈ “¡“√∂»÷°…“‡æ‘Ë¡‡µ‘¡‰¥â®“°

Appendix 5 to Annex 4 „π√“¬ß“π°“√ª√–™ÿ¡§≥–ºŸâ‡™’Ë¬«™“≠Õß§å°“√Õπ“¡—¬‚≈°¥â“π¢âÕ°”Àπ¥‡¿ —™¿—≥±å

§√—Èß∑’Ë 40 ·π«∑“ß«‘∏’°“√ªØ‘∫—µ‘∑’Ë¥’„π°“√º≈‘µ©∫—∫‡æ‘Ë¡‡µ‘¡ «à“¥â«¬‡√◊ËÕß °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß

√–∫∫§Õ¡æ‘«‡µÕ√å (12)

5.2 ”À√—∫§Õ¡æ‘«‡µÕ√å ‡§√◊ËÕß¡◊Õ„™â„π°“√µ√«® Õ∫À√◊Õ Õ∫‡∑’¬∫·∫∫Õ—µ‚π¡—µ‘ ·≈–°“√‡°Á∫√«∫√«¡

°“√ª√–¡«≈º≈ °“√∫—π∑÷° °“√√“¬ß“π °“√‡°Á∫√—°…“·≈–°“√‡√’¬°°≈—∫¡“„™â¢Õß¢âÕ¡Ÿ≈°“√∑¥ Õ∫ ·≈–/À√◊Õ

¢âÕ¡Ÿ≈°“√ Õ∫‡∑’¬∫ ÀâÕßªØ‘∫—µ‘°“√§«√¡—Ëπ„®«à“



32

(a) computer software developed by the user is documented in sufficient detail andappropriately validated or verified as being suitable for use;

(b) procedures are established and implemented for protecting the integrity of data.Such procedures should include, but are not limited to, measures to ensure theintegrity and confidentiality of data entry or collection and the storage, transmissionand processing of data. In particular, electronic data should be protected fromunauthorized access and an audit trail of any amendments should be maintained;

(c) computers and automated equipment are maintained so as to function properly andare provided with the environmental and operating conditions necessary to ensurethe integrity of test and calibration data;

(d) procedures are established and implemented for making, documenting andcontrolling changes to information stored in computerized systems; and

(e) electronic data should be backed up at appropriate regular intervals according toa documented procedure. Backed-up data should be retrievable and stored in sucha manner as to prevent data loss.

Note: For further guidance on validation of data-processing equipment, refer todocuments published by the International Society for Pharmaceutical Engineering (13, 14),US Food and Drug Administration (15), European Commission (16) and the Official MedicinesControl Laboratories Network of the Council of Europe (17).

6. Personnel

6.1 The laboratory should have sufficient personnel with the necessary education, training,technical knowledge and experience for their assigned functions.

6.2 The technical management should ensure the competence of all personnel operatingspecific equipment, instruments or other devices, who are performing tests and/or calibrations,validations or verifications. Their duties also involve the evaluation of results as well as signinganalytical test reports and certificates of analysis (see Part three, sections 18.7-18.11 and 19).

6.3 Staff undergoing training should be appropriately supervised and should be assessedon completion of the training. Personnel performing specific tasks should be appropriatelyqualified in terms of their education, training and experience, as required.


33À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(a) §Õ¡æ‘«‡µÕ√å´Õø·«√å´÷ËßºŸâ„™âß“πæ—≤π“¢÷Èπ §«√®—¥∑”‡ªìπ‡Õ° “√∑’Ë¡’√“¬≈–‡Õ’¬¥Õ¬à“ß

‡æ’¬ßæÕ ·≈–‰¥â√—∫°“√µ√«® Õ∫À√◊Õ°“√∑«π Õ∫∑’Ë‡À¡“– ¡«à“‡À¡“– ”À√—∫°“√„™âß“π

(b) ¡’°“√®—¥∑”¢—ÈπµÕπ°“√¥”‡π‘πß“π·≈–π”‰ªªØ‘∫—µ‘ ‡æ◊ËÕªÑÕß°—π§«“¡ ¡∫Ÿ√≥å¢Õß¢âÕ¡Ÿ≈ ÷Ëß

Õ¬à“ßπâÕ¬§«√√«¡∂÷ß§«“¡ ¡∫Ÿ√≥å·≈–ª°ªî¥„π°“√∫—π∑÷°À√◊Õ√«∫√«¡·≈–°“√‡°Á∫√—°…“

¢âÕ¡Ÿ≈ °“√ àßºà“π ·≈–°“√ª√–¡«≈¢âÕ¡Ÿ≈ ‚¥¬‡©æ“–Õ¬à“ß¬‘Ëß¢âÕ¡Ÿ≈∑“ßÕ‘‡≈Á°∑√Õπ‘° å

´÷Ëß§«√ªÑÕß°—π¡‘„Àâ∫ÿ§§≈∑’Ë‰¡à‰¥â√—∫¡Õ∫Õ”π“®‡¢â“∂÷ß‰¥â ·≈–§«√¡’°“√µ√«® Õ∫·≈–ª√—∫ª√ÿß

∞“π¢âÕ¡Ÿ≈Õ¬Ÿà‡ ¡Õ

(c) §Õ¡æ‘«‡µÕ√å·≈–‡§√◊ËÕß¡◊ÕÕ—µ‚π¡—µ‘µà“ßÊ §«√‰¥â√—∫°“√∫”√ÿß√—°…“„Àâ “¡“√∂„™âß“π‰¥âÕ¬à“ß

‡À¡“– ¡·≈–®—¥„ÀâÕ¬Ÿà„π ¿“«–·«¥≈âÕ¡·≈– ¿“«–°“√∑”ß“π∑’Ë®”‡ªìπ∑’Ë®–∑”„Àâ‡™◊ËÕ¡—Ëπ

„π§«“¡ ¡∫Ÿ√≥å¢Õß°“√∑¥ Õ∫·≈–¢âÕ¡Ÿ≈°“√ Õ∫‡∑’¬∫

(d) ¡’°“√®—¥∑”¢—ÈπµÕπ°“√¥”‡π‘πß“π·≈–π”‰ªªØ‘∫—µ‘ ‡æ◊ËÕ°“√®—¥∑”¢âÕ¡Ÿ≈ °“√®—¥∑”‡Õ° “√

·≈–§«∫§ÿ¡°“√‡ª≈’Ë¬π·ª≈ß¢âÕ¡Ÿ≈∑’Ë‡°Á∫‰«â„π√–∫∫§Õ¡æ‘«‡µÕ√å ·≈–

(e) §«√¡’°“√‡°Á∫ ”√Õß (back up) ¢âÕ¡Ÿ≈∑“ßÕ‘‡≈Á°∑√Õπ‘° å„π√–¬–‡«≈“∑’Ë°”Àπ¥µ“¡√–∫∫

°“√®—¥‡°Á∫‡Õ° “√ ‚¥¬¢âÕ¡Ÿ≈∑’Ë‡°Á∫ ”√Õß‰«âπ’È§«√‡√’¬°°≈—∫¡“„™â‰¥â·≈–‰¥â√—∫°“√ªÑÕß°—π

°“√ Ÿ≠À“¬¢Õß¢âÕ¡Ÿ≈

À¡“¬‡Àµÿ: »÷°…“¢âÕ¡Ÿ≈‡æ‘Ë¡‡µ‘¡‰¥â®“°§Ÿà¡◊Õ°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß‡§√◊ËÕß¡◊Õª√–‡¡‘πº≈¢Õß

International Society for Pharmaceutical Engineering (13 - 14), U.S. Food and Drug Administration (15),

European Commission (16) ·≈– the Official Medicines Control Laboratories Network of the Council

of Europe (17)

6. ∫ÿ§≈“°√

6.1 ÀâÕßªØ‘∫—µ‘°“√§«√¡’®”π«π∫ÿ§≈“°√‡æ’¬ßæÕ∑’Ë¡’§«“¡√Ÿâ§«“¡ “¡“√∂ ‰¥â√—∫°“√Ωñ°Õ∫√¡·≈–¡’§«“¡√Ÿâ

¥â“π‡∑§π‘§‡©æ“–¥â“π ∑’Ë®”‡ªìπµàÕ°“√ªØ‘∫—µ‘ß“π ·≈–¡’ª√– ∫°“√≥å„πÀπâ“∑’Ë∑’Ë‰¥â√—∫¡Õ∫À¡“¬Õ¬à“ß‡æ’¬ßæÕ

6.2 ºŸâ∫√‘À“√®—¥°“√¥â“π«‘™“°“√ §«√¡—Ëπ„®«à“∫ÿ§≈“°√∑ÿ°§π∑’ËªØ‘∫—µ‘ß“π‡°’Ë¬«°—∫°“√∑¥ Õ∫·≈–/À√◊Õ

°“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß À√◊Õ°“√∑«π Õ∫ §«√¡’§«“¡√Ÿâ§«“¡ “¡“√∂„π°“√„™â

‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ∑’Ë„™â„π°“√ªØ‘∫—µ‘ß“π‡ªìπÕ¬à“ß¥’ ‚¥¬ºŸâªØ‘∫—µ‘ß“πµâÕß√—∫º‘¥™Õ∫Àπâ“∑’Ë

„π°“√ª√–‡¡‘πº≈°“√∑¥ Õ∫ √«¡∂÷ß≈ßπ“¡√—∫√Õß„π√“¬ß“πº≈°“√«‘‡§√“–Àå ·≈–„∫√—∫√Õßº≈°“√«‘‡§√“–Àå

(¥Ÿ à«π∑’Ë 3 ¢âÕ 18.7 - 18.11 ·≈– ¢âÕ 19)

6.3 ºŸâªØ‘∫—µ‘ß“π∑’ËÕ¬Ÿà„π√–À«à“ß°“√Ωñ° Õπß“π§«√‰¥â√—∫°“√§«∫§ÿ¡ß“πÕ¬à“ß‡À¡“– ¡ ·≈–§«√¡’

°“√ª√–‡¡‘π§«“¡√Ÿâ ‡¡◊ËÕ ‘Èπ ÿ¥°“√Ωñ° Õπß“π ∫ÿ§≈“°√∑’ËªØ‘∫—µ‘ß“πæ‘‡»…‡©æ“–¥â“π§«√¡’§ÿ≥ ¡∫—µ‘¥â“π°“√»÷°…“

°“√Ωñ°Õ∫√¡ ·≈–ª√– ∫°“√≥å„π°“√∑”ß“π„π√–¥—∫∑’Ë°”Àπ¥



34

6.4 The laboratory personnel should be permanently employed or under contract.The laboratory should ensure that additional technical and key support personnel who are undercontract are supervised and sufficiently competent and that their work is in accordance withthe quality management system.

6.5 The laboratory should maintain current job descriptions for all personnel involved intests and/or calibrations, validations and verifications. The laboratory should also maintain recordsof all technical personnel, describing their qualifications, training and experience.

6.6 The laboratory should have the following managerial and technical personnel:

(a) a head of laboratory (supervisor), who should have qualifications appropriate tothe position, with extensive experience in medicines analysis and laboratorymanagement in a pharmaceutical quality control laboratory in the regulatory sectoror in industry. The head of laboratory is responsible for the content of certificatesof analysis and analytical testing reports. This person is also responsible forensuring that:

(i) all key members of the laboratory staff have the requisite competence for therequired functions and their grades reflect their responsibilities,

(ii) the adequacy of existing staffing, management and training procedures isreviewed periodically,

(iii) the technical management is adequately supervised;

(b) the technical management who ensure that:

(i) procedures for performing calibration, verification and (re-) qualification ofinstruments, monitoring of environmental and storage conditions are inplace and are conducted as required,

(ii) regular in-service training programmes to update and extend the skills ofboth professionals and technicians are arranged,

(iii) the safekeeping of any materials subject to poison regulation or to the controlsapplied to narcotic and psychotropic substances (see Part one, section 7.12)kept in the workplace is under the supervision of an authorized person,

(iv) national pharmaceutical quality control laboratories regularly participate insuitable proficiency testing schemes and collaborative trials to assessanalytical procedures or reference substances;

(c) analysts, who should normally be graduates in pharmacy, analytical chemistry,microbiology or other relevant subjects, with the requisite knowledge, skills andability to adequately perform the tasks assigned to them by management andto supervise technical staff;


35À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

6.4 °“√®â“ßß“π∫ÿ§≈“°√ÀâÕßªØ‘∫—µ‘°“√ §«√‡ªìπ°“√®â“ß·∫∫ß“πª√–®” À√◊Õ®â“ßµ“¡ —≠≠“®â“ß ·≈–

§«√¡—Ëπ„®«à“∫ÿ§≈“°√¥â“π«‘™“°“√·≈–∫ÿ§≈“°√ π—∫ πÿπ∑’Ë ”§—≠∑’Ë®â“ß‰«â‡ªìπºŸâ¡’§«“¡√Ÿâ§«“¡ “¡“√∂∑’Ë‡æ’¬ßæÕ

µàÕ°“√ªØ‘∫—µ‘ß“π ·≈–°“√ªØ‘∫—µ‘ß“π¢Õß∫ÿ§≈“°√‡À≈à“π’È ‡ªìπ‰ªµ“¡√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ

6.5 ÀâÕßªØ‘∫—µ‘°“√§«√√—°…“‰«â ÷Ëß§”∫√√¬“¬≈—°…≥–ß“π∑’Ë‡ªìπªí®®ÿ∫—π ”À√—∫∫ÿ§≈“°√∑ÿ°§π∑’ËªØ‘∫—µ‘

ß“π‡°’Ë¬«¢âÕß°—∫°“√∑¥ Õ∫·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫

·≈–§«√¡’°“√®—¥∑”ª√–«—µ‘¢Õß∫ÿ§≈“°√ºŸâªØ‘∫—µ‘ß“π¥â“π«‘™“°“√∑ÿ°§π‚¥¬√«∫√«¡√“¬≈–‡Õ’¬¥‡°’Ë¬«°—∫§ÿ≥ ¡∫—µ‘

°“√Ωñ°Õ∫√¡·≈–ª√– ∫°“√≥å°“√∑”ß“π

6.6 ÀâÕßªØ‘∫—µ‘°“√§«√¡’∫ÿ§≈“°√¥â“π∫√‘À“√·≈–¥â“π«‘™“°“√´÷ËßªØ‘∫—µ‘ß“π„πµ”·Àπàß ¥—ßµàÕ‰ªπ’È:

(a) À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√ §«√¡’§ÿ≥ ¡∫—µ‘∑’Ë‡À¡“– ¡°—∫µ”·Àπàß ¡’§«“¡√Ÿâ·≈–ª√– ∫°“√≥åÕ¬à“ß

°«â“ß¢«“ß„π¥â“π°“√«‘‡§√“–Àå¬“·≈–°“√∫√‘À“√ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

„πÀπà«¬ß“π√—∞ À√◊Õ„π‚√ßß“πÕÿµ “À°√√¡ À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√¡’Àπâ“∑’Ë√—∫º‘¥™Õ∫„π

√“¬≈–‡Õ’¬¥¢Õß„∫√—∫√Õßº≈°“√«‘‡§√“–Àå ·≈–√“¬ß“πº≈°“√«‘‡§√“–Àå ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“

(i) ºŸâªØ‘∫—µ‘ß“πÀ≈—°∑—ÈßÀ¡¥„πÀâÕßªØ‘∫—µ‘°“√¡’§«“¡√Ÿâ§«“¡ “¡“√∂∑’Ë®”‡ªìπµàÕ°“√ªØ‘∫—µ‘ß“π

„πµ”·Àπàß¢Õßµπ ·≈–¡’√–¥—∫§«“¡√Ÿâ§«“¡ “¡“√∂ Õ¥§≈âÕß°—∫√–¥—∫§«“¡√—∫º‘¥™Õ∫

(ii) ®”π«π∫ÿ§≈“°√∑’Ë‡æ’¬ßæÕ ¢—ÈπµÕπ°“√Ωñ°Õ∫√¡·≈–°“√∫√‘À“√®—¥°“√‰¥â√—∫°“√∑∫∑«π

‡ªìπ√–¬–

(iii) ºŸâ®—¥°“√¥â“π«‘™“°“√‰¥â√—∫°“√°”°—∫¥Ÿ·≈Õ¬à“ß‡æ’¬ßæÕ

(b) ºŸâ∫√‘À“√¥â“π«‘™“°“√¡—Ëπ„®«à“

(i) ¡’¢—ÈπµÕπ°“√¥”‡π‘πß“π ”À√—∫°“√ Õ∫‡∑’¬∫ °“√∑«π Õ∫ ·≈–°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘

¢Õß‡§√◊ËÕß¡◊Õ °“√¥Ÿ·≈ ‘Ëß·«¥≈âÕ¡ ·≈– ¿“«–°“√‡°Á∫√—°…“ ·≈–¡’°“√¥”‡π‘π°“√µ“¡

§«“¡µâÕß°“√

(ii) ®—¥„Àâ¡’°“√ª√—∫ª√ÿß‚ª√·°√¡Ωñ°Õ∫√¡√–À«à“ß°“√ªØ‘∫—µ‘ß“π„Àâ∑—π ¡—¬·≈–¢¬“¬∑—°…–

∑“ß«‘™“™’æ ·≈–‡∑§π‘§°“√ªØ‘∫—µ‘ß“π

(iii) §«∫§ÿ¡°“√®—¥‡°Á∫«— ¥ÿ´÷Ëß®—¥Õ¬Ÿà„πª√–‡¿∑«—µ∂ÿ¡’æ‘… «—µ∂ÿ‡ æµ‘¥·≈–«—µ∂ÿÕÕ°ƒ∑∏‘ÏµàÕ®‘µ

·≈–ª√– “∑µ“¡°ÆÀ¡“¬ (¥Ÿ à«π∑’Ë 1 ¢âÕ 7.12) ‚¥¬«— ¥ÿ¥—ß°≈à“«§«√‰¥â√—∫°“√µ√«® Õ∫

·≈–°”°—∫¥Ÿ·≈‚¥¬‡®â“Àπâ“∑’Ë∑’Ë‰¥â√—∫¡Õ∫Õ”π“®

(iv) ‡¢â“√à«¡°“√∑¥ Õ∫§«“¡™”π“≠ ·≈–°“√∑¥ Õ∫√–À«à“ßÀâÕßªØ‘∫—µ‘°“√‡æ◊ËÕª√–‡¡‘π

°√–∫«π°“√µ√«®«‘‡§√“–ÀåÀ√◊Õ “√¡“µ√∞“π „π°√≥’∑’Ë‡ªìπÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡

§ÿ≥¿“æ‡¿ —™¿—≥±å√–¥—∫™“µ‘

(c) π—°«‘‡§√“–Àå´÷Ëß§«√‰¥â√—∫«ÿ≤‘°“√»÷°…“¥â“π‡¿ —™»“ µ√å ‡§¡’«‘‡§√“–Àå ®ÿ≈™’««‘∑¬“ À√◊Õ “¢“

Õ◊ËπÊ ∑’Ë‡°’Ë¬«¢âÕß ‚¥¬¡’§«“¡√Ÿâ§«“¡ “¡“√∂·≈–∑—°…–∑’Ë‡æ’¬ßæÕµàÕ°“√ªØ‘∫—µ‘ß“π∑’Ë‰¥â√—∫

¡Õ∫À¡“¬·≈– “¡“√∂∫√‘À“√·≈–§«∫§ÿ¡°“√ªØ‘∫—µ‘ß“π¢ÕßºŸâªØ‘∫—µ‘ß“π¥â“π‡∑§π‘§‰¥â



36

(d) technical staff, who should hold diplomas in their subjects awarded by technicalor vocational schools; and

(e) a quality manager (see Part one, section 1.3(j)).

7. Premises

7.1 The laboratory facilities are to be of a suitable size, construction and location.These facilities are to be designed to suit the functions and operations to be conducted in them.Rest and refreshment rooms should be separate from laboratory areas. Changing areas andtoilets should be easily accessible and appropriate for the number of users.

7.2 The laboratory facilities should have adequate safety equipment located appropriatelyand measures should be in place to ensure good housekeeping. Each laboratory should beequipped with adequate instruments and equipment, including work benches, work stations andfume hoods.

7.3 The environmental conditions, including lighting, energy sources, temperature,humidity and air pressure, are to be appropriate to the functions and operations to be performed.The laboratory should ensure that the environmental conditions are monitored, controlled anddocumented and do not invalidate the results or adversely affect the quality of the measurements.

7.4 Special precautions should be taken and, if necessary, there should be a separateand dedicated unit or equipment (e.g. isolator, laminar flow work bench) to handle, weighand manipulate highly toxic substances, including genotoxic substances. Procedures should bein place to avoid exposure and contamination.

7.5 Archive facilities should be provided to ensure the secure storage and retrieval ofall documents. The design and condition of the archives should be such as to protect thecontents from deterioration. Access to the archives should be restricted to designated personnel.

7.6 Procedures should be in place for the safe removal of types of waste includingtoxic waste (chemical and biological), reagents, samples, solvents and air filters.

7.7 Microbiological testing, if performed, should be contained in an appropriatelydesigned and constructed laboratory unit. For further guidance see the draft working documentWHO guideline on good practices for pharmaceutical microbiology laboratories (reference QAS/09.297).

7.8 If in vivo biological testing (e.g. rabbit pyrogen test) is included in the scope ofthe laboratory activities then the animal houses should be isolated from the other laboratory areaswith a separate entrance and air-conditioning system. The relevant guidance and regulations areto be applied (18).


37À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(d) ºŸâªØ‘∫—µ‘ß“π¥â“π‡∑§π‘§´÷Ëß§«√‰¥â√—∫«ÿ≤‘°“√»÷°…“„π√–¥—∫ª√–°“»π’¬∫—µ√«‘™“™’æ®“°

∂“∫—π‡∑§‚π‚≈¬’ À√◊Õ ∂“∫—πÕ“™’«–»÷°…“ ·≈–

(e) ºŸâ®—¥°“√¥â“π§ÿ≥¿“æ (¥Ÿ à«π∑’Ë 1 ¢âÕ 1.3 (j))

7. ∂“π∑’Ë

7.1 ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åµà“ßÊ „πÀâÕßªØ‘∫—µ‘°“√ §«√¡’¢π“¥ ‚§√ß √â“ß ·≈– ∂“π∑’Ë

µ—Èß∑’Ë‡À¡“– ¡ ‚¥¬‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åµà“ßÊ ‡À≈à“π’È §«√‰¥â√—∫°“√ÕÕ°·∫∫„Àâ‡À¡“– ¡°—∫

«—µ∂ÿª√– ß§å·≈–§«“¡ –¥«°„π°“√„™âß“π ÀâÕßæ—°‡®â“Àπâ“∑’Ë§«√·¬°‡ªìπ —¥ à«π®“°ÀâÕßªØ‘∫—µ‘°“√ ÀâÕß‡ª≈’Ë¬π

‡ ◊ÈÕºâ“·≈–ÀâÕßπÈ”§«√µ—ÈßÕ¬Ÿà∫√‘‡«≥∑’Ë‡¢â“ÕÕ°‰¥â –¥«° ·≈–¡’®”π«π∑’Ë‡À¡“– ¡°—∫®”π«πºŸâ„™âß“π

7.2 ÀâÕßªØ‘∫—µ‘°“√§«√µ‘¥µ—ÈßÕÿª°√≥åªÑÕß°—π§«“¡ª≈Õ¥¿—¬Õ¬à“ß‡æ’¬ßæÕ„π∫√‘‡«≥∑’Ë‡À¡“– ¡ ·≈–§«√

∑”°“√µ√«® Õ∫Õÿª°√≥åªÑÕß°—π§«“¡ª≈Õ¥¿—¬‡À≈à“π’ÈÕ¬à“ß ¡Ë”‡ ¡Õ ÀâÕßªØ‘∫—µ‘°“√·µà≈–ÀâÕß§«√¡’Õÿª°√≥å

‡§√◊ËÕß¡◊Õ·≈–‡§√◊ËÕß„™âÕ◊ËπÊ √«¡∑—Èß‚µä–∑”ß“π ®ÿ¥ªØ‘∫—µ‘ß“π ·≈–µŸâ¥Ÿ¥§«—π‡æ’¬ßæÕµàÕ°“√ªØ‘∫—µ‘ß“π

7.3 ¿“«–·«¥≈âÕ¡„πÀâÕßªØ‘∫—µ‘°“√ ´÷Ëß√«¡∂÷ß· ß «à“ß ·À≈àßæ≈—ßß“π Õÿ≥À¿Ÿ¡‘ §«“¡™◊Èπ ·≈–

§«“¡¥—πÕ“°“» §«√¡’§«“¡‡À¡“– ¡°—∫°“√ªØ‘∫—µ‘ß“π ·≈–§«√¡—Ëπ„®«à“ ¿“«–·«¥≈âÕ¡„πÀâÕßªØ‘∫—µ‘°“√π—Èπ

‰¥â√—∫°“√¥Ÿ·≈·≈–§«∫§ÿ¡‡ªìπÕ¬à“ß¥’ ‡æ◊ËÕ¡‘„Àâ¡’º≈°√–∑∫µàÕ§ÿ≥¿“æ¢Õß°“√µ√«®«‘‡§√“–Àå πÕ°®“°π’È§«√¡’

°“√®—¥∑”‡Õ° “√¢âÕ¡Ÿ≈°“√§«∫§ÿ¡ ¿“«–·«¥≈âÕ¡„πÀâÕßªØ‘∫—µ‘°“√¥â«¬

7.4 °“√À¬‘∫®—∫ ™—Ëß ·≈–°“√®—¥°“√„¥Ê ‡°’Ë¬«°—∫ “√∑’Ë¡’§«“¡‡ªìπæ‘… Ÿß ·≈– “√∑’Ë‡ªìπæ‘…∑“ß

æ—π∏ÿ°√√¡§«√„™â§«“¡√–¡—¥√–«—ß‡ªìπæ‘‡»… §«√¡’‡§√◊ËÕß¡◊ÕÕÿª°√≥å‡©æ“–‡æ◊ËÕªÑÕß°—π§«“¡ª≈Õ¥¿—¬ (‡™àπ

isolator ·≈– lamina flow work bench) √«¡∑—ÈßªØ‘∫—µ‘ß“π„π∫√‘‡«≥∑’Ë·¬°‡ªìπ —¥ à«π®“°∫√‘‡«≥Õ◊ËπÊ

7.5 §«√®—¥„Àâ¡’µŸâ‡°Á∫‡Õ° “√ ”§—≠‡æ◊ËÕ„Àâ¡—Ëπ„®«à“‡Õ° “√∑ÿ°™π‘¥‰¥â√—∫°“√‡°Á∫√—°…“Õ¬à“ßª≈Õ¥¿—¬

‚¥¬µŸâ‡°Á∫‡Õ° “√¥—ß°≈à“«§«√‰¥â√—∫°“√ÕÕ°·∫∫„Àâ¡’ ¿“«–∑’Ë‡À¡“– ¡°—∫°“√®—¥‡°Á∫‡Õ° “√·≈– “¡“√∂

ªÑÕß°—π°“√‡ ◊ËÕ¡ ¿“æ¢Õß‡Õ° “√ °“√‡¢â“∂÷ß‡Õ° “√‡À≈à“π’È§«√‰¥â√—∫°“√§«∫§ÿ¡Õ¬à“ß‡¢â¡ß«¥‚¥¬∫ÿ§≈“°√

∑’Ë‰¥â√—∫¡Õ∫À¡“¬

7.6 §«√®—¥∑”¢—ÈπµÕπ°“√ªØ‘∫—µ‘„π°“√°”®—¥¢Õß‡ ’¬Õ¬à“ßª≈Õ¥¿—¬ ´÷Ëß√«¡∂÷ß¢Õß‡ ’¬∑’Ë‡ªìπæ‘…

(∑—Èß∑“ß‡§¡’·≈–∑“ß™’«¿“æ) “√∑”ªØ‘°‘√‘¬“ µ—«Õ¬à“ß µ—«∑”≈–≈“¬ ·≈–·ºàπ°√ÕßÕ“°“»

7.7 À“°¡’°“√∑¥ Õ∫∑“ß®ÿ≈™’««‘∑¬“ §«√∑”„πÀâÕßªØ‘∫—µ‘°“√∑’Ë‰¥â√—∫°“√ÕÕ°·∫∫·≈–°àÕ √â“ß¡“

‚¥¬‡©æ“– ‚¥¬ “¡“√∂»÷°…“·π«∑“ßªØ‘∫—µ‘‡æ‘Ë¡‡µ‘¡‰¥â®“°√à“ßÀ≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫ÀâÕßªØ‘∫—µ‘°“√®ÿ≈™’««‘∑¬“

¢Õß‡¿ —™¿—≥±å ¢ÕßÕß§å°“√Õπ“¡—¬‚≈° (WHO guideline on good practices for pharmaceutical microbiology

laboratories (reference QAS/09.297))

7.8 À“°¢Õ∫‡¢µ°“√ªØ‘∫—µ‘ß“π¢ÕßÀâÕßªØ‘∫—µ‘°“√§√Õ∫§≈ÿ¡∂÷ß°“√∑¥ Õ∫∑“ß™’««‘∑¬“„π —µ«å∑¥≈Õß

(‡™àπ °“√∑¥ Õ∫À“ “√°àÕ‰¢â À√◊Õ pyrogen test „π°√–µà“¬) ∂“π∑’Ë‡æ“–‡≈’È¬ß —µ«å∑¥≈Õß §«√·¬°‡ªìπ

—¥ à«π®“°ÀâÕßªØ‘∫—µ‘°“√Õ◊ËπÊ ‚¥¬¡’∑“ß‡¢â“ÕÕ°·≈–√–∫∫ª√—∫Õ“°“»·¬°µà“ßÀ“° ·≈–§«√ªØ‘∫—µ‘µ“¡·π«∑“ß

·≈–¢âÕ°”Àπ¥‡©æ“–¥â“π∑’Ë‡°’Ë¬«¢âÕß (18)



38

Laboratory storage facilities

7.9 The storage facilities should be well organized for the correct storage of samples,reagents and equipment.

7.10 Separate storage facilities should be maintained for the secure storage of samples,retained samples (see Part three, section 20), reagents and laboratory accessories (see Part two,sections 10.13 - 10.14), reference substances and reference materials (see Part two, section 11).Storage facilities should be equipped to store material, if necessary, under refrigeration (2 - 8 ÌC)and frozen (-20 ÌC) and securely locked. All specified storage conditions should be controlled,monitored and records maintained. Access should be restricted to designated personnel.

7.11 Appropriate safety procedures should be drawn up and rigorously implementedwherever toxic or flammable reagents are stored or used. The laboratory should provideseparate rooms or areas for storing flammable substances, fuming and concentrated acids andbases, volatile amines and other reagents, such as hydrochloric acid, nitric acid, ammoniaand bromine. Self-igniting materials, such as metallic sodium and potassium, should also bestored separately. Small stocks of acids, bases and solvents may be kept in the laboratory storebut the main stocks of these items should preferably be retained in a store separate fromthe laboratory building.

7.12 Reagents subject to poison regulations or to the controls applied to narcoticand psychotropic substances should be clearly marked as required by national legislation. Theyshould be kept separately from other reagents in locked cabinets. A designated responsiblemember of staff should maintain a register of these substances. The head of each unit shouldaccept personal responsibility for the safekeeping of any of these reagents kept in the workplace.

7.13 Gases also should be stored in a dedicated store, if possible isolated from the mainbuilding. Wherever possible gas bottles in the laboratory are to be avoided and distribution froman external gas store is preferred. If gas bottles are present in the laboratory they should besafely secured.

Note: Consideration should be given to the installation of gas generators.


39À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

ÀâÕßÀ√◊ÕµŸâ‡°Á∫¢Õß ”À√—∫ÀâÕßªØ‘∫—µ‘°“√

7.9 §«√¡’°“√®—¥√–‡∫’¬∫ÀâÕßÀ√◊ÕµŸâ‡°Á∫ “√‡§¡’·≈–Õÿª°√≥å ‡æ◊ËÕ„Àâ “¡“√∂‡°Á∫√—°…“µ—«Õ¬à“ß “√∑”

ªØ‘°‘√‘¬“ ·≈–Õÿª°√≥åµà“ßÊ ‰¥âÕ¬à“ß∂Ÿ°µâÕß·≈–‡À¡“– ¡

7.10 §«√·¬°µŸâ‡°Á∫¢ÕßÕÕ°‡ªìπÀ¡«¥À¡Ÿà ‡æ◊ËÕ§«“¡ª≈Õ¥¿—¬„π°“√®—¥‡°Á∫µ—«Õ¬à“ß µ—«Õ¬à“ß∑’Ë‡À≈◊Õ

(retained samples) (¥Ÿ à«π∑’Ë 3 ¢âÕ 20) “√∑”ªØ‘°‘√‘¬“ ·≈–«— ¥ÿÕÿª°√≥åµà“ßÊ „πÀâÕßªØ‘∫—µ‘°“√ (¥Ÿ à«π∑’Ë 2

¢âÕ 10.13 - 10.14) “√¡“µ√∞“π ·≈–«— ¥ÿÕâ“ßÕ‘ß (¥Ÿ à«π∑’Ë 2 ¢âÕ 11) ‚¥¬µŸâ‡°Á∫¢Õß§«√‰¥â√—∫°“√ÕÕ°·∫∫·≈–

µ‘¥µ—ÈßÕÿª°√≥å ”À√—∫ ¿“«–°“√‡°Á∫√—°…“µà“ßÊ ‡™àπ °“√®—¥‡°Á∫«— ¥ÿ¿“¬„µâÕÿ≥À¿Ÿ¡‘µŸâ‡¬Áπ (2 - 8 Õß»“‡´≈‡´’¬ )

·≈–°“√·™à·¢Áß (-20 Õß»“‡´≈‡ ’¬ ) ·≈–¡’°“√ªî¥≈ÁÕ§Õ¬à“ß¥’ §«√¡’°“√§«∫§ÿ¡ ‡ΩÑ“µ‘¥µ“¡·≈–∫—π∑÷°‰«â∑ÿ°

¿“«–°“√‡°Á∫∑’Ë°”Àπ¥ °“√‡∫‘°„™â«— ¥ÿ¥—ß°≈à“«§«√‰¥â√—∫°“√§«∫§ÿ¡Õ¬à“ß‡¢â¡ß«¥‚¥¬∫ÿ§≈“°√∑’Ë‰¥â√—∫¡Õ∫À¡“¬

7.11 §«√¡’°“√®—¥∑”¢—ÈπµÕπ°“√¥”‡π‘π°“√·≈–π”‰ªªØ‘∫—µ‘ ‡æ◊ËÕ°“√§«∫§ÿ¡§«“¡ª≈Õ¥¿—¬Õ¬à“ß

‡¢â¡ß«¥ ”À√—∫°“√‡°Á∫À√◊Õ„™â«—µ∂ÿ¡’æ‘… À√◊Õ “√∑’Ëµ‘¥‰ø‰¥â ‚¥¬ÀâÕßªØ‘∫—µ‘°“√§«√®—¥„Àâ¡’ÀâÕßÀ√◊Õ∫√‘‡«≥∑’Ë·¬°

ÕÕ°‰ª‡æ◊ËÕ„Àâ‡°Á∫ “√∑’Ëµ‘¥‰ø‰¥â “√∑’Ë¡’§«—π °√¥À√◊Õ¥à“ß‡¢â¡¢âπ ·≈– “√√–‡À¬®”æ«°‡Õ¡’π À√◊Õ “√∑”ªØ‘°‘√‘¬“

Õ◊ËπÊ ‡™àπ °√¥‰Œ‚¥√§≈Õ√‘° °√¥‰πµ√‘° ·Õ¡‚¡‡π’¬ ·≈–‚∫√¡’π «—µ∂ÿ∑’Ëµ‘¥‰ø‰¥â‡Õß ‡™àπ ‚≈À–®”æ«°‚´‡¥’¬¡

·≈– ‚æ·∑ ‡´’¬¡ §«√‡°Á∫·¬°®“° “√Õ◊Ëπ Õ“®‡°Á∫°√¥ ¥à“ß ·≈–µ—«∑”≈–≈“¬®”π«ππâÕ¬‰«â„πÀâÕßªØ‘∫—µ‘°“√‰¥â

·µà§≈—ßÀ≈—°∑’Ë‡°Á∫ “√§«√Õ¬Ÿà„π∫√‘‡«≥∑’Ë·¬°ÕÕ°‰ª®“°Õ“§“√∑’Ëµ—ÈßÀâÕßªØ‘∫—µ‘°“√

7.12 “√∑”ªØ‘°‘√‘¬“∑’Ëµ“¡°ÆÀ¡“¬®—¥‡ªìπ “√æ‘… ·≈–«—µ∂ÿ‡ æµ‘¥À√◊Õ«—µ∂ÿÕÕ°ƒ∑∏‘ÏµàÕ®‘µª√– “∑

§«√¡’°“√√–∫ÿ¢âÕ§«“¡∑’Ë°ÆÀ¡“¬°”Àπ¥Õ¬à“ß™—¥‡®π ·≈–§«√·¬°‡°Á∫ “√‡À≈à“π’È‰«â„πµŸâ‡°Á∫ “√∑’Ë “¡“√∂ªî¥≈ÁÕ§‰¥â

‚¥¬§«√¡’ºŸâ√—∫º‘¥™Õ∫®”π«πÀπ÷Ëß´÷Ëß‰¥â√—∫¡Õ∫À¡“¬„Àâ∑”Àπâ“∑’Ë¥Ÿ·≈‡°’Ë¬«°—∫°“√®—¥∑”∑–‡∫’¬π¢Õß “√°≈ÿà¡π’È

À—«Àπâ“Àπà«¬ªØ‘∫—µ‘ß“π·µà≈–Àπà«¬§«√√—∫º‘¥™Õ∫„π°“√‡°Á∫√—°…“ “√‡À≈à“π’È„Àâª≈Õ¥¿—¬„π ∂“π∑’ËªØ‘∫—µ‘ß“π

7.13 “√®”æ«°°ä“´§«√®—¥‡°Á∫„π ∂“π∑’Ë‡©æ“–´÷Ëß·¬°®“°Õ“§“√À≈—° À“°‡ªìπ‰ª‰¥â§«√À≈’°‡≈’Ë¬ß

°“√‡°Á∫¢«¥°ä“´„πÀâÕßªØ‘∫—µ‘°“√ ·≈–‰¥â√—∫°“√‡∫‘°®à“¬®“°·À≈àß‡°Á∫°ä“´∑’ËÕ¬Ÿà¿“¬πÕ°ÀâÕßªØ‘∫—µ‘°“√ (external

gas store) À“°¡’°“√‡°Á∫¢«¥°ä“´‰«â„πÀâÕßªØ‘∫—µ‘°“√ §«√‡°Á∫‰«â„π∑’Ëª≈Õ¥¿—¬

À¡“¬‡Àµÿ: Õ“®æ‘®“√≥“µ‘¥µ—Èß gas generators



40

8. Equipment, instruments and other devices

8.1 Equipment, instruments and other devices should be designed, constructed, adapted,located, calibrated, qualified, verified and maintained as required by the operations to be carried outin the local environment. The user should purchase the equipment from an agent capable ofproviding full technical support and maintenance when necessary.

8.2 The laboratory should have the required test equipment, instruments and other devicesfor the correct performance of the tests and/or calibrations, validations and verifications (includingthe preparation of samples and the processing and analysis of test and/or calibration data).

8.3 Equipment, instruments and other devices, including those used for sampling,should meet the laboratoryûs requirements and comply with the relevant standard specifications,as well as being verified, qualified and/or calibrated regularly (see Part two, section 12).

9. Contracts

Purchasing services and supplies

9.1 The laboratory should have a procedure for the selection and purchasing of servicesand supplies it uses that affect the quality of testing.

9.2 The laboratory should evaluate suppliers of critical consumables, supplies andservices which affect quality of testing, maintain records of these evaluations and listapproved suppliers, which have been demonstrated to be of a suitable quality with respect tothe requirements of the laboratory.

Subcontracting of testing

9.3 When a laboratory subcontracts work, which may include specific testing, it is to bedone with organizations approved for the type of activity required. The laboratory is responsiblefor periodically assessing the competence of a contracted organization.

9.4 When a laboratory performs testing for a customer and subcontracts part of thetesting, it should advise the customer of the arrangement in writing and, if appropriate, gain his orher approval.

9.5 There should be a written contract which clearly establishes the duties andresponsibilities of each party, defines the contracted work and any technical arrangements madein connection with it. The contract should permit the laboratory to audit the facilities andcompetencies of the contracted organization and ensure the access of the laboratory to recordsand retained samples.


41À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

8. ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ

8.1 ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ §«√‰¥â√—∫°“√ÕÕ°·∫∫ º≈‘µ/ √â“ß ª√—∫ª√ÿß µ‘¥µ—Èß

Õ∫‡∑’¬∫ µ√«® Õ∫§ÿ≥¿“æ ∑«π Õ∫ ·≈–∫”√ÿß√—°…“„Àâ‡À¡“– ¡°—∫ ¿“«–°“√„™âß“π·≈– ¿“«–·«¥≈âÕ¡

§«√®—¥´◊ÈÕ‡§√◊ËÕß¡◊Õ®“°µ—«·∑π®”Àπà“¬∑’Ë “¡“√∂„Àâ°“√∫√‘°“√¥â“π‡∑§π‘§·≈–°“√ àÕ¡∫”√ÿß‰¥âÕ¬à“ß§√∫∂â«π

8.2 ÀâÕßªØ‘∫—µ‘°“√§«√¡’‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ”À√—∫°“√∑¥ Õ∫ ·≈–/À√◊Õ

°“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß ·≈–°“√∑«π Õ∫ (√«¡∂÷ß°“√‡µ√’¬¡µ—«Õ¬à“ßµà“ßÊ ·≈–

°“√ª√–¡«≈º≈ ·≈–°“√«‘‡§√“–Àå¢âÕ¡Ÿ≈°“√∑¥ Õ∫ ·≈–/À√◊Õ¢âÕ¡Ÿ≈°“√ Õ∫‡∑’¬∫)

8.3 ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ √«¡∂÷ß‡§√◊ËÕß¡◊Õ∑’Ë„™â„π°“√ ÿà¡µ—«Õ¬à“ß§«√‰¥â¡“µ√∞“π

µ“¡¢âÕ°”Àπ¥¢ÕßÀâÕßªØ‘∫—µ‘°“√·≈– Õ¥§≈âÕß°—∫¡“µ√∞“π∑’Ë‡°’Ë¬«¢âÕß ·≈–§«√‰¥â√—∫°“√∑«π Õ∫

°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘ ·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫Õ¬à“ß ¡Ë”‡ ¡Õ (¥Ÿ à«π∑’Ë 2 ¢âÕ 12)

9. °“√∑”¢âÕµ°≈ßµà“ßÊ

°“√®—¥´◊ÈÕ ‘π§â“·≈–∫√‘°“√

9.1 ÀâÕßªØ‘∫—µ‘°“√§«√¡’¢—ÈπµÕπ°“√¥”‡π‘πß“π„π°“√§—¥‡≈◊Õ°·≈–°“√®—¥´◊ÈÕ ‘π§â“·≈–∫√‘°“√ ∑’Ë¡’º≈

µàÕ§ÿ≥¿“æ°“√∑¥ Õ∫

9.2 ÀâÕßªØ‘∫—µ‘°“√§«√¡’°“√ª√–‡¡‘πºŸâ àß¡Õ∫ (§Ÿà§â“) «— ¥ÿ ‘Èπ‡ª≈◊Õß ‘π§â“·≈–∫√‘°“√∑’Ë¡’§«“¡ ”§—≠

´÷Ëß¡’º≈µàÕ§ÿ≥¿“æ°“√∑¥ Õ∫ ‚¥¬¡’°“√®—¥∑”∫—π∑÷°º≈°“√ª√–‡¡‘π ·≈–®—¥∑”√“¬™◊ËÕºŸâ àß¡Õ∫∑’Ëºà“π°“√

ª√–‡¡‘π·≈–‰¥â√—∫°“√√—∫√Õß ´’Ëß “¡“√∂„™â‡ªìπ¢âÕ¡Ÿ≈Õâ“ßÕ‘ß‰¥â«à“ ‘π§â“·≈–∫√‘°“√¢ÕßºŸâ àß¡Õ∫√“¬π—Èπ¡’§ÿ≥¿“æ

‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥¢ÕßÀâÕßªØ‘∫—µ‘°“√

°“√®â“ß‡À¡“™à«ßß“π∑¥ Õ∫

9.3 „π°√≥’∑’ËÀâÕßªØ‘∫—µ‘°“√¡’°“√®â“ß‡À¡“™à«ßß“π ÷ËßÕ“®√«¡∂÷ß°“√®â“ßß“π∑¥ Õ∫∑’Ë®”‡æ“–

§«√®â“ßÕß§å°√∑’Ë‰¥â√—∫°“√√—∫√Õß ”À√—∫°“√µ√«®«‘‡§√“–Àå™π‘¥π—Èπ ‚¥¬ÀâÕßªØ‘∫—µ‘°“√√—∫º‘¥™Õ∫ª√–‡¡‘π

§«“¡ “¡“√∂·≈–»—°¬¿“æ¢ÕßºŸâ√—∫‡À¡“™à«ß

9.4 ÀâÕßªØ‘∫—µ‘°“√§«√·®âß„Àâ≈Ÿ°§â“∑√“∫‡ªìπ≈“¬≈—°…≥åÕ—°…√ ·≈–„Àâ≈Ÿ°§â“‡ªìπºŸâÕπÿ¡—µ‘ (µ“¡§«“¡

‡À¡“– ¡) „π°√≥’∑’Ë®â“ßÀπà«¬ß“πÀ√◊Õ∫√‘…—∑Õ◊Ëπ„Àâµ√«®«‘‡§√“–Àå·∑π„π∫“ßÀ—«¢âÕ°“√∑¥ Õ∫

9.5 §«√®—¥∑”‡Õ° “√ —≠≠“ ÷Ëß√–∫ÿÀπâ“∑’Ë·≈–§«“¡√—∫º‘¥™Õ∫¢Õß§Ÿà —≠≠“∑ÿ°ΩÉ“¬‰«âÕ¬à“ß™—¥‡®π

√«¡∑—ÈßµâÕß√–∫ÿ≈—°…≥–¢Õßß“π∑’Ë«à“®â“ß·≈–‡∑§π‘§«‘∏’°“√µà“ßÊ ∑’Ë‡°’Ë¬«¢âÕß ‚¥¬„π —≠≠“§«√√–∫ÿ„ÀâÀâÕßªØ‘∫—µ‘

°“√ “¡“√∂∑”°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘·≈–§«“¡ “¡“√∂¢ÕßºŸâ√—∫‡À¡“™à«ß √«¡∂÷ß°“√‡√’¬°¥Ÿ∫—π∑÷°¢âÕ¡Ÿ≈

·≈–µ—«Õ¬à“ß∑’Ë‡°Á∫‰«â‰¥â



42

9.6 The contracted organization should not pass to a third party any work entrustedto it under contract without the laboratoryûs prior evaluation and approval of the arrangements.

9.7 The laboratory should maintain a register of all subcontractors that it uses and arecord of the assessment of the competence of subcontractors.

9.8 The laboratory takes the responsibility for all results reported, including thosefurnished by the subcontracting organization.

Part two. Materials, equipment, instruments and other devices

10. Reagents

10.1 All reagents and chemicals, including solvents and materials used in tests and assays,should be of appropriate quality.

10.2 Reagents should be purchased from reputable, approved suppliers and should beaccompanied by the certificate of analysis, and the material safety data sheet, if required.

10.3 In the preparation of reagent solutions in the laboratory:

(a) responsibility for this task should be clearly specified in the job description ofthe person assigned to carry it out; and

(b) prescribed procedures should be used which are in accordance with publishedpharmacopoeial or other standards where available. Records should be kept of thepreparation and standardization of volumetric solutions.

10.4 The labels of all reagents should clearly specify:

(a) content;

(b) manufacturer;

(c) date received and date of opening of the container;

(d) concentration, if applicable;

(e) storage conditions; and

(f) expiry date or retest date, as justified.


43À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

9.6 ∫√‘…—∑§Ÿà —≠≠“√—∫‡À¡“™à«ß ‰¡à§«√ àßµàÕß“π„Àâ·°à∫ÿ§§≈¿“¬πÕ°À√◊Õ∑”°“√®â“ß‡À¡“™à«ßß“π„¥Ê

∑’ËÕ¬Ÿà¿“¬„µâ —≠≠“ ‚¥¬¡‘‰¥â√—∫Õπÿ≠“µ®“°ÀâÕßªØ‘∫—µ‘°“√

9.7 ÀâÕßªØ‘∫—µ‘°“√§«√®—¥∑”∑–‡∫’¬πºŸâ√—∫‡À¡“™à«ß∑ÿ°√“¬ ‡æ◊ËÕπ”¡“„™â·≈–∫—π∑÷°º≈°“√ª√–‡¡‘π

§«“¡ “¡“√∂¢ÕßºŸâ√—∫‡À¡“™à«ß

9.8 ÀâÕßªØ‘∫—µ‘°“√‡ªìπºŸâ√—∫º‘¥™Õ∫√“¬ß“πº≈°“√«‘‡§√“–Àå∑—ÈßÀ¡¥ √«¡∑—Èßº≈°“√«‘‡§√“–Àå®“°

ºŸâ√—∫‡À¡“™à«ß¥â«¬

à«π∑’Ë 2 «— ¥ÿ ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ

10. “√∑”ªØ‘°‘√‘¬“

10.1 “√∑”ªØ‘°‘√‘¬“ ·≈– “√‡§¡’∑ÿ°™π‘¥ √«¡∑—Èßµ—«∑”≈–≈“¬·≈–«— ¥ÿ∑’Ë„™â„π°“√∑¥ Õ∫·≈–°“√«‘‡§√“–Àå

§«√¡’§ÿ≥¿“æ‡À¡“– ¡

10.2 §«√®—¥´◊ÈÕ “√∑”ªØ‘°‘√‘¬“®“°ºŸâ àß¡Õ∫∑’Ë¡’™◊ËÕ‡ ’¬ß ‡ªìπ∑’Ë¬Õ¡√—∫ ·≈–¡’„∫√—∫√Õßº≈°“√«‘‡§√“–Àå

·≈–‡Õ° “√¢âÕ¡Ÿ≈§«“¡ª≈Õ¥¿—¬ ·π∫¡“æ√âÕ¡¥â«¬

10.3 °“√‡µ√’¬¡ “√≈–≈“¬∑”ªØ‘°‘√‘¬“„πÀâÕßªØ‘∫—µ‘°“√

(a) §«√¡’°“√√–∫ÿÀπâ“∑’Ë§«“¡√—∫º‘¥™Õ∫‰«â„π§”∫√√¬“¬≈—°…≥–ß“π¢ÕßºŸâ∑’Ë‰¥â√—∫¡Õ∫À¡“¬Õ¬à“ß

™—¥‡®π ·≈–

(b) §«√‡µ√’¬¡ “√≈–≈“¬µ“¡¢—ÈπµÕπ°“√‡µ√’¬¡∑’Ë‡¢’¬π‰«â´÷Ëß‡ªìπ«‘∏’∑’Ë Õ¥§≈âÕß°—∫µ”√“¬“ À√◊Õ

¡“µ√∞“πÕ◊ËπÊ ∑’Ë„™â‚¥¬∑—Ë«‰ª·≈–§«√¡’°“√‡°Á∫∫—π∑÷°¢âÕ¡Ÿ≈°“√‡µ√’¬¡ ·≈–°“√À“§à“¡“µ√∞“π

¢Õß “√≈–≈“¬‡™‘ßª√‘¡“µ√‰«â¥â«¬

10.4 ©≈“°¢Õß “√∑”ªØ‘°‘√‘¬“∑ÿ°™π‘¥ §«√√–∫ÿ√“¬≈–‡Õ’¬¥µàÕ‰ªπ’ÈÕ¬à“ß™—¥‡®π

(a) à«πª√–°Õ∫

(b) ºŸâº≈‘µ

(c) «—π‡¥◊Õπªï∑’Ë‰¥â√—∫ “√ ·≈–«—π‡¥◊Õπªï∑’Ë‡ªî¥„™â

(d) §«“¡‡¢â¡¢âπ¢Õß “√ (∂â“¡’)

(e) ¿“«–°“√‡°Á∫√—°…“ ·≈–

(f) «—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à (µ“¡§«“¡‡À¡“– ¡)



44

10.5 The labels of reagent solutions prepared in the laboratory should clearly specify:

(a) name;

(b) date of preparation and initials of technician or analyst;

(c) expiry date or retest date, as justified; and

(d) concentration, if applicable.

10.6 The labels for volumetric solutions prepared in the laboratory should clearly specify:

(a) name;

(b) molarity (or concentration);

(c) date of preparation and initials of technician/analyst;

(d) date of standardization and initials of technician/analyst; and

(e) standardization factor.

Note: The laboratory should ensure that the volumetric solution is suitable for use at thetime of use.

10.7 In the transportation and subdivision of reagents:

(a) whenever possible they should be transported in the original containers; and

(b) when subdivision is necessary, clean containers should be used and appropriatelylabelled.

Visual inspection

10.8 All reagent containers should be visually inspected to ensure that the seals are intact,both when they are delivered to the store and when they are distributed to the units.

10.9 Reagents that appear to have been tampered with should be rejected; however,this requirement may exceptionally be waived if the identity and purity of the reagent concernedcan be confirmed by testing.

Water

10.10 Water should be considered as a reagent. The appropriate grade for a specifictest should be used as described in the pharmacopoeias or in an approved test when available.

10.11 Precautions should be taken to avoid contamination during its supply, storageand distribution.

10.12 The quality of the water should be verified regularly to ensure that the variousgrades of water meet the appropriate specifications.


45À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

10.5 ©≈“°¢Õß “√≈–≈“¬∑’Ë‡µ√’¬¡„πÀâÕßªØ‘∫—µ‘°“√§«√√–∫ÿ√“¬≈–‡Õ’¬¥µàÕ‰ªπ’ÈÕ¬à“ß™—¥‡®π

(a) ™◊ËÕ “√≈–≈“¬

(b) «—π∑’Ë‡µ√’¬¡ “√≈–≈“¬ ·≈–™◊ËÕ¬àÕ¢Õßπ—°‡∑§π‘§/π—°«‘‡§√“–Àå∑’Ë‡µ√’¬¡

(c) «—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à (µ“¡§«“¡‡À¡“– ¡) ·≈–

(d) §«“¡‡¢â¡¢âπ (∂â“¡’)

10.6 ©≈“°¢Õß “√≈–≈“¬‡™‘ßª√‘¡“µ√∑’Ë‡µ√’¬¡„πÀâÕßªØ‘∫—µ‘°“√§«√√–∫ÿ√“¬≈–‡Õ’¬¥µàÕ‰ªπ’ÈÕ¬à“ß™—¥‡®π

(a) ™◊ËÕ¢Õß “√≈–≈“¬‡™‘ßª√‘¡“µ√

(b) molarity (À√◊Õ §«“¡‡¢â¡¢âπ)

(c) «—π‡¥◊Õπªï∑’Ë‡µ√’¬¡ ·≈–™◊ËÕ¬àÕ¢Õß™◊ËÕπ—°‡∑§π‘§/π—°«‘‡§√“–Àå∑’Ë‡µ√’¬¡

(d) «—π‡¥◊Õπªï∑’Ë∑¥ Õ∫À“§à“¡“µ√∞“π ·≈–™◊ËÕ¬àÕ¢Õßπ—°‡∑§π‘§/π—°«‘‡§√“–Àå∑’ËÀ“§à“¡“µ√∞“π ·≈–

(e) Õß§åª√–°Õ∫„π°“√§”π«≥§à“¡“µ√∞“π

À¡“¬‡Àµÿ: ÀâÕßªØ‘∫—µ‘°“√§«√¡—Ëπ„®«à“ “√≈–≈“¬‡™‘ßª√‘¡“µ√¬—ß‡À¡“– ¡„π°“√π”¡“„™â

10.7 °“√¢π àß À√◊Õ°“√·∫àß∫√√®ÿ “√∑”ªØ‘°‘√‘¬“

(a) À“°‡ªìπ‰ª‰¥â §«√¢π àß “√„π¿“™π–∫√√®ÿ‡¥‘¡ ·≈–

(b) À“°®”‡ªìπµâÕß·∫àß∫√√®ÿ §«√„™â¿“™π–∫√√®ÿ∑’Ë –Õ“¥ ·≈–µ‘¥©≈“° Õ¬à“ß‡À¡“– ¡

°“√µ√«® Õ∫‚¥¬°“√¡Õß¥â«¬µ“

10.8 ¿“™π–∫√√®ÿ “√∑”ªØ‘°‘√‘¬“∑ÿ°™π‘¥§«√‰¥â√—∫°“√µ√«® Õ∫‚¥¬°“√¡Õß¥â«¬µ“ ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“

«— ¥ÿ∑’Ë„™âªî¥ºπ÷° (seal) π—Èπ¬—ß§ßÕ¬Ÿà„π ¿“æ∑’Ë ¡∫Ÿ√≥å ‰¡à¡’√àÕß√Õ¬°“√‡ªî¥„™â ∑—Èß„π¢≥–∑’Ë√—∫‡¢â“ÀâÕß‡°Á∫ “√

·≈–‡¡◊ËÕ∑”°“√·®°®à“¬‰ª¬—ßÀπà«¬ªØ‘∫—µ‘°“√µà“ßÊ

10.9 §«√°”®—¥ “√∑”ªØ‘°‘√‘¬“∑’Ëæ∫«à“∂Ÿ°ªπ‡ªóôÕπ ‡«âπ·µà “¡“√∂∑”°“√∑¥ Õ∫‡æ◊ËÕ¬◊π¬—π™π‘¥·≈–

§«“¡∫√‘ ÿ∑∏‘Ï¢Õß “√‰¥â

πÈ”

10.10 §«√„Àâ§«“¡ ”§—≠°—∫πÈ”‡ ¡◊Õπ‡ªìπ “√∑”ªØ‘°‘√‘¬“™π‘¥Àπ÷Ëß ·≈–§«√„™âπÈ”™π‘¥µà“ßÊ „Àâ‡À¡“– ¡

µ“¡∑’Ë√–∫ÿ„πµ”√“¬“À√◊Õ„π«‘∏’∑¥ Õ∫∑’Ë‰¥â√—∫°“√√—∫√Õß

10.11 §«√ªØ‘∫—µ‘µ“¡¢âÕ§«√√–«—ßµà“ßÊ ‡æ◊ËÕÀ≈’°‡≈’Ë¬ß°“√ªπ‡ªóôÕπ„π√–À«à“ß°“√®—¥ àß °“√‡°Á∫√—°…“

·≈–°“√·®°®à“¬

10.12 §«√∑”°“√µ√«® Õ∫§ÿ≥¿“æπÈ”Õ¬à“ß ¡Ë”‡ ¡Õ ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“πÈ”™π‘¥µà“ßÊ ¡’§ÿ≥ ¡∫—µ‘‡ªìπ‰ª

µ“¡¢âÕ°”Àπ¥



46

Storage

10.13 Stocks of reagents should be maintained in a store under the appropriate storageconditions (ambient temperature, under refrigeration or frozen). The store should contain a supplyof clean bottles, vials, spoons, funnels and labels, as required, for dispensing reagents from largerto smaller containers. Special equipment may be needed for the transfer of larger volumes ofcorrosive liquids.

10.14 The person in charge of the store is responsible for looking after the storagefacilities and their inventory and for noting the expiry date of chemicals and reagents. Trainingmay be needed in handling chemicals safely and with the necessary care.

11. Reference substances and reference materials

11.1 Reference substances (primary reference substances or secondary referencesubstances (8)) are used for the testing of a sample.

Note: Pharmacopoeial reference substances should be employed when available andappropriate for the analysis. When a pharmacopoeia reference substance has not beenestablished then the manufacturer should use its own reference substance.

11.2 Reference materials may be necessary for the calibration and/or qualification ofequipment, instruments or other devices.

Registration and labelling

11.3 An identification number should be assigned to all reference substances, exceptfor pharmacopoeial reference substances.

11.4 A new identification number should be assigned to each new batch.

11.5 This number should be marked on each vial of the reference substance.

11.6 The identification number should be quoted on the analytical worksheet every timethe reference substance is used (see Part three, section 15.5). In the case of pharmacopoeialreference substances the batch number and/or the batch validity statement should be attachedto the worksheet.

11.7 The register for all reference substances and reference materials should bemaintained and contain the following information:

(a) the identification number of the substance or material;

(b) a precise description of the substance or material;

(c) the source;


47À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

°“√‡°Á∫√—°…“

10.13 §«√‡°Á∫ “√∑”ªØ‘°‘√‘¬“„πÀâÕß∑’Ë¡’ ¿“«–°“√‡°Á∫∑’Ë‡À¡“– ¡ (Õÿ≥À¿Ÿ¡‘ÀâÕß „πµŸâ‡¬Áπ À√◊Õ·™à·¢Áß)

‚¥¬ÀâÕß‡°Á∫§«√¡’¢«¥ –Õ“¥ ¢«¥·°â«¢π“¥‡≈Á° ™âÕπ °√«¬ ·≈–©≈“° (µ“¡§«“¡®”‡ªìπ) ”À√—∫„™â·∫àß

“√®“°¿“™π–¢π“¥„À≠à„ à„π¿“™π–¢π“¥‡≈Á° Õ“®¡’Õÿª°√≥åæ‘‡»…Õ◊ËπÊ ”À√—∫°“√·∫àß¢Õß‡À≈«∑’Ë¡’ƒ∑∏‘Ï

°—¥°√àÕπ

10.14 ºŸâ√—∫º‘¥™Õ∫ÀâÕß‡°Á∫ “√ ¡’Àπâ“∑’Ë¥Ÿ·≈Õÿª°√≥å ‘ËßÕ”π«¬§«“¡ –¥«°∑’Ë„™â„π°“√‡°Á∫√—°…“

¿“¬„πÀâÕß‡°Á∫ “√ √«¡∑—ÈßÕ—µ√“°“√À¡ÿπ‡«’¬π¢Õß«— ¥ÿ Õÿª°√≥åµà“ßÊ ·≈–¥Ÿ·≈‰¡à„Àâ¡’ “√‡§¡’·≈– “√∑”

ªØ‘°‘√‘¬“∑’ËÀ¡¥Õ“¬ÿ ·≈–Õ“®®”‡ªìπµâÕß‰¥â√—∫°“√Ωñ°Õ∫√¡¥â“π°“√®—¥°“√ “√‡§¡’Õ¬à“ßª≈Õ¥¿—¬ ·≈–¥â«¬§«“¡

√–¡—¥√–«—ß

11. “√¡“µ√∞“π·≈–«— ¥ÿÕâ“ßÕ‘ß

11.1 „™â “√¡“µ√∞“π ( “√¡“µ√∞“πª∞¡¿Ÿ¡‘À√◊Õ∑ÿµ‘¬¿Ÿ¡‘ (8)) ”À√—∫°“√∑¥ Õ∫µ—«Õ¬à“ß

À¡“¬‡Àµÿ: °√≥’∑’Ë “¡“√∂®—¥À“ “√¡“µ√∞“π‰¥â·≈– “√π—Èπ‡À¡“– ¡ ”À√—∫°“√«‘‡§√“–Àå §«√„™â

“√¡“µ√∞“π∑’Ë√–∫ÿ‰«â„πµ”√“¬“ ·µà°√≥’∑’Ë‰¡à¡’ “√¡“µ√∞“π∑’Ë√–∫ÿ‰«â„πµ”√“¬“ ºŸâº≈‘µ§«√„™â “√¡“µ√∞“π¢Õß

µπ‡Õß

11.2 Õ“®®”‡ªìπµâÕß„™â«— ¥ÿÕâ“ßÕ‘ß ”À√—∫°“√ Õ∫‡∑’¬∫ ·≈–/À√◊Õ °“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ

‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ

°“√®—¥∑”∑–‡∫’¬π¢âÕ¡Ÿ≈·≈–°“√µ‘¥©≈“°

11.3 §«√°”Àπ¥‡≈¢√À— (identification number) ¢Õß “√¡“µ√∞“π∑ÿ°™π‘¥ ¬°‡«âπ “√¡“µ√∞“π¢Õß

µ”√“¬“

11.4 §«√°”Àπ¥‡≈¢√À— „À¡à„Àâ°—∫ “√·µà≈–√ÿàπº≈‘µ„À¡à

11.5 §«√√–∫ÿ‡≈¢√À— ¢Õß “√¡“µ√∞“π∫π¢«¥

11.6 §«√· ¥ß‡≈¢√À— ¢Õß “√¡“µ√∞“π„π·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå∑ÿ°§√—Èß∑’Ë„™â (¥Ÿ à«π∑’Ë 3

¢âÕ 15.5) °√≥’∑’Ë„™â “√¡“µ√∞“π¢Õßµ”√“¬“§«√„ à‡≈¢√ÿàπ∑’Ëº≈‘µ ·≈–/À√◊Õ·π∫‡Õ° “√∑’Ë· ¥ß«à“ “√¡“µ√∞“π

√ÿàπº≈‘µπ—Èπ¬—ß “¡“√∂„™â‰¥â‰ªæ√âÕ¡°—∫·ºàπß“π∫—π∑÷°π—Èπ¥â«¬

11.7 §«√®—¥∑”∑–‡∫’¬π¢âÕ¡Ÿ≈ “√¡“µ√∞“π ·≈–«— ¥ÿÕâ“ßÕ‘ß∑ÿ°™π‘¥ ‚¥¬√–∫ÿ¢âÕ¡Ÿ≈¥—ßµàÕ‰ªπ’È:

(a) ‡≈¢√À— ¢Õß “√¡“µ√∞“π À√◊Õ«— ¥ÿÕâ“ßÕ‘ß

(b) ≈—°…≥–∑’Ë∂Ÿ°µâÕß¢Õß “√¡“µ√∞“π À√◊Õ«— ¥ÿÕâ“ßÕ‘ß

(c) ·À≈àß∑’Ë¡“



48

(d) the date of receipt;

(e) the batch designation or other identification code;

(f) the intended use of the substance or material (e.g. as an infrared referencesubstance or as an impurity reference substance for thin-layer chromatography);

(g) the location of storage in the laboratory, and any special storage conditions;

(h) any further necessary information (e.g. the results of visual inspections);

(i) expiry date or retest date;

(j) certificate (batch validity statement) of a pharmacopoeial reference substanceand a certified reference material which indicates its use, the assigned content,if applicable, and its status (validity); and

(k) in the case of secondary reference substances prepared and supplied by themanufacturer, the certificate of analysis.

11.8 A person should be nominated to be responsible for reference substances andreference materials.

11.9 If a national pharmaceutical quality control laboratory is required to establishreference substances for use by other institutions, a separate reference substances unit shouldbe established.

11.10 In addition a file should be kept in which all information on the properties ofeach reference substance is entered including the safety data sheets.

11.11 For reference substances prepared in the laboratory, the file should include theresults of all tests and verifications used to establish the reference substances and expiry date orretest date; these should be signed by the responsible analyst.

Retesting (monitoring)

11.12 All reference substances prepared in the laboratory or supplied externally shouldbe retested at regular intervals to ensure that deterioration has not occurred. The interval forretesting depends on a number of factors, including stability of the substance, storageconditions employed, type of container and extent of use (how often the container is openedand closed). More detailed information on the handling, storage and retesting of referencesubstances is given in the WHO General guidelines for the establishment, maintenance anddistribution of chemical reference substances (8).

11.13 The results of these tests should be recorded and signed by the responsible analyst.


49À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(d) «—π‡¥◊Õπªï∑’Ë√—∫

(e) ‡≈¢√ÿàπ∑’Ëº≈‘µ À√◊Õ‡≈¢√À— Õ◊Ëπ∑’Ë„™â√–∫ÿ‰¥â

(f) «—µ∂ÿª√– ß§å°“√„™â “√¡“µ√∞“π À√◊Õ«— ¥ÿÕâ“ßÕ‘ß (‡™àπ “√¡“µ√∞“π ”À√—∫ß“πÕ‘πø√“‡√¥

“√¡“µ√∞“π∑’Ë‡ªìπ “√ªπ‡ªóôÕπ ”À√—∫ thin-layer chromatography)

(g) ∫√‘‡«≥∑’Ë‡°Á∫ “√„πÀâÕßªØ‘∫—µ‘°“√ ·≈– ¿“«–æ‘‡»…„π°“√‡°Á∫√—°…“

(h) ¢âÕ¡Ÿ≈Õ◊ËπÊ ∑’Ë®”‡ªìπ (‡™àπ º≈°“√µ√«® Õ∫‚¥¬°“√¡Õß¥â«¬µ“)

(i) «—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à

(j) „∫√—∫√Õß¢Õß “√¡“µ√∞“π¢Õßµ”√“¬“ (‡Õ° “√∑’Ë· ¥ß«à“ “√¡“µ√∞“π√ÿàπ∑’Ëº≈‘µπ—Èπ

¬—ß “¡“√∂„™â‰¥â) ·≈–¢Õß«— ¥ÿÕâ“ßÕ‘ß√—∫√Õß∑’Ë· ¥ß«à“¡’°“√„™âß“π ª√‘¡“≥∑’Ë√–∫ÿ (µ“¡§«“¡

‡À¡“– ¡) ·≈– ∂“π– (°“√· ¥ß«à“ “√π—Èπ¬—ß “¡“√∂„™â‰¥â) ·≈–

(k) „π°√≥’¢Õß “√¡“µ√∞“π∑ÿµ‘¬¿Ÿ¡‘∑’Ë‡µ√’¬¡¢÷Èπ·≈–®—¥À“‚¥¬ºŸâº≈‘µ§«√¡’„∫√—∫√Õßº≈°“√«‘‡§√“–Àå

11.8 §«√·µàßµ—Èß∫ÿ§≈“°√‡æ◊ËÕ√—∫º‘¥™Õ∫ “√¡“µ√∞“π·≈–«— ¥ÿÕâ“ßÕ‘ß

11.9 ”À√—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å√–¥—∫™“µ‘∑’Ëº≈‘µ “√¡“µ√∞“π‡æ◊ËÕ„Àâ ∂“∫—πÕ◊ËπÊ

„™â §«√®—¥µ—Èß°≈ÿà¡ß“π “√¡“µ√∞“π·¬°ÕÕ°¡“

11.10 §«√®—¥‡°Á∫¢âÕ¡Ÿ≈∑—ÈßÀ¡¥‡°’Ë¬«°—∫§ÿ≥ ¡∫—µ‘¢Õß “√¡“µ√∞“π·≈–‡Õ° “√¢âÕ¡Ÿ≈§«“¡ª≈Õ¥¿—¬

¢Õß “√¡“µ√∞“π·µà≈–™π‘¥

11.11 ”À√—∫ “√¡“µ√∞“π∑’Ë‡µ√’¬¡„πÀâÕßªØ‘∫—µ‘°“√π—Èπ §«√®—¥∑”‡Õ° “√¢âÕ¡Ÿ≈∑’Ëª√–°Õ∫¥â«¬

º≈°“√∑¥ Õ∫∑—ÈßÀ¡¥ º≈°“√∑«π Õ∫ ·≈–«—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à ‚¥¬‡Õ° “√‡À≈à“π’È π—°«‘‡§√“–Àå

∑’Ë√—∫º‘¥™Õ∫§«√≈ßπ“¡°”°—∫‰«â¥â«¬

°“√∑¥ Õ∫´È” (°“√‡ΩÑ“µ‘¥µ“¡)

11.12 “√¡“µ√∞“π∑’Ë‡µ√’¬¡„πÀâÕßªØ‘∫—µ‘°“√À√◊Õ®—¥À“¡“®“°¿“¬πÕ°∑—ÈßÀ¡¥ §«√‰¥â√—∫°“√

∑¥ Õ∫„À¡à‡ªìπ√–¬– ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“‰¡à‡°‘¥°“√‡ ◊ËÕ¡ ¿“æ √–¬–‡«≈“¢Õß°“√∑¥ Õ∫„À¡à¢÷ÈπÕ¬Ÿà°—∫ªí®®—¬µà“ßÊ

√«¡∑—Èß§«“¡§ß ¿“æ¢Õß “√¡“µ√∞“π °“√‡°Á∫√—°…“ “√ ™π‘¥¢Õß∫√√®ÿ¿—≥±å °“√‡ªî¥„™â (§«“¡∂’Ë¢Õß°“√

‡ªî¥-ªî¥) ”À√—∫¢âÕ¡Ÿ≈‡æ‘Ë¡‡µ‘¡‡°’Ë¬«°—∫°“√π”¡“„™â °“√‡°Á∫√—°…“·≈–°“√∑¥ Õ∫„À¡à¢Õß “√¡“µ√∞“π ¥Ÿ‰¥â∑’Ë

WHO General guidelines for the establishment, maintenance and distribution of chemical reference

substances (8)

11.13 º≈°“√∑¥ Õ∫‡À≈à“π’È§«√‰¥â√—∫°“√∫—π∑÷° ·≈–≈ßπ“¡°”°—∫‚¥¬π—°«‘‡§√“–Àå∑’Ë√—∫º‘¥™Õ∫



50

11.14 In the case that the result of retesting of a reference substance is noncompliant,a retrospective check of tests performed using this reference substance since its previousexamination should be carried out. For evaluation of outcomes of retrospective checks andconsideration of possible corrective actions, risk analysis should be applied.

11.15 Pharmacopoeial reference substances are regularly retested and the validity(current status) of these reference substances is available from the issuing pharmacopoeia byvarious means, e.g. web sites or catalogues. Retesting by the laboratory is not necessary, providedthe reference substances are stored in accordance with the storage conditions indicated.

12. Calibration, verification of performance and qualification of equipment, instruments

and other devices

12.1 Each item of equipment, instrument or other device used for testing, verificationand/or calibration should, when practicable, be uniquely identified.

12.2 All equipment, instruments and other devices (e.g. volumetric glassware andautomatic dispensers) requiring calibration should be labelled, coded or otherwise identified toindicate the status of calibration and the date when recalibration is due.

12.3 Laboratory equipment should undergo design qualification, installation qualification,operation qualification and performance qualification (for definitions of these terms see theGlossary) (11). Depending on the function and operation of the instrument, the design qualificationof a commercially available standard instrument may be omitted as the installation qualification,operational qualification and performance qualification may be considered to be a sufficientindicator of its suitable design.

12.4 As applicable, the performance of equipment should be verified at appropriateintervals according to a plan established by the laboratory.

12.5 Measuring equipment should be regularly calibrated according to a plan establishedby the laboratory (11).

12.6 Specific procedures should be established for each type of measuring equipment,taking into account the type of equipment, the extent of use and supplierûs recommendations.For example:

- pH meters are verified with standard certified buffer solutions before use;

- balances are to be checked daily using internal calibration and regularly usingsuitable test weights, and requalification should be performed annually usingcertified reference weights.


51À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

11.14 „π°√≥’∑’Ëº≈°“√∑¥ Õ∫„À¡à¢Õß “√¡“µ√∞“π‰¡à Õ¥§≈âÕß°—∫§à“‡¥‘¡ §«√¡’°“√µ√«® Õ∫

¬âÕπÀ≈—ß ”À√—∫º≈«‘‡§√“–Àå∑’Ë„™â “√¡“µ√∞“ππ’È„π°“√«‘‡§√“–Àå ·≈–§«√„™â°“√«‘‡§√“–Àå§«“¡‡ ’Ë¬ß ”À√—∫

ª√–‡¡‘π°“√µ√«® Õ∫º≈«‘‡§√“–Àå¬âÕπÀ≈—ß·≈–æ‘®“√≥“·π«∑“ß·°â‰¢§«“¡º‘¥æ≈“¥

11.15 “√¡“µ√∞“π¢Õßµ”√“¬“‰¥â√—∫°“√∑¥ Õ∫„À¡à‡ªìπ√–¬– ·≈– “¡“√∂À“¢âÕ¡Ÿ≈§«“¡„™â‰¥â¢Õß

“√ (∑’Ë‡ªìπªí®®ÿ∫—π) ®“°À≈“¬·À≈àß ‡™àπ web sites, catalogue ÀâÕßªØ‘∫—µ‘°“√Õ“®‰¡à®”‡ªìπµâÕß∑¥ Õ∫„À¡à

∂â“¡’°“√®—¥‡°Á∫ “√¡“µ√∞“π‡À≈à“π—Èπµ“¡ ¿“«–∑’Ë°”Àπ¥

12. °“√ Õ∫‡∑’¬∫ °“√∑«π Õ∫ ¡√√∂π–·≈–°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–

Õÿª°√≥åÕ◊ËπÊ

12.1 °√≥’ “¡“√∂∑”‰¥â §«√√–∫ÿ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ·µà≈–√“¬°“√∑’Ë„™â ”À√—∫

°“√∑¥ Õ∫ °“√∑«π Õ∫ ·≈–/À√◊Õ °“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊ÕÕ¬à“ß‡©æ“–‡®“–®ß ‰¡à„Àâ´È”°—π

12.2 ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥å (‡™àπ ‡§√◊ËÕß·°â«ª√‘¡“µ√ ¥‘ ‡æπ‡´Õ√å·∫∫Õ—µ‚π¡—µ‘) ∑’Ë

®”‡ªìπµâÕß Õ∫‡∑’¬∫ §«√µ‘¥©≈“° √–∫ÿ‡≈¢∑’ËÀ√◊Õ√À— Õ◊Ëπ„¥∑’Ë· ¥ß ∂“π–¢Õß°“√ Õ∫‡∑’¬∫ ·≈–«—π‡¥◊Õπªï

∑’Ë Õ∫‡∑’¬∫„π§√—ÈßµàÕ‰ª

12.3 ‡§√◊ËÕß¡◊Õ∑’Ë„™â„πÀâÕßªØ‘∫—µ‘°“√ §«√®–ºà“π¢—ÈπµÕπ°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¥â“π°“√ÕÕ°·∫∫

°“√µ‘¥µ—Èß °“√„™âß“π ·≈– ª√– ‘∑∏‘¿“æ°“√∑”ß“π (¥Ÿ§”π‘¬“¡¢Õß»—æ∑å‡À≈à“π’È„πª√–¡«≈§”»—æ∑å) (11) ¢÷ÈπÕ¬Ÿà

°—∫Àπâ“∑’Ë·≈–°“√∑”ß“π¢Õß‡§√◊ËÕß¡◊Õ °“√°”Àπ¥§ÿ≥ ¡∫—µ‘∑’Ë‡ªìπ¡“µ√∞“π¢Õß‡§√◊ËÕß¡◊Õ∑’Ë¡’®”Àπà“¬Õ“®¬°‡≈‘°

∂â“¡’°“√æ‘®“√≥“µ—«™’È«—¥∑’Ë‡À¡“– ¡¥â“π installation, operational ·≈– performance qualification ·≈â«

12.4 §«√∑«π Õ∫ ¡√√∂π–¢Õß‡§√◊ËÕß¡◊Õ«—¥µà“ßÊ ‚¥¬¡’§«“¡∂’Ëµ“¡·ºπ∑’ËÀâÕßªØ‘∫—µ‘°“√‰¥â®—¥∑”‰«â

12.5 §«√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ«—¥Õ¬à“ß ¡Ë”‡ ¡Õµ“¡·ºπ∑’ËÀâÕßªØ‘∫—µ‘‰¥â®—¥∑”‰«â (11)

12.6 §«√®—¥∑”¢—ÈπµÕπ°“√¥”‡π‘πß“π®”‡æ“– ”À√—∫‡§√◊ËÕß¡◊Õ«—¥·µà≈–™π‘¥ ‚¥¬æ‘®“√≥“µ“¡™π‘¥¢Õß

‡§√◊ËÕß¡◊Õ ¢Õ∫‡¢µ°“√„™âß“π ·≈–µ“¡§”·π–π”¢ÕßºŸâ®—¥®”Àπà“¬ µ—«Õ¬à“ß‡™àπ

- ∑«π Õ∫‡§√◊ËÕß«—¥§«“¡‡ªìπ°√¥-‡∫ ¥â«¬ “√≈–≈“¬∫—ø‡øÕ√å¡“µ√∞“π°àÕπ„™â

- µ√«® Õ∫‡§√◊ËÕß™—Ëß∑ÿ°«—π‚¥¬„™â°“√ Õ∫‡∑’¬∫¿“¬„π ·≈–µÿâ¡πÈ”Àπ—°∑’Ë‡À¡“– ¡ ·≈–§«√

µ√«® Õ∫§ÿ≥ ¡∫—µ‘´È”∑ÿ°ªï¥â«¬µÿâ¡πÈ”Àπ—°¡“µ√∞“π



52

12.7 Only authorized personnel should operate equipment, instruments and devices.Up-to-date SOPs on the use, maintenance, verification, qualification and calibration of equipment,instruments and devices (including any relevant manuals provided by the manufacturer) shouldbe readily available for use by the appropriate laboratory personnel together with a scheduleof the dates on which verification and/or calibration is due.

12.8 Records should be kept of each item of equipment, instrument or other device usedto perform testing, verification and/or calibration. The records should include at least the following:

(a) the identity of the equipment, instrument or other device;

(b) the manufacturerûs name and the equipment model, serial number or other uniqueidentification;

(c) the qualification, verification and/or calibration required;

(d) the current location, where appropriate;

(e) the equipment manufacturerûs instructions, if available, or an indication of theirlocation;

(f) the dates, results and copies of reports, verifications and certificates of allcalibrations, adjustments, acceptance criteria and the due date of the nextqualification, verification and/or calibration;

(g) the maintenance carried out to date and the maintenance plan; and

(h) a history of any damage, malfunction, modification or repair. It is alsorecommended that records should be kept and additional observations madeof the time for which the equipment, instruments or devices were used.

12.9 Procedures should include instructions for the safe handling, transport and storageof measuring equipment. On reinstallation, requalification of the equipment is required to ensurethat it functions properly.

12.10 Maintenance procedures should be established, e.g. regular servicing should beperformed by a team of maintenance specialists, whether internal or external, followed byverification of performance.

12.11 Equipment, instruments and other devices, either subjected to overloading ormishandling, giving suspect results, shown to be defective or outside specified limits, should betaken out of service and clearly labelled or marked. Wherever possible they should not be useduntil they have been repaired and requalified.


53À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

12.7 §«√®”°—¥°“√„™â ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ‰«â ”À√—∫∫ÿ§≈“°√∑’Ë‰¥â√—∫¡Õ∫À¡“¬

‡∑à“π—Èπ ·≈–πÕ°®“°π’È„πÀâÕßªØ‘∫—µ‘°“√§«√¡’¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π °“√∫”√ÿß√—°…“ °“√∑«π Õ∫ °“√µ√«®

Õ∫§ÿ≥ ¡∫—µ‘ ·≈–°“√ Õ∫‡∑’¬∫‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åµà“ßÊ (√«¡∂÷ß§Ÿà¡◊Õ∑’Ë‡°’Ë¬«¢âÕßÕ◊Ëπ„¥Ê

∑’Ë®—¥∑”‚¥¬ºŸâº≈‘µ‡§√◊ËÕß¡◊Õ) ©∫—∫∑’Ë‡ªìπªí®®ÿ∫—π æ√âÕ¡„Àâ∫ÿ§≈“°√„™âß“π æ√âÕ¡°—∫µ“√“ß«—π‡¥◊Õπªï∑’Ë§√∫°”Àπ¥

∑«π Õ∫ ·≈–/À√◊Õ«—π‡¥◊Õπªï∑’Ë§√∫°”Àπ¥ Õ∫‡∑’¬∫

12.8 §«√‡°Á∫∫—π∑÷°°“√„™â‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ∑’Ë„™â„π°“√∑¥ Õ∫ °“√∑«π Õ∫

·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫ ‚¥¬„π∫—π∑÷°§«√ª√–°Õ∫¥â«¬¢âÕ¡Ÿ≈Õ¬à“ßπâÕ¬ ¥—ßµàÕ‰ªπ’È:

(a) ™◊ËÕ‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ

(b) ™◊ËÕºŸâº≈‘µ √ÿàπ ‡≈¢À¡“¬ª√–®”‡§√◊ËÕß À√◊Õ√À— ‡©æ“–Õ◊ËπÊ

(c) √“¬≈–‡Õ’¬¥°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘ °“√∑«π Õ∫ ·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫ (µ“¡§«“¡

‡À¡“– ¡)

(d) ∂“π∑’Ëªí®®ÿ∫—π∑’Ëµ—Èß‡§√◊ËÕß¡◊Õ (µ“¡§«“¡‡À¡“– ¡)

(e) §”·π–π”¢ÕßºŸâº≈‘µ‡§√◊ËÕß¡◊Õ (∂â“¡’) À√◊ÕÕâ“ßÕ‘ß∂÷ß∑’Ë‡°Á∫‡Õ° “√¥—ß°≈à“«

(f) «—π‡¥◊Õπªï º≈ Õ∫‡∑’¬∫ ·≈– ”‡π“√“¬ß“πº≈ °“√∑«π Õ∫ ·≈–„∫√—∫√Õß°“√ Õ∫‡∑’¬∫

∑—ÈßÀ¡¥ °“√ª√—∫·µàß ‡°≥±å°“√¬Õ¡√—∫ ·≈–«—π‡¥◊Õπªï∑’Ë°”Àπ¥°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘

°“√∑«π Õ∫ ·≈–/À√◊Õ°“√ Õ∫‡∑’¬∫„π§√—ÈßµàÕ‰ª

(g) °“√∫”√ÿß√—°…“∑’Ëºà“π¡“®π∂÷ßªí®®ÿ∫—π·≈–·ºπ°“√∫”√ÿß√—°…“ ·≈–

(h) ª√–«—µ‘°“√™”√ÿ¥ °“√∑”ß“πº‘¥ª°µ‘ °“√¥—¥·ª≈ß À√◊Õ°“√´àÕ¡·´¡ πÕ°®“°π’È¬—ß·π–π”

„Àâ‡°Á∫∫—π∑÷°¢âÕ¡Ÿ≈„π√–À«à“ß°“√„™âß“π¥â«¬

12.9 ¢—ÈπµÕπ°“√¥”‡π‘πß“π§«√√«¡∂÷ß§”·π–π”‡°’Ë¬«°—∫§«“¡ª≈Õ¥¿—¬„π°“√®—¥°“√ °“√‡§≈◊ËÕπ¬â“¬

·≈–°“√‡°Á∫√—°…“‡§√◊ËÕß¡◊Õ«—¥ À“°¡’°“√µ‘¥µ—Èß„À¡àÕ’°§√—Èß µâÕß∑”°“√∑∫∑«π§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ´È”

‡æ◊ËÕ„Àâ·πà„®«à“‡§√◊ËÕß¡◊Õ«—¥π—Èπ¬—ß “¡“√∂„™âß“π‰¥â¥’À≈—ß°“√µ‘¥µ—Èß

12.10 §«√®—¥∑”¢—ÈπµÕπ°“√¥”‡π‘πß“π„π°“√∫”√ÿß√—°…“‡§√◊ËÕß¡◊Õ·≈–Õÿª°√≥å ‡™àπ °“√∫”√ÿß√—°…“

µ“¡ª°µ‘‚¥¬°≈ÿà¡ºŸâ‡™’Ë¬«™“≠®“°¿“¬„π À√◊Õ¿“¬πÕ°Õß§å°√ µ“¡¥â«¬°“√∑«π Õ∫ ¡√√∂π–°“√∑”ß“π¢Õß

‡§√◊ËÕß¡◊Õ

12.11 „π°√≥’∑’Ë‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ ¡’°“√„™âß“π¡“°‡°‘π‰ª À√◊Õ„™âß“πÕ¬à“ß

‰¡à∂Ÿ°µâÕß „Àâº≈°“√µ√«®«‘‡§√“–Àå∑’Ëπà“ ß —¬ À√◊Õ· ¥ß„Àâ‡ÀÁπ«à“¡’¢âÕ∫°æ√àÕß À√◊Õ„Àâ§à“∑’ËÕÕ°πÕ°™à«ß∑’Ë°”Àπ¥

§«√ß¥„™âß“π·≈–µ‘¥©≈“°·®âß„Àâ™—¥‡®π À“°‡ªìπ‰ª‰¥â§«√ß¥„™â‡§√◊ËÕß¡◊Õπ—Èπ®π°«à“®–‰¥â√—∫°“√´àÕ¡·´¡ À√◊Õ

µ√«® Õ∫§ÿ≥ ¡∫—µ‘ È”



54

12.12 When the equipment, instruments and other devices are outside the direct controlof the laboratory for a certain period or have undergone major repair, the laboratory shouldrequalify the equipment to ensure its suitability for use.

Note: For further guidance on calibration, verification of performance and qualificationof equipment refer to:

ë Procedures for verifying and calibrating refractometers, thermometers used indeterminations of melting temperatures and potentiometers for pH determinationsand methods for verifying the reliability of scales for ultraviolet and infraredspectrophotometers and spectrofluorometers in The International Pharmacopoeia (19);

ë Specific guidelines for qualification of equipment elaborated by the European Networkof Official Medicines Control Laboratories (OMCL) (20); and

ë General chapter of the US Pharmacopeia on Analytical instrument qualification (21).

13. Traceability

13.1 The result of an analysis should be traceable, when appropriate, ultimately to aprimary reference substance.

13.2 All calibrations or qualification of instruments should be traceable to certifiedreference materials and to SI units (metrological traceability).

Part Three. Working procedures

14. Incoming samples

Sections 14.1-14.3 are applicable to national pharmaceutical quality control laboratories.

14.1 Samples received by a laboratory may be for compliance testing or for investigativetesting. Samples for compliance testing include routine samples for control, samples suspectedof not complying with the specifications or samples submitted in connection with a marketingauthorization process. Close collaboration with the providers of the samples is important. Inparticular it is important that the sample is large enough to enable, if required, a number ofreplicate tests to be carried out (see Part three, section 14.3) and for part of the sample to beretained (see Part three, section 20).


55À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

12.12 „π°√≥’‡§√◊ËÕß¡◊Õ ‡§√◊ËÕß¡◊Õ«—¥ ·≈–Õÿª°√≥åÕ◊ËπÊ Õ¬ŸàπÕ°‡Àπ◊Õ°“√§«∫§ÿ¡‚¥¬µ√ß¢Õß

ÀâÕßªØ‘∫—µ‘°“√„π™à«ß√–¬–‡«≈“Àπ÷Ëß À√◊Õºà“π°“√´àÕ¡·´¡§√—Èß„À≠à ÀâÕßªØ‘∫—µ‘°“√§«√∑”°“√∑∫∑«π§ÿ≥ ¡∫—µ‘

¢Õß‡§√◊ËÕß¡◊Õπ—Èπ ‡æ◊ËÕ„Àâ·πà„®«à“‡§√◊ËÕß¡◊Õπ—Èπ “¡“√∂„™âß“π‰¥âµ“¡ª°µ‘

À¡“¬‡Àµÿ: “¡“√∂»÷°…“·π«∑“ß ”À√—∫°“√ Õ∫‡∑’¬∫ °“√∑«π Õ∫ ¡√√∂π–°“√∑”ß“π·≈–°“√

µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ‡æ‘Ë¡‡µ‘¡‰¥â∑’Ë

ë Procedures for verifying and calibrating refractometers, thermometers used in

determinations of melting temperatures and potentiometers for pH determinations and

methods for verifying the reliability of scales for ultraviolet and infrared spectrophotometers

and spectrofluorometers in The International Pharmacopoeia (19);

ë Specific guidelines for qualification of equipment elaborated by the European Network

of Official Medicines Control Laboratories (OMCL) (20); and

ë General Chapter of the US Pharmacopoeia on Analytical Instrument Qualification (21)

13. °“√ Õ∫°≈—∫‰¥â

13.1 º≈°“√«‘‡§√“–Àå§«√ Õ∫°≈—∫‰¥âµ“¡§«“¡‡À¡“– ¡®π∂÷ß “√¡“µ√∞“πª∞¡¿Ÿ¡‘

13.2 °“√ Õ∫‡∑’¬∫À√◊Õ°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß‡§√◊ËÕß¡◊Õ∑ÿ°™π‘¥ §«√ Õ∫°≈—∫‰¥â∂÷ß«— ¥ÿÕâ“ßÕ‘ß

√—∫√Õß ·≈– SI units (°“√ Õ∫°≈—∫‰¥â∑“ß¡“µ√«‘∑¬“)

à«π∑’Ë 3 ¢—ÈπµÕπ°“√ªØ‘∫—µ‘ß“π

14. µ—«Õ¬à“ß∑’Ë‰¥â√—∫

¢âÕ 14.1 - 14.3 “¡“√∂π”‰ª„™â°—∫ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å√–¥—∫™“µ‘

14.1 ÀâÕßªØ‘∫—µ‘°“√‰¥â√—∫µ—«Õ¬à“ß‡æ◊ËÕ∑¥ Õ∫µ“¡¢âÕ°”Àπ¥∑’Ë‡ªìπ¡“µ√∞“π À√◊Õ∑¥ Õ∫‡æ◊ËÕπ”º≈

‰ª¥”‡π‘π°“√µ“¡°ÆÀ¡“¬ °“√∑¥ Õ∫µ“¡¢âÕ°”Àπ¥∑’Ë‡ªìπ¡“µ√∞“πª√–°Õ∫¥â«¬µ—«Õ¬à“ß∑—Ë«‰ª∑’Ë∑¥ Õ∫

‡æ◊ËÕ§«∫§ÿ¡§ÿ≥¿“æ µ—«Õ¬à“ß∑’Ë ß —¬«à“‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥ À√◊Õµ—«Õ¬à“ß∑’Ë∑¥ Õ∫‡æ◊ËÕ·π∫º≈∑¥ Õ∫

”À√—∫°“√¢ÕÕπÿ≠“µ®”Àπà“¬¬“ °“√ª√– “π√à«¡¡◊Õ°—∫ºŸâ àßµ—«Õ¬à“ßÕ¬à“ß„°≈â™‘¥π—∫‡ªìπ ‘Ëß ”§—≠ ‚¥¬‡©æ“–

µ—«Õ¬à“ß∑’Ë‰¥â√—∫¡’ª√‘¡“≥∑’Ë¡“°‡æ’¬ßæÕµàÕ°“√«‘‡§√“–Àå´È”∂â“µâÕß°“√ (¥Ÿ à«π∑’Ë 3 ¢âÕ 14.3) ·≈–‡°Á∫µ—«Õ¬à“ß

‰«â∫“ß à«π‡¡◊ËÕ ‘Èπ ÿ¥°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 3 ¢âÕ 20)



56

14.2 Samples for investigative testing may be submitted by various sources includingcustoms, police and medicines inspectors. These samples comprise suspicious, illegal or counterfeitsubstances or products. Usually, the primary objective of investigative testing is to identify thesubstance or the ingredient in the product and, if sufficient substance or product is available,to estimate the purity or content. Well-documented screening procedures should be in place aswell as confirmatory analytical procedures to positively identify the substance or the ingredient(s).If an estimation of the content of an identified ingredient is required then an appropriatequantitative analytical procedure should be applied. The value obtained should be reported withan indication of the uncertainty of measurement if required (see Part three, section 18.10).

14.3 It is common for a sample to be taken and divided into three approximately equalportions for submission to the laboratory:

- one for immediate testing;

- the second for confirmation of testing if required; and

- the third for retention in case of dispute.

14.4 If the laboratory is responsible for sampling of substances, materials or productsfor subsequent testing then it should have a sampling plan and an internal procedure forsampling available to all analysts and technicians working in the laboratory. Samples shouldbe representative of the batches of material from which they are taken and sampling should becarried out so as to avoid contamination and other adverse effects on quality, or mix-up of or bythe material being sampled. All the relevant data related to sampling should be recorded.

Note: Guidelines for sampling of pharmaceutical products and related materials wereadopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at itsthirty-ninth meeting (22).

Test request

14.5 A standard test request form should be filled out and should accompany eachsample submitted to the laboratory. In the case of a pharmaceutical manufacturerûs laboratorythe requirements may be given in the master production instructions.

14.6 The test request form should provide or leave space for the following information:

(a) the name of the institution or inspector that supplied the sample;

(b) the source of the material;

(c) a full description of the medicine, including its composition, internationalnonproprietary name (INN) (if available) and brand name(s);

(d) dosage form and concentration or strength, the manufacturer, the batch number(if available) and the marketing authorization number;


57À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

14.2 µ—«Õ¬à“ß∑’ËÀâÕßªØ‘∫—µ‘°“√‰¥â√—∫‡æ◊ËÕπ”º≈∑¥ Õ∫‰ª¥”‡π‘π°“√µ“¡°ÆÀ¡“¬ Õ“® àß¡“®“°∑’Ëµà“ßÊ

‡™àπ ¥à“π»ÿ≈°“°√ µ”√«® À√◊ÕºŸâµ√«® Õ∫ µ—«Õ¬à“ßÕ“®‡ªìπ “√µâÕß ß —¬À√◊Õº≈‘µ¿—≥±åª≈Õ¡ªπÀ√◊Õ

º‘¥°ÆÀ¡“¬ ¡—°¡’«—µ∂ÿª√– ß§åÀ≈—°‡æ◊ËÕπ”º≈∑¥ Õ∫‰ª¥”‡π‘π°“√µ“¡°ÆÀ¡“¬ ‚¥¬°“√æ‘ Ÿ®πå‡Õ°≈—°…≥å

µ—«¬“À√◊Õ “√„πº≈‘µ¿—≥±å ·≈–À“°¡’ “√À√◊Õº≈‘µ¿—≥±åµ—«Õ¬à“ß¡“°‡æ’¬ßæÕ Õ“®∑”°“√µ√«®À“§«“¡∫√‘ ÿ∑∏‘Ï

À√◊Õª√‘¡“≥ “√√à«¡¥â«¬ «‘∏’∑’Ë„™âµ√«® Õ∫§«√ºà“π°“√§—¥°√Õß¡“‡ªìπÕ¬à“ß¥’·≈–¡’°“√∫—π∑÷° ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“

√–∫ÿ™π‘¥¢Õß “√À√◊Õ “√ ”§—≠„πµ—«Õ¬à“ß‡ªìπ‰ªÕ¬à“ß∂Ÿ°µâÕß ·≈–À“°µâÕß°“√«‘‡§√“–Àå‡æ◊ËÕÀ“ª√‘¡“≥ “√ ”§—≠

§«√„™â¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå∑’Ë‡À¡“– ¡ §à“∑’Ë‰¥â®“°°“√«‘‡§√“–Àå §«√√–∫ÿ§à“§«“¡‰¡à·πàπÕπ¢Õß°“√«—¥

√à«¡¥â«¬∂â“µâÕß°“√ (¥Ÿ à«π∑’Ë 3 ¢âÕ 18.10)

14.3 ‚¥¬∑—Ë«‰ªµ—«Õ¬à“ß∑’Ë‰¥â√—∫®–·∫àßÕÕ°‡ªìπ 3 à«π‡∑à“Ê °—π‡æ◊ËÕ àß‰ª¬—ßÀâÕßªØ‘∫—µ‘°“√ §◊Õ

- à«π∑’Ë„™â„π°“√∑¥ Õ∫

- à«π∑’Ë„™â∑¥ Õ∫ È”‡æ◊ËÕ¬◊π¬—πº≈ (À“°®”‡ªìπ) ·≈–

- à«π∑’Ë‡°Á∫‰«â °√≥’¡’¢âÕ‚µâ·¬âß„π¿“¬À≈—ß

14.4 ∂â“ÀâÕßªØ‘∫—µ‘°“√√—∫º‘¥™Õ∫„π°“√ ÿà¡µ—«Õ¬à“ß “√ «—µ∂ÿ¥‘∫ À√◊Õº≈‘µ¿—≥±å‡æ◊ËÕπ”‰ª∑¥ Õ∫

§«√®—¥∑”·ºπ·≈–¢—ÈπµÕπ„π°“√§—¥‡≈◊Õ° ÿà¡µ—«Õ¬à“ß ”À√—∫π—°«‘‡§√“–Àå·≈–π—°‡∑§π‘§„πÀâÕßªØ‘∫—µ‘°“√

‚¥¬µ—«Õ¬à“ß∑’Ë ÿà¡‰«â§«√‡ªìπµ—«·∑π¢Õß√ÿàπ∑’Ëº≈‘µ „π¢—ÈπµÕπ°“√ ÿà¡µ—«Õ¬à“ß§«√À≈’°‡≈’Ë¬ß°“√ªπ‡ªóôÕπÀ√◊Õ°“√

°√–∑”„¥Ê ∑’Ë®– àßº≈°√–∑∫µàÕ§ÿ≥¿“æ¢Õßµ—«Õ¬à“ß À√◊Õ‡°‘¥°“√ —∫ π°—π¢Õßµ—«Õ¬à“ß∑’Ë ÿà¡ ¢âÕ¡Ÿ≈∑ÿ°Õ¬à“ß

∑’Ë‡°’Ë¬«¢âÕß°—∫°“√ ÿà¡µ—«Õ¬à“ß§«√¡’°“√∫—π∑÷°‰«â

À¡“¬‡Àµÿ: Guidelines for sampling of pharmaceutical products and related materials were

adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its

thirty-ninth meeting (22)

§”√âÕß¢Õµ√«®«‘‡§√“–Àå

14.5 §«√¡’°“√°√Õ°·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå ·≈–§«√·π∫¡“æ√âÕ¡°—∫µ—«Õ¬à“ß∑’Ë àß¡“¬—ß

ÀâÕßªØ‘∫—µ‘°“√ ·≈–„π°√≥’∑’Ë‡ªìπÀâÕßªØ‘∫—µ‘°“√«‘‡§√“–Àå¢Õß‚√ßß“πºŸâº≈‘µ¬“ ¢âÕ°”Àπ¥¡“µ√∞“πÕ“®Õ¬Ÿà„π

µâπ©∫—∫¢Õß«‘∏’°“√º≈‘µ (master production instructions)

14.6 ·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå §«√ª√–°Õ∫¥â«¬:

(a) ™◊ËÕÀπà«¬ß“πÀ√◊ÕºŸâµ√«® Õ∫∑’Ë®—¥ àßµ—«Õ¬à“ß

(b) ·À≈àß∑’Ë¡“¢Õß«— ¥ÿ

(c) √“¬≈–‡Õ’¬¥¢Õßµ—«Õ¬à“ß¬“ ´÷Ëßª√–°Õ∫¥â«¬ à«πª√–°Õ∫ International Nonproprietary

Name À√◊Õ INN (∂â“¡’) ·≈–™◊ËÕ°“√§â“

(d) √Ÿª·∫∫¬“·≈–§«“¡‡¢â¡¢âπÀ√◊Õ§«“¡·√ß¢Õß¬“ ºŸâº≈‘µ ‡≈¢√ÿàπ∑’Ëº≈‘µ (∂â“¡’) ·≈– ‡≈¢∑–‡∫’¬π

µ”√—∫¬“



58

(e) the size of the sample;

(f) the reason for requesting the analysis;

(g) the date on which the sample was collected;

(h) the size of the consignment from which it was taken, when appropriate;

(i) the expiry date (for pharmaceutical products) or retest date (for APIs andpharmaceutical excipients);

(j) the specification to be used for testing;

(k) a record of any further comments (e.g. discrepancies found or associated hazard);and

(l) the required storage conditions.

14.7 The laboratory should review the test request to ensure that:

(a) the requirements are adequately defined and the laboratory has the capabilityand resources to meet them; and

(b) the appropriate tests and/or methods are selected and are capable of meetingcustomersû requirements.

Any issue should be resolved with the originator of the request for analysis beforetesting starts and a record of the review should be kept.

Registration and labelling

14.8 All newly delivered samples and accompanying documents (e.g. the test request)should be assigned a registration number. Separate registration numbers should be assignedto requests referring to two or more medicines, different dosage forms, or different batchesof the same medicine or different sources of the same batch. If applicable, a unique registrationnumber should also be assigned to any incoming retained sample (see Part three, section 20).

14.9 A label bearing the registration number should be affixed to each container of thesample. Care should be taken to avoid obscuring any other markings or inscriptions.

14.10 A register should be kept, which may be a record book, a card file or data-processingequipment, in which the following information is recorded:

(a) the registration number of the sample;

(b) the date of receipt; and

(c) the specific unit to which the sample was forwarded.


59À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

(e) ª√‘¡“≥µ—«Õ¬à“ß

(f) «—µ∂ÿª√– ß§å„π°“√¢Õµ√«®«‘‡§√“–Àå

(g) «—π‡¥◊Õπªï∑’Ë‡°Á∫µ—«Õ¬à“ß

(h) ª√‘¡“≥µ—«Õ¬à“ß∑’Ë®—¥ àß µ“¡§«“¡‡À¡“– ¡

(i) «—π ‘ÈπÕ“¬ÿ ( ”À√—∫‡¿—™¿—≥±å) À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à ( ”À√—∫µ—«¬“ ”§—≠ ·≈– “√

ª√ÿß·µàß¬“)

(j) ¢âÕ°”Àπ¥„π°“√µ√«®«‘‡§√“–Àå

(k) ¢âÕ¡Ÿ≈‡æ‘Ë¡‡µ‘¡µà“ßÊ (‡™àπ ≈—°…≥–º‘¥ª°µ‘∑’Ëæ∫ Õ—πµ√“¬µà“ßÊ ∑’Ë‡°’Ë¬«¢âÕß) ·≈–

(l) ¿“«–„π°“√‡°Á∫µ—«Õ¬à“ß

14.7 ÀâÕßªØ‘∫—µ‘°“√§«√∑∫∑«π§”√âÕß¢Õµ√«®«‘‡§√“–Àå ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“

(a) ¡’°“√√–∫ÿ¢âÕ°”Àπ¥µà“ßÊ Õ¬à“ß‡æ’¬ßæÕ ·≈–ÀâÕßªØ‘∫—µ‘°“√¡’»—°¬¿“æ·≈–∑√—æ¬“°√∑’Ë®–

“¡“√∂ªØ‘∫—µ‘µ“¡‰¥â ·≈–

(b) ‡≈◊Õ°„™â«‘∏’«‘‡§√“–Àå∑’Ë¡’§«“¡‡À¡“– ¡·≈– “¡“√∂«‘‡§√“–Àå‰¥âµ“¡§«“¡µâÕß°“√¢Õß≈Ÿ°§â“

§«√¡’°“√µ°≈ß°—π„πª√–‡¥Áπµà“ßÊ °—∫ºŸâ√âÕß¢Õµ√«®«‘‡§√“–Àå·≈–§«√°√–∑”°àÕπ∑’Ë®–‡√‘Ë¡∑”

°“√∑¥ Õ∫·≈–§«√‡°Á∫∫—π∑÷°º≈°“√µ√«® Õ∫§”√âÕß¢Õµ√«®«‘‡§√“–Àå‰«â

°“√≈ß∑–‡∫’¬π√—∫µ—«Õ¬à“ß·≈–°“√µ‘¥‡§√◊ËÕßÀ¡“¬™’È∫àßµ—«Õ¬à“ß

14.8 µ—«Õ¬à“ß∑’Ë‰¥â√—∫„À¡à∑—ÈßÀ¡¥ æ√âÕ¡‡Õ° “√·π∫ (‡™àπ ·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå) §«√√–∫ÿ

‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß À“°µ—«Õ¬à“ß∑’Ë‰¥â√—∫¡“¡’¡“°°«à“ 1 µ—«Õ¬à“ß À√◊ÕÕ“®¡’√Ÿª·∫∫¬“∑’Ë·µ°µà“ß°—π À√◊Õ

√ÿàπº≈‘µµà“ß°—π À√◊Õ√ÿàπº≈‘µ‡¥’¬«°—π·µà„™â«—µ∂ÿ¥‘∫®“°§π≈–·À≈àß §«√√–∫ÿ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ßµà“ß°—π À“°

‡ªìπ‰ª‰¥â §«√√–∫ÿ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß‡¥’¬«°—ππ’È°—∫µ—«Õ¬à“ß∑’Ë‡°Á∫‰«âÀ≈—ß°“√«‘‡§√“–Àå¥â«¬ (¥Ÿ à«π∑’Ë 3 ¢âÕ 20)

14.9 §«√ª√–∑—∫‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß≈ß∫π∑ÿ°¿“™π–∫√√®ÿµ—«Õ¬à“ß §«√√–«—ß‰¡à„Àâ≈∫‡≈◊Õπ À√◊Õ

¡’√Õ¬¢’¥¶à“

14.10 §«√∫—π∑÷°¢âÕ¡Ÿ≈°“√√—∫µ—«Õ¬à“ß‚¥¬°“√∫—π∑÷°≈ß„π ¡ÿ¥À√◊Õ‡§√◊ËÕß¡◊Õ°“√‡°Á∫¢âÕ¡Ÿ≈Õ◊ËπÊ ‚¥¬

¢âÕ¡Ÿ≈∑’Ë‡°Á∫∫—π∑÷°ª√–°Õ∫¥â«¬:

(a) ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß

(b) «—π‡¥◊Õπªï√—∫µ—«Õ¬à“ß ·≈–

(c) ®”π«πµ—«Õ¬à“ß∑’Ë‰¥â√—∫ (√–∫ÿÀπà«¬)



60

Visual inspection of the submitted sample

14.11 The sample received should be visually inspected by laboratory staff to ensure thatthe labelling conforms with the information contained in the test request. The findings shouldbe recorded, dated and signed. If discrepancies are found, or if the sample is obviously damaged,this fact should be recorded without delay on the test request form. Any queries should beimmediately referred back to the provider of the sample.

Storage

14.12 The sample prior to testing, the retained sample (see Part three, section 20) andany portions of the sample remaining after performance of all the required tests should bestored safely, taking into account the storage conditions (22, 23) specified for the sample.

Forwarding to testing

14.13 The specific unit to which the sample is sent for testing is determined by theperson responsible.

14.14 The examination of a sample should not be started before the relevant test requesthas been received.

14.15 The sample should be properly stored until all relevant documentation has beenreceived.

14.16 A request for analysis may be accepted verbally only in emergencies. All detailsshould immediately be placed on record pending the receipt of written confirmation.

14.17 Unless a computerized system is used, copies or duplicates of all documentationshould accompany each numbered sample when sent to the specific unit.

14.18 Testing should be performed as described under Part three, section 17.

15. Analytical worksheet

15.1 The analytical worksheet is an internal document to be used by the analyst forrecording information about the sample, the test procedure, calculations and the results of testing.It is to be complemented by the raw data obtained in the analysis.

Purpose

15.2 The analytical worksheet contains documentary evidence either:

- to confirm that the sample being examined is in accordance with the requirements; or

- to support an OOS result (see Part three, sections 18.1 - 18.3).


61À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

°“√µ√«® Õ∫µ—«Õ¬à“ß∑’Ë‰¥â√—∫‚¥¬°“√¡Õß¥â«¬µ“

14.11 ºŸâªØ‘∫—µ‘ß“π„πÀâÕßªØ‘∫—µ‘°“√§«√µ√«® Õ∫µ—«Õ¬à“ß∑’Ë‰¥â√—∫«à“¡’§«“¡º‘¥ª°µ‘„¥Ê À√◊Õ‰¡à‚¥¬

°“√µ√«®¥Ÿ¥â«¬µ“ ‡æ◊ËÕ„Àâ¡—Ëπ„®«à“¢âÕ¡Ÿ≈∑’Ë‡¢’¬πµ√ßµ“¡∑’Ë∫—π∑÷°‰«â„π·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå ·≈–

§«√≈ß∫—π∑÷°°“√µ√«®æ∫„¥Ê «—π‡¥◊Õπªï·≈–≈“¬¡◊Õ™◊ËÕºŸâµ√«® Õ∫ À“°æ∫¢âÕ¢—¥·¬âßÀ√◊Õæ∫«à“µ—«Õ¬à“ß∂Ÿ°∑”≈“¬

‡ ’¬À“¬ §«√≈ß∫—π∑÷°∑—π∑’„π·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå ‡¡◊ËÕæ∫¢âÕ ß —¬„¥Ê §«√µ‘¥µàÕ‚¥¬µ√ß°—∫

ºŸâ®—¥ àßµ—«Õ¬à“ß„π∑—π∑’

°“√‡°Á∫√—°…“

14.12 §«√‡°Á∫√—°…“µ—«Õ¬à“ß∑’Ë‰¥â√—∫°àÕπ°“√«‘‡§√“–Àå µ—«Õ¬à“ß∑’Ë‡°Á∫‰«âÀ≈—ß°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 3

¢âÕ 20) ·≈– à«π„¥Ê ¢Õßµ—«Õ¬à“ß∑’Ë‡À≈◊Õ®“°°“√«‘‡§√“–Àå Õ¬à“ßª≈Õ¥¿—¬„π ¿“«–∑’Ë‡À¡“– ¡µ“¡∑’Ë°”Àπ¥

”À√—∫µ—«Õ¬à“ßπ—ÈπÊ (22, 23)

°“√ àßµàÕµ—«Õ¬à“ß‡æ◊ËÕ°“√∑¥ Õ∫

14.13 ¡’∫ÿ§≈“°√∑’Ë√—∫º‘¥™Õ∫„π°“√µ—¥ ‘π„® àßµàÕµ—«Õ¬à“ß‰ª¬—ßÀπà«¬ªØ‘∫—µ‘ß“π‡©æ“–‡æ◊ËÕ∑”°“√∑¥ Õ∫

14.14 ‰¡à§«√‡√‘Ë¡∑”°“√«‘‡§√“–Àåµ—«Õ¬à“ß°àÕπ‰¥â√—∫·∫∫øÕ√å¡§”√âÕß¢Õµ√«®«‘‡§√“–Àå

14.15 §«√‡°Á∫µ—«Õ¬à“ß„π∑’Ë∑’Ë‡À¡“– ¡®π°«à“®–‰¥â√—∫‡Õ° “√∑—ÈßÀ¡¥‡√’¬∫√âÕ¬

14.16 Õ“®∑”°“√¢Õµ√«®«‘‡§√“–Àå‚¥¬«“®“„π°√≥’©ÿ°‡©‘π‡√àß¥à«π‡∑à“π—Èπ §«√≈ß∫—π∑÷°¢âÕ¡Ÿ≈∑—ÈßÀ¡¥

„π∑—π∑’·≈–¡’°“√¬◊π¬—π‡ªìπ≈“¬≈—°…≥åÕ—°…√„π¿“¬À≈—ß

14.17 „π°√≥’∑’Ë‰¡à‰¥â„™â√–∫∫§Õ¡æ‘«‡µÕ√å µ—«Õ¬à“ß∑’Ë∂Ÿ° àßµàÕ‰ª¬—ßÀπà«¬ªØ‘∫—µ‘ß“π‡©æ“– §«√¡’ ”‡π“

À√◊Õ ”‡π“§Ÿà©∫—∫¢Õß‡Õ° “√∑—ÈßÀ¡¥∑’Ë‡°’Ë¬«¢âÕß·π∫‰ªæ√âÕ¡°—π

14.18 °“√∑¥ Õ∫§«√∑”µ“¡¢—ÈπµÕπ∑’Ë√–∫ÿ‰«â„π à«π∑’Ë 3 ¢âÕ 17

15. ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå

15.1 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå À¡“¬∂÷ß ‡Õ° “√¿“¬„π∑’Ëπ—°«‘‡§√“–Àå„™â ”À√—∫∫—π∑÷°¢âÕ¡Ÿ≈

‡°’Ë¬«°—∫µ—«Õ¬à“ß ¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå °“√§”π«≥ ·≈–º≈°“√«‘‡§√“–Àå ·≈–Õ“®√«¡∂÷ß¢âÕ¡Ÿ≈¥‘∫µà“ßÊ ∑’Ë‰¥â

®“°°“√«‘‡§√“–Àå¥â«¬

«—µ∂ÿª√– ß§å

15.2 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå ª√–°Õ∫¥â«¬¢âÕ¡Ÿ≈µà“ßÊ ‡æ◊ËÕ

- ¬◊π¬—π«à“µ—«Õ¬à“ß∑’Ë‰¥â√—∫°“√«‘‡§√“–Àå‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥ À√◊Õ

- π—∫ πÿπº≈°“√«‘‡§√“–Àå∑’Ë‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥ (¥Ÿ à«π∑’Ë 3 ¢âÕ 18.1 - 18.3)



62

Use

15.3 A separate analytical worksheet should usually be used for each numbered sampleor group of samples.

15.4 Analytical worksheets from different units relating to the same sample shouldbe assembled together.

Content

15.5 The analytical worksheet should provide the following information:

(a) the registration number of the sample (see Part three, section 14.9);

(b) page numbering, including the total number of pages (and including annexes);

(c) the date of the test request;

(d) the date on which the analysis was started and completed;

(e) the name and signature of the analyst;

(f) a description of the sample received;

(g) references to the specifications and a full description of test methods by whichthe sample was tested, including the limits;

(h) the identification of the test equipment used (see Part two, section 12.1);

(i) the identification number of any reference substance used (see Part two,section 11.5);

(j) if applicable, the results of the system suitability test;

(k) the identification of reagents and solvents employed;

(l) the results obtained;

(m) the interpretation of the results and the final conclusions (whether or not the samplewas found to comply with the specifications), approved and signed by thesupervisor; and

(n) any further comments, for example, for internal information (see Part three,section 17.1), or detailed notes on the specifications selected and the methodsof assessment used (see Part three, section 15.9), or any deviation from theprescribed procedure, which should be approved and reported, or whether andwhen portions of the sample were forwarded to other units for special tests andthe date on which the results were received.


63À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

°“√„™âß“π

15.3 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå 1 ©∫—∫ §«√„™â ”À√—∫·µà≈–‡≈¢∑’Ëµ—«Õ¬à“ßÀ√◊Õ·µà≈–°≈ÿà¡µ—«Õ¬à“ß

15.4 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå ¢Õß·µà≈–Àπà«¬ß“π∑’Ë‡°’Ë¬«¢âÕß°—∫µ—«Õ¬à“ß‡¥’¬«°—π §«√‡°Á∫

√«∫√«¡‰«â¥â«¬°—π

Õß§åª√–°Õ∫

15.5 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå §«√ª√–°Õ∫¥â«¬¢âÕ¡Ÿ≈¥—ßµàÕ‰ªπ’È:

(a) ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß (¥Ÿ à«π∑’Ë 3 ¢âÕ 14.9)

(b) °“√π—∫Àπâ“´÷ËßµâÕß∫àß∫Õ°®”π«πÀπâ“∑—ÈßÀ¡¥ (√«¡∂÷ß¿“§ºπ«°)

(c) «—π‡¥◊Õπªï¬◊Ëπ§”√âÕß¢Õµ√«®«‘‡§√“–Àå

(d) «—π‡¥◊Õπªï∑’Ë‡√‘Ë¡«‘‡§√“–Àå·≈–«—π‡¥◊Õπªï∑’Ë«‘‡§√“–Àå·≈â«‡ √Á®

(e) ™◊ËÕ·≈–≈“¬¡◊Õ™◊ËÕ¢Õßπ—°«‘‡§√“–Àå

(f) √“¬≈–‡Õ’¬¥µ—«Õ¬à“ß∑’Ë‰¥â√—∫

(g) °“√Õâ“ßÕ‘ß∂÷ß¢âÕ°”Àπ¥¡“µ√∞“π·≈–√“¬≈–‡Õ’¬¥«‘∏’«‘‡§√“–Àå∑’Ë„™â∑¥ Õ∫√«¡∑—Èßæ‘°—¥ (limits)

(h) √–∫ÿ‡§√◊ËÕß¡◊Õ∑’Ë„™â„π°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 2 ¢âÕ 12.1)

(i) ‡≈¢√À— ‡©æ“–¢Õß “√Õâ“ßÕ‘ßµà“ßÊ ∑’Ë„™â„π°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 2 ¢âÕ 11.5)

(j) º≈°“√∑¥ Õ∫§«“¡‡À¡“– ¡¢Õß√–∫∫ (∂â“¡’)

(k) ¢âÕ¡Ÿ≈√–∫ÿ “√∑”ªØ‘°‘√‘¬“·≈–µ—«∑”≈–≈“¬∑’Ë„™â

(l) º≈°“√«‘‡§√“–Àå∑’Ë‰¥â

(m) °“√·ª≈º≈°“√«‘‡§√“–Àå·≈–¢âÕ √ÿª (‰¡à«à“µ—«Õ¬à“ß®–‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥¡“µ√∞“πÀ√◊Õ‰¡à)

¡’°“√¬Õ¡√—∫·≈–≈ß≈“¬¡◊Õ™◊ËÕ√—∫√Õß‚¥¬À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√ ·≈–

(n) ¢âÕ§‘¥‡ÀÁπ·≈–¢âÕ‡ πÕ·π–Õ◊ËπÊ ‡™àπ ¢âÕ¡Ÿ≈¿“¬„π (¥Ÿ à«π∑’Ë 3 ¢âÕ 17.1) À√◊Õ√“¬≈–‡Õ’¬¥

‡°’Ë¬«°—∫¢âÕ°”Àπ¥¢Õß«‘∏’«‘‡§√“–Àå∑’Ë‡≈◊Õ°„™â ·≈–«‘∏’°“√ª√–¡«≈º≈∑’Ë„™â (¥Ÿ à«π∑’Ë 3 ¢âÕ 15.9)

À√◊Õ§«“¡°“√‡∫’Ë¬ß‡∫π„¥Ê ®“°«‘∏’∑’Ë°”Àπ¥ ÷Ëß§«√‰¥â√—∫°“√Õπÿ¡—µ‘·≈–√“¬ß“π À√◊Õ¢âÕ¡Ÿ≈

°“√ àßµ—«Õ¬à“ß‰ª«‘‡§√“–ÀåµàÕ∑’ËÀπà«¬ß“πÕ◊Ëπ ‡æ◊ËÕ°“√∑¥ Õ∫∑’Ë‡©æ“–‡®“–®ß·≈–«—π‡¥◊Õπªï∑’Ë

‰¥â√—∫º≈°“√«‘‡§√“–Àå



64

15.6 All values obtained from each test, including blank results, should immediatelybe entered on the analytical worksheet and all graphical data, whether obtained from recordinginstruments or plotted by hand, should be attached or be traceable to an electronic record fileor document where the data are available.

15.7 The completed analytical worksheet should be signed by the responsible analyst(s),verified and approved and signed by the supervisor.

15.8 When a mistake is made in an analytical worksheet or when dataor text needto be amended, the old information should be deleted by putting a single line through it (it shouldnot be erased or made illegible) and the new information added alongside. All such alterationsshould be signed by the person making the correction and the date of the change inserted.The reason for the change should also be given on the worksheet (suitable procedures should bein place for amending electronic worksheets).

Selection of the specifications to be used

15.9 The specification necessary to assess the sample may be that given in the testrequest or master production instructions. If no precise instruction is given, the specification in theofficially recognized national pharmacopoeia may be used or, failing this, the manufacturerûsofficially approved or other nationally recognized specification. If no suitable method is available:

(a) the specification contained in the marketing authorization or product licence maybe requested from the marketing authorization holder or manufacturer and verifiedby the laboratory; or

(b) the requirements may be set by the laboratory itself on the basis of publishedinformation and any procedure employed is to be validated by the testinglaboratory (see Part three, section 16).

15.10 For official specifications the current version of the relevant pharmacopoeia shouldbe available.

Filing

15.11 The analytical worksheet should be kept safely together with any attachments,including calculations and recordings of instrumental analyses.


65À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

15.6 §«√∫—π∑÷°§à“∑—ÈßÀ¡¥∑’Ë‰¥â®“°°“√«‘‡§√“–Àå √«¡∑—Èß§à“·∫≈ß§å ≈ß„π·ºàπ∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå

∑—π∑’ ·≈–·π∫¢âÕ¡Ÿ≈∑’Ë‡ªìπ√Ÿª°√“ø∑—ÈßÀ¡¥∑’Ë‰¥â®“°‡§√◊ËÕß¡◊Õ À√◊Õ®“°°“√æ≈ÁÕµ¥â«¬¡◊Õ À√◊Õ “¡“√∂ Õ∫°≈—∫

‰ª¬—ß‰ø≈å¢âÕ¡Ÿ≈Õ‘‡≈Á°∑√Õπ‘° åÀ√◊Õ‡Õ° “√∑’Ë∑”°“√∫—π∑÷°¢âÕ¡Ÿ≈‡À≈à“π’È‰«â‰¥â

15.7 ·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå∑’Ë ¡∫Ÿ√≥å§«√¡’≈“¬¡◊Õ™◊ËÕ¢Õßπ—°«‘‡§√“–Àå∑’Ë√—∫º‘¥™Õ∫°”°—∫Õ¬Ÿà

·≈–¡’°“√∑«π Õ∫ °“√¬Õ¡√—∫·≈–≈ß≈“¬¡◊Õ™◊ËÕ√—∫√Õß‚¥¬À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√

15.8 „π°√≥’∑’Ë¡’¢âÕº‘¥æ≈“¥„π·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå À√◊Õ‡¡◊ËÕµâÕß°“√·°â‰¢ª√—∫ª√ÿß

¢âÕ¡Ÿ≈À√◊Õ¢âÕ§«“¡ „Àâ·°â‰¢‚¥¬°“√¢’¥¶à“¢âÕ§«“¡‡°à“ÕÕ° ‚¥¬„™â‡ âπ¢’¥¶à“‡ âπ‡¥’¬« (Àâ“¡≈∫ÕÕ°À√◊Õ∑”°“√„¥Ê

„Àâ‰¡à “¡“√∂Õà“π‰¥â) ·≈â«‡¢’¬π¢âÕ§«“¡„À¡à≈ß‰ª¢â“ß¢âÕ§«“¡‡°à“ ∑—Èßπ’È°“√·°â‰¢À√◊Õ‡ª≈’Ë¬π·ª≈ß„¥Ê §«√¡’

≈“¬¡◊Õ™◊ËÕ¢ÕßºŸâ∑”°“√·°â‰¢°”°—∫Õ¬Ÿà ·≈–√–∫ÿ«—π‡¥◊Õπªï∑’Ë∑”°“√·°â‰¢ πÕ°®“°π’È§«√√–∫ÿ “‡Àµÿ∑’Ë·°â‰¢„π

·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√µ√«®«‘‡§√“–Àå (§«√°”Àπ¥À≈—°ªØ‘∫—µ‘„π°“√·°â‰¢ª√—∫ª√ÿß„π°√≥’∑’Ë·ºàπß“π∫—π∑÷°

¢âÕ¡Ÿ≈°“√«‘‡§√“–ÀåÕ¬Ÿà„π√Ÿª¢Õß‡Õ° “√Õ‘‡≈Á°∑√Õπ‘° å‰«â¥â«¬)

°“√‡≈◊Õ°„™â¢âÕ°”Àπ¥¡“µ√∞“π‡æ◊ËÕ°“√µ√«®«‘‡§√“–Àå

15.9 ¢âÕ°”Àπ¥¡“µ√∞“π∑’Ë„™â„π°“√ª√–‡¡‘πµ—«Õ¬à“ß Õ“®„Àâ¡“æ√âÕ¡°—∫·∫∫øÕ√å¡§”√âÕß¢Õµ√«®

«‘‡§√“–Àå À√◊Õ¢âÕ¡Ÿ≈§”·π–π”¢ÕßºŸâº≈‘µ À“°‰¡à¡’√–∫ÿ‰«â Õ“®„™â¢âÕ°”Àπ¥¡“µ√∞“π¢Õßµ”√“¬“·Ààß™“µ‘ ∑’Ë‡ªìπ

∑’Ë¬Õ¡√—∫Õ¬à“ß‡ªìπ∑“ß°“√ À√◊ÕÀ“°µ”√“¬“¡‘‰¥â√–∫ÿ‰«â Õ“®„™â¢âÕ°”Àπ¥¡“µ√∞“π¢ÕßºŸâº≈‘µ∑’Ë‰¥â√—∫°“√

¬Õ¡√—∫Õ¬à“ß‡ªìπ∑“ß°“√ À√◊Õ¢âÕ°”Àπ¥¡“µ√∞“π∑’Ë‰¥â√—∫°“√¬Õ¡√—∫√–¥—∫™“µ‘Õ◊Ëπ °√≥’∑’Ë‰¡à¡’«‘∏’∑’Ë‡À¡“– ¡„Àâ

¥”‡π‘π°“√ ¥—ßπ’È:

(a) “¡“√∂¢Õ¢âÕ°”Àπ¥¡“µ√∞“π¢Õßº≈‘µ¿—≥±å∑’Ë‰¥â√—∫°“√Õπÿ¡—µ‘·≈â« ®“°Àπà«¬ß“π∑’Ë¡’Õ”π“®

√—∫º‘¥™Õ∫À√◊ÕºŸâº≈‘µ ·≈–∑«π Õ∫‚¥¬ÀâÕßªØ‘∫—µ‘°“√ À√◊Õ

(b) ÀâÕßªØ‘∫—µ‘°“√ “¡“√∂°”Àπ¥¡“µ√∞“π¢÷Èπ‰¥â‡Õß∫πæ◊Èπ∞“π¢Õß¢âÕ¡Ÿ≈∑’Ë‰¥â√—∫°“√µ’æ‘¡æå·≈â«

·≈–®–µâÕßºà“π°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß°“√«‘‡§√“–Àå‚¥¬ÀâÕßªØ‘∫—µ‘°“√∑¥ Õ∫ (¥Ÿ à«π∑’Ë

3 ¢âÕ 16)

15.10 ”À√—∫¢âÕ°”Àπ¥¡“µ√∞“π∑’Ë‰¥â√—∫°“√√—∫√ÕßÕ¬à“ß‡ªìπ∑“ß°“√ §«√„™âµ“¡µ”√“¬“∑’Ë‡°’Ë¬«¢âÕß

©∫—∫ªí®®ÿ∫—π

°“√®—¥‡°Á∫‡Õ° “√

15.11 §«√‡°Á∫·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå ‡Õ° “√·π∫µà“ßÊ √«¡∑—Èß¢âÕ¡Ÿ≈°“√§”π«≥·≈–¢âÕ¡Ÿ≈

®“°‡§√◊ËÕß¡◊Õ«‘‡§√“–Àå‰«â¥â«¬°—π·≈–Õ¬Ÿà„π∑’Ëª≈Õ¥¿—¬



66

16. Validation of analytical procedures

16.1 All analytical procedures employed for testing should be suitable for the intended use.This is demonstrated by validation (24). Validation also serves to establish acceptance criteriafor system suitability tests which are subsequently employed for the verification of the analyticalprocedure before analysis.

16.2 Validation should be performed according to a validation protocol, which includesanalytical performance characteristics to be verified for various types of analytical procedures.Typical characteristics which should be considered are listed in Table 1 (in the developmentphase of an analytical procedure, robustness, i.e. the ability of the procedure to provide resultsof acceptable accuracy and precision under a variety of conditions should also be considered).The results are to be documented in the validation report.

Type of analytical

Procedure

Table 1. Characteristics to consider during validation of analytical procedures

Identification Testing for impurities

Quantitative

tests

ë dissolution

(measure-

ment only)

ë content/

potency

Assay

Limit tests

Characteristics

Accuracy - + - +

Precision

Repeatability - + - +

Intermediate precisiona - + - +

Specificity + + + +

Detection limit - -b + -

Quantitation limit - + - -

Linearity - + - +

Range - + - +

- Characteristic is normally not evaluated.+ Characteristic should normally be evaluated.a In cases where a reproducibility study has been performed, intermediate precision is not needed.b May be needed in some cases.


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16. °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß¢—ÈπµÕπ°“√«‘‡§√“–Àå

16.1 ¢—ÈπµÕπ°“√«‘‡§√“–Àå∑—ÈßÀ¡¥∑’Ëπ”¡“„™â∑¥ Õ∫ §«√‡ªìπ«‘∏’∑’Ë‡À¡“– ¡µ“¡«—µ∂ÿª√– ß§å´’Ëß· ¥ß‰¥â

‚¥¬°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß«‘∏’ (24) ∑’Ë¡’°“√°”Àπ¥§à“°“√¬Õ¡√—∫ ”À√—∫°“√∑¥ Õ∫§«“¡‡À¡“– ¡¢Õß

√–∫∫´÷Ëß„™â ”À√—∫°“√∑«π Õ∫¢—ÈπµÕπ°“√«‘‡§√“–Àå °àÕπ∑”°“√«‘‡§√“–Àå·µà≈–§√—Èß

16.2 °“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß §«√ªØ‘∫—µ‘µ“¡√–‡∫’¬∫«‘∏’°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß´÷Ëßª√–°Õ∫¥â«¬

À—«¢âÕµà“ßÊ ∑’Ë§«√∑¥ Õ∫µ“¡§«“¡‡À¡“– ¡ ”À√—∫·µà≈–¢—ÈπµÕπ¢Õß°“√µ√«®«‘‡§√“–Àå À—«¢âÕ∑’Ë§«√∑¥ Õ∫

· ¥ß„πµ“√“ß∑’Ë 1 („π¢—ÈπµÕπ°“√æ—≤π“«‘∏’«‘‡§√“–Àå √«¡∑—Èß§«“¡§ß∑π ‡™àπ «‘∏’¥”‡π‘π°“√∑’Ë “¡“√∂„Àâ§à“§«“¡

·¡àπ·≈–§«“¡‡∑’Ë¬ßÕ¬Ÿà„π‡°≥±å∑’Ë¬Õ¡√—∫¿“¬„µâ ¿“«–°“√∑’Ë·µ°µà“ß) ·≈–§«√®—¥∑”√“¬ß“πº≈°“√µ√«® Õ∫

§«“¡∂Ÿ°µâÕß¥â«¬

Type of analytical

Procedure

µ“√“ß∑’Ë 1 Characteristics to consider during validation of analytical procedures

Type of analytical Procedure

Identification Testing for impurities

Quantitative

tests

ë dissolution

(measure-

ment only)

ë content/

potency

Assay

Limit tests

Characteristics

Accuracy - + - +

Precision

Repeatability - + - +

Intermediate precisiona - + - +

Specificity + + + +

Detection limit - -b + -

Quantitation limit - + - -

Linearity - + - +

Range - + - +

- Characteristic is normally not evaluated.+ Characteristic should normally be evaluated.a In cases where a reproducibility study has been performed, intermediate precision is not needed.b May be needed in some cases.



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16.3 Pharmacopoeial methods are considered to be validated for the intended use asprescribed in the monograph(s). However, the laboratory should also confirm that, for example,for a particular finished pharmaceutical product (FPP) examined for the first time, no interferencearises from the excipients present, or that for an API, impurities coming from a new route ofsynthesis are adequately differentiated. If the pharmacopoeial method is adapted for another usethen it should be validated for such a use to demonstrate that it is fit-for-purpose.

16.4 System suitability testing is an integral part of many analytical procedures. The testsare based on the fact that the equipment, electronics, analytical operations and samples to beanalysed contribute to the system. Which system suitability tests are to be applied depends onthe type of procedure to be used. System suitability tests are employed for the verificationof pharmacopoeial methods or validated analytical procedures and should be performed prior tothe analysis. Provided the system suitability criteria are fulfilled the method or procedure isconsidered to be suitable for the intended purpose.

Note: If a large number of samples is being analysed in sequence, then appropriatesystem suitability tests are to be performed throughout the sequence to demonstrate thatthe performance of the procedure is satisfactory.

Verification is not required for basic pharmacopoeial methods such as (but not limited to)pH, loss on drying and wet chemical methods.

16.5 A major change to the analytical procedure, or in the composition of the producttested, or in the synthesis of the API, will require revalidation of the analytical procedure.

Note: Further guidance on validation of analytical procedures is available in the following:

ë Guideline elaborated by the International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use (ICH) (25);

ë Guideline elaborated by the European Network of Official Medicines ControlLaboratories (OMCL) (26);

ë General chapters of the US Pharmacopeia on Validation of compendial proceduresand on Verification of compendial procedures (27).

17. Testing

17.1 The sample should be tested in accordance with the work plan of the laboratoryafter completion of the preliminary procedures. If this is not feasible the reasons should be noted,e.g. in the analytical worksheet (see Part three, section 15), and the sample should be stored ina special place which is kept locked (see Part three, section 14.12).


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16.3 «‘∏’∑’Ë√–∫ÿ„πµ”√“¬“‰¥â√—∫°“√æ‘®“√≥“·≈â««à“ºà“π°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕßµ“¡«—µ∂ÿª√– ß§å

¢Õß°“√„™âµ“¡¡ÕπÕ°√“ø Õ¬à“ß‰√°Áµ“¡ „π§√—Èß·√°¢Õß°“√«‘‡§√“–ÀåÀâÕßªØ‘∫—µ‘°“√§«√¬◊π¬—π«à“ µ—«¬“ ”§—≠

„πµ—«Õ¬à“ß‡¿ —™¿—≥±å ”‡√Á®√Ÿª‰¡à∂Ÿ°√∫°«π®“° à«πª√–°Õ∫Õ◊ËπÊ „πµ”√—∫ À√◊Õ “√ªπ‡ªóôÕπ∑’Ë¡“®“°°√–∫«π

°“√ —ß‡§√“–Àå ‡¡◊ËÕ«‘∏’∑’Ë√–∫ÿ„πµ”√“¬“∂Ÿ°π”¡“¥—¥·ª≈ß‡æ◊ËÕ°“√„™âÕ◊Ëπ §«√¡’°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß„Àâ‡À¡“– ¡

µ“¡«—µ∂ÿª√– ß§å∑’ËµâÕß°“√

16.4 °“√∑¥ Õ∫§«“¡‡À¡“– ¡¢Õß√–∫∫‡ªìπ¢—ÈπµÕπÀπ÷Ëß„πÀ≈“¬¢—ÈπµÕπ¢Õß°“√«‘‡§√“–Àå ‚¥¬°“√

∑¥ Õ∫Õ¬Ÿà∫πæ◊Èπ∞“π¢Õß¢âÕ‡∑Á®®√‘ß∑’Ë«à“ ‡§√◊ËÕß¡◊Õ Õÿª°√≥åÕ‘‡≈Á°∑√Õπ‘° å °“√µ√«®«‘‡§√“–Àå·≈–µ—«Õ¬à“ß

∑’Ëπ”¡“µ√«®«‘‡§√“–Àåª√–°Õ∫°—π‡ªìπ√–∫∫ ÷Ëß°“√∑¥ Õ∫§«“¡‡À¡“– ¡¢Õß√–∫∫¢÷ÈπÕ¬Ÿà°—∫√Ÿª·∫∫¢—ÈπµÕπ

°“√µ√«®«‘‡§√“–Àå∑’Ë„™â °“√µ√«® Õ∫§«“¡‡À¡“– ¡¢Õß√–∫∫§«√°√–∑”°àÕπ°“√«‘‡§√“–Àå‡æ◊ËÕ∑«π Õ∫«‘∏’

«‘‡§√“–Àåµ“¡µ”√“¬“À√◊Õ«‘∏’«‘‡§√“–Àå∑’Ë‰¥â√—∫°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß·≈â« ‡°≥±å°“√∑¥ Õ∫§«“¡‡À¡“– ¡

¢Õß√–∫∫‡ªìπ ‘Ëß∑’Ë∫Õ°«à“ «‘∏’«‘‡§√“–Àåπ—Èπ‡À¡“– ¡∑’Ë®–π”‰ª„™â

À¡“¬‡Àµÿ: °√≥’«‘‡§√“–Àåµ—«Õ¬à“ß®”π«π¡“°∑’Ë°√–∑”Õ¬à“ßµàÕ‡π◊ËÕß „Àâ∑”°“√∑¥ Õ∫§«“¡‡À¡“– ¡

¢Õß√–∫∫µ≈Õ¥™à«ß‡«≈“∑’Ë«‘‡§√“–Àå ‡æ◊ËÕ· ¥ß«à“ ¡√√∂π–¢Õß√–∫∫‡ªìπ∑’Ëπà“æÕ„®

‰¡à®”‡ªìπµâÕß∑”°“√∑«π Õ∫«‘∏’«‘‡§√“–Àå ”À√—∫«‘∏’«‘‡§√“–Àåæ◊Èπ∞“π„πµ”√“¬“ (·µà‰¡à®”°—¥) ‡™àπ pH,

loss on drying ·≈– wet chemical methods

16.5 °“√‡ª≈’Ë¬π·ª≈ß∑’Ë ”§—≠„¥Ê ¢Õß¢—ÈπµÕπ°“√µ√«®«‘‡§√“–ÀåÀ√◊Õ à«πª√–°Õ∫¢Õßº≈‘µ¿—≥±å∑’Ë

∑¥ Õ∫ À√◊Õ„π¢—ÈπµÕπ°“√ —ß‡§√“–Àåµ—«¬“ ”§—≠ ®–µâÕß¡’°“√∑∫∑«π°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß«‘∏’«‘‡§√“–Àå

À¡“¬‡Àµÿ: »÷°…“·π«∑“ß°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß¢Õß«‘∏’«‘‡§√“–Àå‡æ‘Ë¡‡µ‘¡‰¥â®“°

* Guideline elaborated by the International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use (ICH) (25);

* Guideline elaborated by the European Network of Official Medicines Control Laboratories

(OMCL) (26);

* General chapters of the US Pharmacopeia on Validation of compendial procedures

and on Verification of compendial procedures (27)

17. °“√∑¥ Õ∫

17.1 °“√∑¥ Õ∫µ—«Õ¬à“ß§«√ªØ‘∫—µ‘µ“¡·ºπ°“√∑”ß“π¢ÕßÀâÕßªØ‘∫—µ‘°“√∑’Ë®—¥∑”¢÷Èπ‡∫◊ÈÕßµâπ À“°

‰¡à “¡“√∂ªØ‘∫—µ‘µ“¡‰¥â§«√™’È·®ß‡Àµÿº≈‡ªìπ≈“¬≈—°…≥åÕ—°…√ ‡™àπ√–∫ÿ„π·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå

(¥Ÿ à«π∑’Ë 3 ¢âÕ 15) ·≈–§«√‡°Á∫µ—«Õ¬à“ß‰«â„π ∂“π∑’Ë∑’Ë “¡“√∂ªî¥≈ÁÕ§‰¥â (¥Ÿ à«π∑’Ë 3 ¢âÕ 14.12)



70

17.2 Specific tests required may need to be carried out by another unit or by aspecialized external laboratory (see Part one, section 9). The responsible person should preparethe request and arrange for the transfer of the required number of units (bottles, vials or tablets)from the sample. Each of these units should bear the correct registration number. When theanalytical test report contains results of tests performed by subcontractors, these results shouldbe identified as such.

17.3 Detailed guidance on official pharmacopoeial requirements is usually given in thegeneral notices and specific monographs of the pharmacopoeia concerned. Test procedures shouldbe described in detail and should provide sufficient information to allow properly trained analyststo perform the analysis in a reliable manner. Where system suitability criteria are defined in themethod they should be fulfilled. Any deviation from the test procedure should be approved anddocumented.

18. Evaluation of test results

18.1 Test results should be reviewed and, where appropriate, evaluated statistically aftercompletion of all the tests to determine whether they are mutually consistent and if they meet thespecifications used. The evaluation should take into consideration the results of all the tests (all testdata). Whenever doubtful (atypical) results are obtained they should be investigated. The completetesting procedure needs to be checked according to the internal quality management system (see alsoPart one, section 2).

18.2 When a doubtful result (suspected OOS result) has been identified, a review of thedifferent procedures applied during the testing process is to be undertaken by the supervisor with theanalyst or technician before retesting is permitted. The following steps should be followed:

(a) confirm with the analyst or technician that the appropriate procedure(s) was (were)applied and followed correctly;

(b) examine the raw data to identify possible discrepancies;

(c) check all calculations;

(d) check that the equipment used was qualified and calibrated, and that systemsuitability tests were performed and were acceptable;

(e) ensure that the appropriate reagents, solvents and reference substances were used;

(f) confirm that the correct glassware was used; and

(g) ensure that original sample preparations are not discarded until the investigationis complete.


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17.2 °“√∑¥ Õ∫‡©æ“–µà“ßÊ Õ“®„ÀâÀπà«¬ß“πÕ◊ËπÀ√◊ÕÀâÕßªØ‘∫—µ‘°“√¢ÕßÀπà«¬ß“π¿“¬πÕ°Õß§å°√

‡ªìπºŸâ∑¥ Õ∫ (¥Ÿ à«π∑’Ë 1 ¢âÕ 9) ºŸâ√—∫º‘¥™Õ∫§«√®—¥∑”„∫§”√âÕß¢Õµ√«®«‘‡§√“–Àå·≈–®—¥‡µ√’¬¡µ—«Õ¬à“ß

∑’Ë®– àß‰ªµ√«®«‘‡§√“–Àå„Àâ‡æ’¬ßæÕ (¢«¥ ¢«¥¬“©’¥ ‡¡Á¥) ‚¥¬µ—«Õ¬à“ß·µà≈–Àπà«¬∑’Ë àß‰ª§«√¡’‡≈¢∑–‡∫’¬π

√—∫µ—«Õ¬à“ß∑’Ë∂Ÿ°µâÕß „π°√≥’¡’°“√®â“ß‡À¡“™à«ßß“π„ÀâÀπà«¬ß“πÕ◊Ëπ‡ªìπºŸâ∑”°“√∑¥ Õ∫ §«√√–∫ÿÀπà«¬ß“π

ºŸâ√—∫®â“ß∑¥ Õ∫‰«â„π√“¬ß“πº≈°“√«‘‡§√“–Àå¥â«¬

17.3 √“¬≈–‡Õ’¬¥¢Õß·π«∑“ß∑’Ëµ”√“¬“√–∫ÿ®–ª√“°ØÕ¬Ÿà„π¢âÕ°”Àπ¥∑—Ë«‰ª ·≈–¡ÕπÕ°√“ø®”‡æ“–

¢Õßµ”√“¬“∑’Ë ‡°’Ë¬«¢âÕß ¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå§«√Õ∏‘∫“¬Õ¬à“ß≈–‡Õ’¬¥ ·≈–¡’¢âÕ¡Ÿ≈‡æ’¬ßæÕ‚¥¬∑’Ë

π—°«‘‡§√“–Àå∑’Ëºà“π°“√Õ∫√¡·≈â« “¡“√∂ªØ‘∫—µ‘µ“¡‰¥âÕ¬à“ßπà“‡™◊ËÕ∂◊Õ ¢âÕÀ“°¡’°“√°”Àπ¥§«“¡‡À¡“– ¡

¢Õß√–∫∫„π«‘∏’∑’Ë√–∫ÿ‰«â §«√ªØ‘∫—µ‘µ“¡„Àâ§√∫∂â«π¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå∑’Ë¡’°“√‡∫’Ë¬ß‡∫π‰ª®“°∑’Ë°”Àπ¥

§«√‰¥â√—∫°“√µ√«® Õ∫·≈–®—¥∑”‡ªìπ‡Õ° “√

18. °“√ª√–‡¡‘πº≈°“√∑¥ Õ∫

18.1 §«√∑∫∑«πº≈∑¥ Õ∫·≈–ª√–‡¡‘π∑“ß ∂‘µ‘ (À“°‡ªìπ‰ª‰¥â) À≈—ß‡ √Á® ‘Èπ°“√∑¥ Õ∫ ‡æ◊ËÕµ√«® Õ∫

«à“«‘∏’∑¥ Õ∫∑’Ë„™â¬—ß§ß‡À¡◊Õπ‡¥‘¡ ·≈–‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥ °“√ª√–‡¡‘πµâÕßæ‘®“√≥“º≈¢Õß∑ÿ°Ê °“√∑¥ Õ∫

(∑ÿ°¢âÕ¡Ÿ≈) À“°æ∫«à“¡’º≈∑¥ Õ∫∑’Ëπà“ ß —¬À√◊Õº‘¥ª°µ‘ µâÕß‰¥â√—∫°“√ ◊∫§âπÀ“ “‡Àµÿ ¢—ÈπµÕπ°“√µ√«®«‘‡§√“–Àå

∑’Ë ¡∫Ÿ√≥åπ—Èπ§«√‰¥â√—∫°“√µ√«® Õ∫µ“¡√–∫∫∫√‘À“√®—¥°“√¥â“π§ÿ≥¿“æ¿“¬„πÕß§å°√ (¥Ÿ à«π∑’Ë 1 ¢âÕ 2)

18.2 „π°√≥’∑’Ëæ∫«à“º≈∑¥ Õ∫¡’§«“¡º‘¥ª°µ‘‡°‘¥¢÷Èπ (À√◊Õ ß —¬«à“º≈∑¥ Õ∫‰¡à‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥)

À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√·≈–π—°«‘‡§√“–ÀåÀ√◊Õπ—°‡∑§π‘§√à«¡°—πµ√«® Õ∫ ∑∫∑«πÀ“¢—ÈπµÕπ°“√«‘‡§√“–Àå∑’Ë∑”„Àâº≈

·µ°µà“ß °àÕπ®–Õπÿ¡—µ‘°“√«‘‡§√“–Àå´È” ‚¥¬§«√ªØ‘∫—µ‘¥—ßπ’È:

(a) ¬◊π¬—π°—∫π—°«‘‡§√“–Àå/π—°‡∑§π‘§«à“‰¥âªØ‘∫—µ‘µ“¡«‘∏’«‘‡§√“–Àå∑’Ë‡À¡“– ¡π—ÈπÕ¬à“ß∂Ÿ°µâÕß

(b) µ√«® Õ∫¢âÕ¡Ÿ≈¥‘∫‡æ◊ËÕÀ“§«“¡º‘¥ª°µ‘∑’Ë‡ªìπ‰ª‰¥â

(c) µ√«® Õ∫°“√§”π«≥∑—ÈßÀ¡¥

(d) µ√«® Õ∫‡§√◊ËÕß¡◊Õ∑’Ë„™â«à“¡’§ÿ≥¿“æ ºà“π°“√ Õ∫‡∑’¬∫ ·≈–¡’°“√∑¥ Õ∫§«“¡‡À¡“– ¡

¢Õß√–∫∫·≈â« «à“¡’ª√– ‘∑∏‘¿“æ·≈–ºà“π‡°≥±å°“√¬Õ¡√—∫

(e) ¡—Ëπ„®«à“‰¥â„™â “√∑”ªØ‘°‘√‘¬“ µ—«∑”≈–≈“¬ “√Õâ“ßÕ‘ß∑’Ë‡À¡“– ¡

(f) ¬◊π¬—π°“√„™â‡§√◊ËÕß·°â«∑’Ë∂Ÿ°µâÕß ·≈–

(g) ¡—Ëπ„®«à“‰¡à‰¥â∑‘Èßµ—«Õ¬à“ß‡¥‘¡∑’Ë‡µ√’¬¡‰«â ®π°«à“°“√§âπÀ“ “‡Àµÿ‰¥â¢âÕ¬ÿµ‘



72

18.3 The identification of an error which caused an aberrant result will invalidatethe result and a retest of the sample will be necessary. Doubtful results can be rejected onlyif they are clearly due to an identified error. Sometimes the outcome of the investigation isinconclusive - no obvious cause can be identified - in which case a confirmatory determinationis to be performed by another analyst who should be at least as experienced and competent inthe analytical procedure as the original analyst. A similar value would indicate an OOS result.However, further confirmation using another validated method, if available, may be advised.

18.4 An SOP should be in place for the conduct of an investigation of an OOS testresult. The SOP should give clear guidance on the number of retests allowed (based on soundstatistical principles). All investigations and their conclusions should be recorded. In the eventof an error, any corrective action taken and any preventive measure introduced should berecorded and implemented.

18.5 All individual results (all test data) with acceptance criteria should be reported.

18.6 All conclusions should be entered on the analytical worksheet (see Part three,section 15) by the analyst and signed by the supervisor.

Note: Further guidance on evaluation and reporting of test results is available in thefollowing:

ë Guideline elaborated by the US Food and Drug Administration (5);

ë Guideline elaborated by the European Network of Official Medicines ControlLaboratories (OMCL) (28).

Analytical test report

18.7 The analytical test report is a compilation of the results and states the conclusions ofthe examination of a sample. It should be:

(a) issued by the laboratory; and

(b) based on the analytical worksheet (see Part three, section 15).

18.8 Any amendments to the original analytical test report will require the issue of a newcorrected document.

18.9 Pharmacopoeial content limits are set taking into account the uncertainty ofmeasurement, and the production capability and acceptance criteria for an analytical result shouldbe predefined. Under presently applicable rules neither the pharmacopoeias nor the NMRAs requirethe value found to be expressed with its associated expanded uncertainty for compliancetesting. However, when reporting the results of investigative testing, although the primary objectiveis to identify a substance in the sample, a determination of its concentration may be alsorequested, in which case the estimated uncertainty should also be given.


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ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

18.3 °“√∫àß™’È¢âÕº‘¥æ≈“¥∑’Ë‡ªìπ “‡Àµÿ„Àâº≈°“√∑¥ Õ∫‡∫’Ë¬ß‡∫π‰ª®“°ª°µ‘ ∑”„Àâº≈∑¥ Õ∫π—Èπ

„™â‰¡à‰¥â´÷Ëß®”‡ªìπµâÕß∑”°“√∑¥ Õ∫´È” º≈«‘‡§√“–Àå∑¥ Õ∫∑’Ëπà“ ß —¬ “¡“√∂µ—¥∑‘Èß‰¥â‡©æ“–°√≥’∑’Ë “¡“√∂

Õ∏‘∫“¬‰¥â«à“‡°‘¥®“°°º‘¥æ≈“¥∑’Ë‰¥â√–∫ÿ‰«â à«π°√≥’∑’Ë‰¡à “¡“√∂ √ÿª “‡Àµÿ¢Õßº≈∑¥ Õ∫∑’Ëº‘¥ª°µ‘ „Àâ∑”°“√

«‘‡§√“–Àå´È”‡æ◊ËÕ¬◊π¬—π‚¥¬π—°«‘‡§√“–Àå§πÕ◊Ëπ∑’Ë¡’ª√– ∫°“√≥å·≈–§«“¡ “¡“√∂„π°“√«‘‡§√“–Àå‰¡àπâÕ¬°«à“

π—°«‘‡§√“–Àå§π·√° À“°§à“∑’Ë‰¥â‡À¡◊Õπ°—π· ¥ß«à“º≈∑’Ë‰¥â‰¡à‡ªìπ‰ªµ“¡‡°≥±å∑’Ë°”Àπ¥®√‘ß Õ¬à“ß‰√°Áµ“¡

·π–π”„Àâ∑”°“√µ√«® Õ∫‡æ‘Ë¡‡µ‘¡‚¥¬„™â«‘∏’Õ◊Ëπ∑’Ëºà“π°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß·≈â« (∂â“¡’)

18.4 §«√®—¥À“¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π ‡°’Ë¬«°—∫«‘∏’°“√ ◊∫À“ “‡Àµÿ¢Õßº≈°“√∑¥ Õ∫∑’Ë‰¡à‡ªìπ‰ªµ“¡

¢âÕ°”Àπ¥ ‚¥¬¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π§«√√–∫ÿ·π«∑“ß∑’Ë™—¥‡®π‡°’Ë¬«°—∫®”π«π¢Õß°“√∑¥ Õ∫ È”∑’Ë¬Õ¡√—∫

(µ“¡À≈—° ∂‘µ‘) °“√ ◊∫À“ “‡Àµÿ·≈–∫∑ √ÿª∑—ÈßÀ¡¥ §«√‰¥â√—∫°“√∫—π∑÷°‰«â ‡™àπ‡¥’¬«°—∫§«“¡º‘¥æ≈“¥∑’Ë

‡°‘¥¢÷ÈπÀ“°¡’¢âÕ·π–π” ”À√—∫°“√·°â‰¢¢âÕ∫°æ√àÕß·≈–¡’¡“µ√°“√ªÑÕß°—π„¥Ê §«√‰¥â√—∫°“√∫—π∑÷°·≈–π”‰ªªØ‘∫—µ‘

18.5 §«√√“¬ß“πº≈«‘‡§√“–Àå·µà≈–§à“∑—ÈßÀ¡¥ (¢âÕ¡Ÿ≈¢Õß°“√∑¥ Õ∫∑—ÈßÀ¡¥) æ√âÕ¡‡°≥±å°“√¬Õ¡√—∫

18.6 π—°«‘‡§√“–Àå§«√∫—π∑÷°º≈ √ÿª∑—ÈßÀ¡¥„π·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 3 ¢âÕ 15)

·≈–≈ß≈“¬¡◊Õ™◊ËÕ‚¥¬À—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√

À¡“¬‡Àµÿ : »÷°…“·π«∑“ß ”À√—∫°“√ª√–‡¡‘πº≈·≈–√“¬ß“πº≈°“√∑¥ Õ∫‡æ‘Ë¡‡µ‘¡‰¥â®“°

* Guideline elaborated by the US Food and Drug Administration (5)

* Guideline elaborated by the European Network of Official Medicines Control

Laboratories (OMCL) (28)

√“¬ß“πº≈°“√«‘‡§√“–Àå

18.7 √“¬ß“πº≈°“√«‘‡§√“–Àå À¡“¬∂÷ß °“√√«∫√«¡º≈°“√«‘‡§√“–Àå·≈–¢âÕ √ÿª¢Õß°“√µ√«®«‘‡§√“–Àå

µ—«Õ¬à“ß ´÷Ëß§«√®–

(a) ®—¥∑”‚¥¬ÀâÕßªØ‘∫—µ‘°“√ ·≈–

(b) Õâ“ßÕ‘ßµ“¡·ºàπß“π∫—π∑÷°¢âÕ¡Ÿ≈°“√«‘‡§√“–Àå (¥Ÿ à«π∑’Ë 3 ¢âÕ 15)

18.8 °“√·°â‰¢‡æ‘Ë¡‡µ‘¡®“°√“¬ß“πº≈°“√«‘‡§√“–Àå©∫—∫‡¥‘¡ §«√®—¥∑”‡ªìπ‡Õ° “√·°â‰¢‡æ‘Ë¡‡µ‘¡©∫—∫„À¡à

„Àâ∂Ÿ°µâÕß

18.9 ¡“µ√∞“π‡™‘ßª√‘¡“≥µà“ßÊ µ“¡∑’Ëµ”√“¬“°”Àπ¥¢÷Èππ—Èπ ‰¥â§”π÷ß∂÷ß§à“§«“¡‰¡à·πàπÕπ¢Õß°“√«—¥

§«“¡ “¡“√∂„π°“√º≈‘µ ·≈–‡°≥±å°“√¬Õ¡√—∫º≈°“√«‘‡§√“–Àå ∑”„Àâ∑—Èßµ”√“¬“·≈– NMRAs ‰¡àµâÕß· ¥ß§à“

§«“¡‰¡à·πàπÕπ ”À√—∫°“√∑¥ Õ∫µ“¡¢âÕ°”Àπ¥∑’Ë‡ªìπ¡“µ√∞“π ‡™àπ µ“¡µ”√“¬“ À√◊Õµ“¡∑–‡∫’¬πµ”√—∫¬“

Õ¬à“ß‰√°Áµ“¡ °“√∑¥ Õ∫‡æ◊ËÕπ”º≈‰ª¥”‡π‘π°“√µ“¡°ØÀ¡“¬ ·¡â«à“«—µ∂ÿª√– ß§åÀ≈—°„π°“√«‘‡§√“–Àå®–µâÕß°“√

‡æ◊ËÕ√–∫ÿ™π‘¥¢Õß “√„πµ—«Õ¬à“ß ·µà„π√“¬ß“πº≈°“√«‘‡§√“–ÀåÕ“®¡’°“√√âÕß¢Õ„Àâ√–∫ÿ§«“¡‡¢â¡¢âπ¢Õß “√π—Èπ¥â«¬

´÷Ëß„π°√≥’π’È§«√· ¥ß°“√ª√–¡“≥§à“§«“¡‰¡à·πàπÕπ



74

18.10 Measurement uncertainty can be estimated in a number of ways, e.g.:

(a) by preparing an uncertainty budget for each uncertainty component identified inan analytical procedure (bottom-up approach);

(b) from validation data and control charts (29); and

(c) from the data obtained from proficiency tests or collaborative trials (top-downapproach).

Note: Further guidance can be found in various guidelines (9, 10, 30, 31, 32).

Content of the analytical test report

18.11 The analytical test report should provide the following information:

(a) the laboratory registration number of the sample;

(b) the laboratory test report number;

(c) the name and address of the laboratory testing the sample;

(d) the name and address of the originator of the request for analysis;

(e) the name, description and batch number of the sample, where appropriate;

(f) an introduction giving the background to and the purpose of the investigation;

(g) a reference to the specifications used for testing the sample or a detailed descriptionof the procedures employed (sample for investigative testing), including the limits;

(h) the results of all the tests performed or the numerical results with the standarddeviation of all the tests performed (if applicable);

(i) a discussion of the results obtained;

(j) a conclusion as to whether or not the sample(s) was (were) found to be withinthe limits of the specifications used, or for a sample for investigative testing,the substance(s) or ingredient(s) identified;

(k) the date on which the test(s) was (were) completed;

(l) the signature of the head of the laboratory or authorized person;

(m) the name and address of the original manufacturer and, if applicable, those ofthe repacker and/or trader;

(n) whether or not the sample(s) complies (comply) with the requirements;

(o) the date on which the sample was received;

(p) the expiry date or retest date, if applicable; and

(q) a statement indicating that the analytical test report, or any portion thereof, cannotbe reproduced without the authorization of the laboratory.


75À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

18.10 °“√À“§à“§«“¡‰¡à·πàπÕπ¢Õß°“√«—¥ “¡“√∂∑”‰¥âÀ≈“¬«‘∏’ ‡™àπ

(a) ‚¥¬°“√®—¥∑”§à“ª√–¡“≥ ”À√—∫°“√À“§à“§«“¡‰¡à·πàπÕπ„π·µà≈–Õß§åª√–°Õ∫¢Õß¢—ÈπµÕπ

°“√«‘‡§√“–Àå (bottom-up approach)

(b) ®“°¢âÕ¡Ÿ≈°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß·≈–®“°·ºπ¿Ÿ¡‘§«∫§ÿ¡°“√µ√«®«‘‡§√“–Àå (control charts)

(29) ·≈–

(c) ®“°¢âÕ¡Ÿ≈∑’Ë‰¥â®“°°“√∑¥ Õ∫§«“¡™”π“≠ À√◊Õ °“√ªØ‘∫—µ‘°“√√à«¡°—π√–À«à“ßÀâÕßªØ‘∫—µ‘°“√

(top-down approach)

À¡“¬‡Àµÿ : »÷°…“·π«∑“ß‡æ‘Ë¡‡µ‘¡‰¥â„π§Ÿà¡◊Õµà“ßÊ (9, 10, 30, 31, 32)

‡π◊ÈÕÀ“¢Õß√“¬ß“πº≈°“√«‘‡§√“–Àå

18.11 √“¬ß“πº≈°“√«‘‡§√“–Àå §«√ª√–°Õ∫¥â«¬¢âÕ¡Ÿ≈¥—ßµàÕ‰ªπ’È:

(a) ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß¢ÕßÀâÕßªØ‘∫—µ‘°“√

(b) ‡≈¢∑’Ë¢Õß√“¬ß“πº≈°“√∑¥ Õ∫¢ÕßÀâÕßªØ‘∫—µ‘°“√

(c) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßÀâÕßªØ‘∫—µ‘°“√∑’Ë∑¥ Õ∫µ—«Õ¬à“ß

(d) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßºŸâ¬◊Ëπ§”√âÕß¢Õµ√«®«‘‡§√“–Àå

(e) ™◊ËÕ √“¬≈–‡Õ’¬¥ ·≈– ‡≈¢√ÿàπ∑’Ëº≈‘µ¢Õßµ—«Õ¬à“ß (µ“¡§«“¡‡À¡“– ¡)

(f) ∫∑π”∑’Ë°≈à“«∂÷ß§«“¡‡ªìπ¡“·≈–«—µ∂ÿª√– ß§å¢Õß°“√∑¥ Õ∫

(g) °“√Õâ“ßÕ‘ß∂÷ß¢âÕ°”Àπ¥¡“µ√∞“π∑’Ë„™â„π°“√∑¥ Õ∫µ—«Õ¬à“ß À√◊Õ√“¬≈–‡Õ’¬¥¢Õß¢—ÈπµÕπ

°“√µ√«®«‘‡§√“–Àå∑’Ë„™â ( ”À√—∫µ—«Õ¬à“ß∑’Ë àß¡“∑¥ Õ∫‡æ◊ËÕ¥”‡π‘π°“√µ“¡°ÆÀ¡“¬) √«¡∂÷ß

‡°≥±å°”Àπ¥¢Õß°“√µ√«®«‘‡§√“–Àå

(h) º≈¢Õß°“√∑¥ Õ∫∑ÿ°√“¬°“√∑’Ë∑” À√◊Õº≈∑’Ë‡ªìπµ—«‡≈¢æ√âÕ¡¥â«¬§à“‡∫’Ë¬ß‡∫π¡“µ√∞“π¢Õß

∑ÿ°°“√∑¥ Õ∫∑’Ë∑” (∂â“¡’)

(i) °“√Õ¿‘ª√“¬º≈∑¥ Õ∫

(j) ¢âÕ √ÿª«à“º≈°“√∑¥ Õ∫µ—«Õ¬à“ßÕ¬Ÿà„π‡°≥±å¡“µ√∞“π°”Àπ¥À√◊Õ‰¡à À√◊Õ«à“¡’ “√À√◊Õµ—«¬“

”§—≠µ“¡∑’Ë√–∫ÿ„Àâµ√«®‡Õ°≈—°…≥åÀ√◊Õ‰¡à ( ”À√—∫µ—«Õ¬à“ß∑’Ë àß¡“∑¥ Õ∫‡æ◊ËÕ¥”‡π‘π°“√

µ“¡°ÆÀ¡“¬)

(k) «—π‡¥◊Õπªï∑’Ë∑”°“√∑¥ Õ∫‡ √Á® ‘Èπ

(l) ≈“¬¡◊Õ™◊ËÕ¢ÕßÀ—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√À√◊ÕºŸâ¡’Õ”π“®

(m) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßºŸâº≈‘µÀ≈—° ·≈–ºŸâ·∫àß∫√√®ÿ ·≈–/À√◊Õ ºŸâ®—¥®”Àπà“¬ (∂â“¡’)

(n) º≈°“√∑¥ Õ∫µ—«Õ¬à“ß‡ªìπ‰ªµ“¡¢âÕ°”Àπ¥À√◊Õ‰¡à

(o) «—π‡¥◊Õπªï∑’Ë√—∫µ—«Õ¬à“ß

(p) «—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à (µ“¡§«“¡‡À¡“– ¡) ·≈–

(q) ¢âÕ§«“¡∑’Ë√–∫ÿ«à“√“¬ß“πº≈°“√«‘‡§√“–ÀåÀ√◊Õ à«π„¥Ê ∑’Ë‡°’Ë¬«¢âÕß ‰¡à “¡“√∂∑” È”À“°‰¡à‰¥â√—∫

Õπÿ≠“µ®“°ÀâÕßªØ‘∫—µ‘°“√



76

19. Certificate of analysis

19.1 A certificate of analysis is prepared for each batch of a substance or product andusually contains the following information:

(a) the registration number of the sample;

(b) date of receipt;

(c) the name and address of the laboratory testing the sample;

(d) the name and address of the originator of the request for analysis;

(e) the name, description and batch number of the sample where appropriate;

(f) the name and address of the original manufacturer and, if applicable, those of therepacker and/or trader;

(g) the reference to the specification used for testing the sample;

(h) the results of all tests performed (mean and standard deviation, if applicable) withthe prescribed limits;

(i) a conclusion as to whether or not the sample was found to be within the limits ofthe specification;

(j) expiry date or retest date if applicable;

(k) date on which the test(s) was (were) completed; and

(l) the signature of the head of laboratory or other authorized person.

Note: The Guideline on model certificate of analysis was adopted by the WHO ExpertCommittee on Specifications for Pharmaceutical Preparations at its thirty-sixth meeting (3).

20. Retained samples

20.1 Samples should be retained as required by the legislation or by the originator of therequest for analysis. There should be a sufficient amount of retained sample to allow at least twore-analyses. The retained sample should be kept in its final pack.


77À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

19. „∫√—∫√Õßº≈°“√«‘‡§√“–Àå

19.1 „∫√—∫√Õßº≈°“√«‘‡§√“–Àå ®—¥∑”¢÷Èπ ”À√—∫ “√À√◊Õº≈‘µ¿—≥±å·µà≈–√ÿàπº≈‘µ ‚¥¬ª√–°Õ∫¥â«¬

¢âÕ¡Ÿ≈µà“ßÊ ¥—ßµàÕ‰ªπ’È:

(a) ‡≈¢∑–‡∫’¬π√—∫µ—«Õ¬à“ß

(b) «—π‡¥◊Õπªï∑’Ë√—∫µ—«Õ¬à“ß

(c) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßÀâÕßªØ‘∫—µ‘°“√∑’Ë∑¥ Õ∫µ—«Õ¬à“ß

(d) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßºŸâ¬◊Ëπ§”√âÕß¢Õµ√«®«‘‡§√“–Àå

(e) ™◊ËÕ √“¬≈–‡Õ’¬¥ ·≈–‡≈¢√ÿàπ∑’Ëº≈‘µ¢Õßµ—«Õ¬à“ß (µ“¡§«“¡‡À¡“– ¡)

(f) ™◊ËÕ·≈–∑’ËÕ¬Ÿà¢ÕßºŸâº≈‘µÀ≈—° ·≈–ºŸâ·∫àß∫√√®ÿ ·≈–/À√◊ÕºŸâ®—¥®”Àπà“¬ (∂â“¡’)

(g) °“√Õâ“ßÕ‘ß∂÷ß¢âÕ°”Àπ¥¡“µ√∞“π∑’Ë„™â„π°“√∑¥ Õ∫µ—«Õ¬à“ß

(h) º≈¢Õß°“√∑¥ Õ∫∑ÿ°√“¬°“√ (§à“‡©≈’Ë¬·≈–§à“‡∫’Ë¬ß‡∫π¡“µ√∞“π) æ√âÕ¡‡°≥±å°”Àπ¥

(i) ¢âÕ √ÿª«à“º≈°“√∑¥ Õ∫µ—«Õ¬à“ßÕ¬Ÿà„π‡°≥±å¡“µ√∞“π°”Àπ¥À√◊Õ‰¡à

(j) «—π ‘ÈπÕ“¬ÿ À√◊Õ «—π∑’ËµâÕß∑¥ Õ∫„À¡à (∂â“¡’)

(k) «—π‡¥◊Õπªï∑’Ë∑”°“√∑¥ Õ∫‡ √Á® ‘Èπ ·≈–

(l) ≈“¬¡◊Õ™◊ËÕ¢ÕßÀ—«Àπâ“ÀâÕßªØ‘∫—µ‘°“√À√◊ÕºŸâ¡’Õ”π“®

À¡“¬‡Àµÿ : Guideline on Model certificate of analysis ª√—∫ª√ÿß‚¥¬ the WHO Expert Committee

on Specifications for Pharmaceutical Preparations „π°“√ª√–™ÿ¡§√—Èß∑’Ë 36 (3)

20. µ—«Õ¬à“ß∑’Ë‡°Á∫À≈—ß«‘‡§√“–Àå·≈â«‡ √Á®

20.1 §«√‡°Á∫µ—«Õ¬à“ß‰«â à«πÀπ÷Ëßµ“¡∑’Ë°ÆÀ¡“¬°”Àπ¥À√◊Õµ“¡∑’ËºŸâ¬◊Ëπ§”√âÕß¢Õµ√«®«‘‡§√“–ÀåµâÕß°“√

‚¥¬µ—«Õ¬à“ß∑’Ë‡°Á∫‰«â§«√¡’ª√‘¡“≥∑’Ë‡æ’¬ßæÕ∑’Ë®–∑”°“√«‘‡§√“–Àå´È”‰¥âÕ¬à“ßπâÕ¬ 2 §√—Èß ·≈–§«√‡°Á∫µ—«Õ¬à“ß„π

∫√√®ÿ¿—≥±å ÿ¥∑â“¬¢Õßº≈‘µ¿—≥±åπ—ÈπÊ



78

Part four. Safety

21. General rules

21.1 General and specific safety instructions reflecting identified risk, should be madeavailable to each staff member and supplemented regularly as appropriate (e.g. with writtenmaterial, poster displays, audiovisual material and occasional seminars).

21.2 General rules for safe working in accordance with national regulations and SOPsnormally include the following requirements:

(a) safety data sheets should be available to staff before testing is carried out;

(b) smoking, eating and drinking in the laboratory should be prohibited;

(c) staff should be familiar with the use of fire-fighting equipment, includingfire extinguishers, fire blankets and gas masks;

(d) staff should wear laboratory coats or other protective clothing, including eyeprotection;

(e) special care should be taken, as appropriate, in handling, for example, highlypotent, infectious or volatile substances;

(f) highly toxic and/or genotoxic samples should be handled in a specially designedfacility to avoid the risk of contamination;

(g) all containers of chemicals should be fully labelled and include prominentwarnings (e.g. çpoisoné , çflammableé , çradioactiveé) whenever appropriate;

(h) adequate insulation and spark-proofing should be provided for electrical wiringand equipment, including refrigerators;

(i) rules on safe handling of cylinders of compressed gases should be observedand staff should be familiar with the relevant colour identification codes;

(j) staff should be aware of the need to avoid working alone in the laboratory; and

(k) first-aid materials should be provided and staff instructed in first-aid techniques,emergency care and the use of antidotes.


79À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

à«π∑’Ë 4 §«“¡ª≈Õ¥¿—¬

21. À≈—°‡°≥±å∑—Ë«‰ª

21.1 §«√®—¥„Àâ¡’§”·π–π”·°àºŸâªØ‘∫—µ‘ß“π∑ÿ°§π „π¥â“π§«“¡ª≈Õ¥¿—¬∑—Ë«‰ª·≈–§«“¡ª≈Õ¥¿—¬‡©æ“–¥â“π

∑’Ë –∑âÕπ∂÷ß§«“¡‡ ’Ë¬ß∑’ËÕ“®®–∑”„Àâ‡°‘¥Õ—πµ√“¬¢÷Èπ ·≈–¡’°“√ª√—∫ª√ÿß‡æ‘Ë¡‡µ‘¡§”·π–π”¥—ß°≈à“«Õ¬à“ß ¡Ë”‡ ¡Õ

µ“¡§«“¡‡À¡“– ¡ (‡™àπ °“√®—¥∑”‡ªìπ‡Õ° “√ · ¥ß‚ª ‡µÕ√å ®—¥∑”‡ªìπ«’¥’∑—»πå À√◊Õ®—¥ —¡¡π“‡ªìπ§√—Èß§√“«)

21.2 À≈—°‡°≥±å∑—Ë«‰ª ”À√—∫°“√∑”ß“πÕ¬à“ßª≈Õ¥¿—¬µ“¡∑’Ë°ÆÀ¡“¬·≈–¡“µ√∞“π°“√ªØ‘∫—µ‘ß“π°”Àπ¥

´÷Ëßª√–°Õ∫¥â«¬‡π◊ÈÕÀ“ ¥—ßµàÕ‰ªπ’È:

(a) ºŸâªØ‘∫—µ‘ß“π∑ÿ°§π§«√√—∫∑√“∫‡Õ° “√¢âÕ¡Ÿ≈¥â“π§«“¡ª≈Õ¥¿—¬°àÕπ°“√ªØ‘∫—µ‘ß“π

(b) Àâ“¡ Ÿ∫∫ÿÀ√’Ë ·≈–√—∫ª√–∑“πÕ“À“√À√◊Õ¥◊Ë¡‡§√◊ËÕß¥◊Ë¡„πÀâÕßªØ‘∫—µ‘°“√

(c) ºŸâªØ‘∫—µ‘ß“π§«√¡’§«“¡ “¡“√∂„™âÕÿª°√≥å¥—∫‰ø √«¡∂÷ß‡§√◊ËÕß¥—∫‡æ≈‘ß ºâ“Àà¡°—π‰ø ·≈–

Àπâ“°“°ªÑÕß°—π°ä“´‰¥â

(d) ºŸâªØ‘∫—µ‘ß“π§«√ «¡‡‡§√◊ËÕß·∫∫ªØ‘∫—µ‘°“√À√◊Õ™ÿ¥ªÑÕß°—πÕ◊ËπÊ √«¡∂÷ßÕÿª°√≥åªÑÕß°—π¥«ßµ“

(e) §«√„™â§«“¡√–¡—¥√–«—ß‡ªìπæ‘‡»…µ“¡§«“¡‡À¡“– ¡„π°“√®—¥°“√°—∫ “√∑’Ë¡’Õ—πµ√“¬ Ÿß “√

∑’Ë∑”„Àâµ‘¥‡™◊ÈÕ À√◊Õ “√√–‡À¬

(f) °“√®—¥°“√‡°’Ë¬«°—∫µ—«Õ¬à“ß∑’Ë¡’§«“¡‡ªìπæ‘… Ÿß·≈–/À√◊Õ‡ªìπæ‘…µàÕæ—π∏ÿ°√√¡ §«√¥”‡π‘π°“√

¿“¬„µâÕÿª°√≥å∑’Ë‰¥â√—∫°“√ÕÕ°·∫∫‡ªìπæ‘‡»…‡æ◊ËÕÀ≈’°‡≈’Ë¬ß§«“¡‡ ’Ë¬ß®“°°“√ªπ‡ªóôÕπ

(g) ¿“™π–∫√√®ÿ “√‡§¡’∑ÿ°™π‘¥§«√µ‘¥©≈“°√–∫ÿ√“¬≈–‡Õ’¬¥§√∫∂â«π ·≈–¡’¢âÕ§«“¡·®âß‡µ◊Õπ

µ“¡§«“¡‡À¡“– ¡ ‡™àπ ‡ªìπæ‘… µ‘¥‰ø À√◊Õ·ºà√—ß ’

(h) §«√µ‘¥µ—Èß©π«π·≈–Õÿª°√≥åªÑÕß°—π‰ø™ÁÕµ ”À√—∫ “¬‰ø·≈–‡§√◊ËÕß„™â‰øøÑ“µà“ßÊ √«¡∂÷ß

µŸâ‡¬Áπ

(i) §«√¡’À≈—°‡°≥±å¥â“π§«“¡ª≈Õ¥¿—¬‡°’Ë¬«°—∫°“√„™âß“π∂—ß°ä“´ ·≈–ºŸâªØ‘∫—µ‘ß“π§«√∑√“∫∂÷ß

—≠≈—°…≥å ’µà“ßÊ ∑’Ë√–∫ÿ∑’Ë∂—ß

(j) ºŸâªØ‘∫—µ‘ß“π‰¡à§«√ªØ‘∫—µ‘ß“π„πÀâÕßªØ‘∫—µ‘°“√µ“¡≈”æ—ß ·≈–

(k) §«√®—¥„Àâ¡’Õÿª°√≥åª∞¡æ¬“∫“≈ ·≈–ºŸâªØ‘∫—µ‘ß“π§«√‰¥â√—∫°“√·π–π”‡∑§π‘§°“√ª∞¡æ¬“∫“≈

‡∫◊ÈÕßµâπ °“√¥Ÿ·≈°√≥’©ÿ°‡©‘π·≈–°“√„™â “√µâ“πæ‘…



80

21.3 Protective clothing should be available, including eye protection, masks andgloves. Safety showers should be installed. Rubber suction bulbs should be used on manualpipettes and siphons. Staff should be instructed in the safe handling of glassware, corrosivereagents and solvents and particularly in the use of safety containers or baskets to avoid spillagefrom containers. Warnings, precautions and instructions should be given for work with violent,uncontrollable or dangerous reactions when handling specific reagents (e.g. mixing water and acids,or acetone-chloroform and ammonia), flammable products, oxidizing or radioactive agents andespecially biologicals such as infectious agents. Peroxide-free solvents should be used. Staffshould be aware of methods for the safe disposal of unwanted corrosive or dangerous productsby neutralization or deactivation and of the need for safe and complete disposal of mercury andits salts.

21.4 Poisonous or hazardous products should be singled out and labeled appropriately,but it should not be taken for granted that all other chemicals and biologicals are safe.Unnecessary contact with reagents, especially solvents and their vapours, should be avoided.The use of known carcinogens and mutagens as reagents should be limited or totally excludedif required by national regulations. Replacement of toxic solvents and reagents by less toxicmaterials or reduction of their use should always be the aim, particularly when new techniquesare developed.


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21.3 §«√¡’Õÿª°√≥åªÑÕß°—π √«¡∂÷ßÕÿª°√≥åªÑÕß°—π¥«ßµ“ Àπâ“°“°·≈–∂ÿß¡◊Õ ¡’°“√µ‘¥µ—Èß safety

shower §«√„™â≈Ÿ°¬“ß ”À√—∫ manual pipette ·≈– siphon ºŸâªØ‘∫—µ‘ß“π§«√‰¥â√—∫°“√Õ∫√¡§«“¡ª≈Õ¥¿—¬

„π°“√„™â‡§√◊ËÕß·°â« “√∑’Ë¡’ƒ∑∏‘Ï°—¥°√àÕπ µ—«∑”≈–≈“¬ ·≈–‚¥¬‡©æ“–°“√„™â¿“™π–∫√√®ÿπ‘√¿—¬ ‡æ◊ËÕªÑÕß°—π

“√°√–‡¥ÁπÕÕ°®“°¿“™π–∫√√®ÿ §«√¡’§”‡µ◊Õπ ¢âÕ§«√√–«—ß·≈–«‘∏’°“√ªØ‘∫—µ‘ß“π ”À√—∫ß“π∑’ËÕ“®‡°‘¥

Õ—πµ√“¬®“°°“√‡°‘¥ªØ‘°‘√‘¬“∑’Ë√ÿπ·√ß ‰¡à “¡“√∂§«∫§ÿ¡‰¥âÀ√◊Õ‡¡◊ËÕ„™â “√‡§¡’‡©æ“– (‡™àπ °“√º ¡πÈ”°—∫°√¥

À√◊Õ Õ–´’‚µπ-§≈Õ‚√øÕ√å¡°—∫·Õ¡‚¡‡π’¬) “√µ‘¥‰ø “√ÕÕ° ‘‰¥´å “√°—¡¡—πµ√—ß ’ ‚¥¬‡©æ“– “√∑“ß™’«¿“æ

‡™àπ “√∑’Ë∑”„Àâµ‘¥‡™◊ÈÕ §«√„™âµ—«∑”≈–≈“¬∑’Ëª√“»®“°‡ªÕ√åÕÕ°‰´¥å ºŸâªØ‘∫—µ‘ß“π§«√§”π÷ß∂÷ß«‘∏’°“√∑’Ëª≈Õ¥¿—¬

„π°“√°”®—¥ “√∑’Ë¡’ƒ∑∏‘Ï°—¥°√àÕπ À√◊Õº≈‘µ¿—≥±å∑’Ë‡ªìπÕ—πµ√“¬ ‚¥¬°“√∑”„Àâ‡ªìπ°≈“ß À√◊Õ∑”„ÀâÀ¡¥ƒ∑∏‘Ï

√«¡∂÷ß°“√°”®—¥ “√ª√Õ∑·≈–‡°≈◊Õ¢Õß “√ª√Õ∑¥â«¬

21.4 º≈‘µ¿—≥±å∑’Ë‡ªìπæ‘…À√◊Õ¡’Õ—πµ√“¬§«√¡’°“√·¬°‡°Á∫·≈–µ‘¥©≈“°Õ¬à“ß‡À¡“– ¡ ·µà∑—Èßπ’È¡‘‰¥â

À¡“¬§«“¡«à“ “√‡§¡’À√◊Õ “√∑“ß™’«¿“æÕ◊ËπÊ ®–¡’§«“¡ª≈Õ¥¿—¬ §«√À≈’°‡≈’Ë¬ß°“√ —¡º— °—∫ “√∑”ªØ‘°‘√‘¬“

‚¥¬‡©æ“–µ—«∑”≈–≈“¬·≈–‰Õ√–‡À¬¢Õßµ—«∑”≈–≈“¬ Õ’°∑—Èß§«√®”°—¥°“√„™â “√°àÕ¡–‡√Áß ·≈– “√∑’Ë°àÕ„Àâ‡°‘¥

°“√‡ª≈’Ë¬π·ª≈ß∑“ßæ—π∏ÿ°√√¡À√◊ÕÀ≈’°‡≈’Ë¬ßÀ¬ÿ¥„™â„π°√≥’‡ªìπ¢âÕ∫—ß§—∫¥â“π°ÆÀ¡“¬¢Õßª√–‡∑» ‚¥¬¡ÿàß‡πâπ

„Àâ¡’°“√„™â “√∑’Ë¡’§«“¡‡ªìπæ‘…πâÕ¬°«à“∑¥·∑πÀ√◊Õ≈¥ª√‘¡“≥°“√„™â≈ß‚¥¬‡©æ“–‡¡◊ËÕ¡’°“√æ—≤π“‡∑§π‘§

„À¡àÊ ¢÷Èπ



82

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2. International Organization for Standardization. General requirements for the competence oftesting and calibration laboratories. ISO/IEC 17025:2005.

3. Model certificate of analysis. In: WHO Expert Committee on Specifications for PharmaceuticalPreparations. Thirty-sixth report. Geneva, World Health Organization, 2002, Annex 10(WHO Technical Report Series, No. 902).

4. International vocabulary of metrology-Basic and general concepts and associated terms.VIM 3rd ed., Joint Committee for Guides in Metrology (JCGM) 200:2008 (http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2008.pdf).

5. Guidance for industry-Investigating out-of-specification test results for pharmaceuticalproduction. US Food and Drug Administration, Center for Drug Evaluation and Research(CDER), October 2006 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf).

6. Guidelines for inspection of drug distribution channels. In: WHO Expert Committee onSpecifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World HealthOrganization, 1999, Annex 6 (WHO Technical Report Series, No. 885).

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9. International Organization for Standardization. Guidance for the use of repeatability,reproducibility and trueness estimates in measurement uncertainty estimation. 2004 (ISOGuide 21748).

10. International Organization for Standardization/International Electrotechnical Commission.Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement(GUM:1995) 2008 (ISO/IEC Guide 98-3).


83À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

11. Supplementary guidelines in good manufacturing practice: validation. Qualification ofsystems and equipment. In: WHO Expert Committee on Specifications for PharmaceuticalPreparations. Fortieth report. Geneva, World Health Organization, 2006, Annex 4,Appendix 6 (WHO Technical Report Series, No. 937).

12. Supplementary guidelines in good manufacturing practice: validation. Validation ofcomputerized systems. In: WHO Expert Committee on Specifications for PharmaceuticalPreparations. Fortieth report. Geneva, World Health Organization, 2006, Annex 4,Appendix 5 (WHO Technical Report Series, No. 937).

13. Good automated manufacturing practice (GAMP) Good Practice Guides: Validation of laboratorycomputerized systems. International Society for Pharmaceutical Engineering (ISPE), 2005.

14. Good automated manufacturing practice (GAMP) Good Practice Guides:Electronic dataarchiving. International Society for Pharmaceutical Engineering (ISPE), 2007.

15. Title 21 Code of Federal Regulations (21 CFR Part 11): Electronic records; electronicsignatures. US Food and Drug Administration. The current status of 21 CFR Part 11 Guidanceis located under Regulations and Guidance at: http://www.fda.gov/cder/gmp/index.htm-seebackground: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf

16. Computerised systems. In: The rules governing medicinal products in the European Union.Vol. 4. Good manufacturing practice (GMP) guidelines. Annex 11 (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/anx11en.pdf).

17. Official Medicines Control Laboratories Network of the Council of Europe, Quality AssuranceDocuments: PA/PH/OMCL (08) 69 3R-Validation of computerised systems-core document(http://www.edqm.eu/site/Validation_of_Computerised_Systems_Core_Documentpdf-en-8390-2.html) and its annexes:

- PA/PH/OMCL (08) 87 2R - Annex 1: Validation of computerized calculation systems: exampleof validation of in-house software (http://www.edqm.eu/site/NEW_Annex_1_Validation_of_computerised_calculationpdf-en-8391-2.html),

- PA/PH/OMCL (08) 88 R - Annex 2: Validation of Databases (DB), Laboratory InformationManagement Systems (LIMS) and Electronic Laboratory Notebooks (ELN) (http://www.edqm.eu/site/NEW_Annex_2_Validation_of_Databases_DB_Laboratory_pdf-en-8392-2.html),

- PA/PH/OMCL (08) 89 R - Annex 3: Validation of computers as part of test equipment(http://www.edqm.eu/site/NEW_Annex_3_Validation_of_computers_as_part_of_tespdf-en-8393-2.html).

18. Guidelines for good laboratory practice and guidelines for the testing of chemicals. Organisationfor Economic Co-operation and Development (OECD), Environment Directorate, Chemical Safety.(http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_1_1_1,00.html).



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19. The International Pharmacopoeia, Fourth Edition (including First Supplement).Vol. 2. Methodsof analysis. Geneva, World Health Organization, 2008 (http://www.who.int/phint).

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- PA/PH/OMCL (06) 86 DEF - Annex 2: Qualification of GC Equipment(http://www.edqm.eu/medias/fichiers/Annex_2_Qualification_of_GC_equipment.pdf),

- PA/PH/OMCL (07) 11 DEF CORR - Annex 3: Qualification of UV-visible spectrophotometers(http://www.edqm.eu/medias/fichiers/Annex_3_Qualification_of_UV_Visible_spectrophotometers.pdf),

- PA/PH/OMCL (07) 12 DEF CORR-Annex 4: Qualification of IR spectrophotometers(http://www.edqm.eu/medias/fichiers/Annex_4_Qualification_of_IR_spectrophotometers.pdf),

- PA/PH/OMCL (07) 108 3R-Annex 5: Qualification of automatic titrators (http://www.edqm.eu/medias/fichiers/NEW_Annex_5_Qualification_of_Automatic_Titrators.pdf).

21. US Pharmacopeia, 32nd ed. General chapters: <1058> Analytical instrument qualification.Rockville, MD, 2009.

22. WHO guidelines for sampling of pharmaceutical products and related materials. In: WHOExpert Committee on Specifications for Pharmaceutical Preparations. Thirty-ninth report.Geneva, World Health Organization, 2005, Annex 4 (WHO Technical Report Series, No. 929).

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25. Guid eline of the International Conference on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human Use (ICH) Q2(R1): Validation of analyticalprocedures: text and methodology (http://www.ich.org/LOB/media/MEDIA417.pdf).


85À≈—°ªØ‘∫—µ‘∑’Ë¥’ ”À√—∫

ÀâÕßªØ‘∫—µ‘°“√§«∫§ÿ¡§ÿ≥¿“æ‡¿ —™¿—≥±å

26. Official Medicines Control Laboratories Network of the Council of Europe, Quality AssuranceDocuments: PA/PH/OMCL (05) 47 DEF-Validation of analytical procedures (http://www.edqm.eu/medias/fichiers/Validation_of_Analytical_Procedures.pdf).

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- PA/PH/OMCL (07) 106 DEF-Uncertainty of measurement-Part 2: OMCL policy on theestimation and application of uncertainty in analytical measurement (http://www.edqm.eu/medias/fichiers/Uncertainty_of_Measurements_Part_II_Other_than_compliance_testing.pdf).

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86

Appendix

Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory

A list of equipment considered by the Committee to be adequate either for a first-stageor medium-sized pharmaceutical quality control laboratory is given in the table. In the caseof a medium-sized laboratory, specific sections are devoted to a microbiology unit andpharmacognosy/ phytochemistry unit. For a first-stage laboratory testing herbal medicines,the additional equipment recommended is specified in the table.

This list does not represent any requirements which should be fulfilled to complywith these guidelines. NMRAs or laboratories wishing to perform pharmaceutical analysesmay consider the following list in the establishment or upgrading of their testing facilities.For budgetary reasons it is necessary, besides the cost of equipment, to take into considerationthe cost of reference materials, reagents, solvents, glassware, other laboratory commoditiesand personnel. Experience has shown that for sustainability, a laboratory should allow a marginof 10-15% per year of the purchasing expenditure on equipment to cover the cost ofmaintenance.


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88


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