114-Dec-16

2

RECENT AMENDMENTS IN GMP

Guided by:Dr. Vinay R KadibagilProfessor

Presented By:Dr.Shobitha Madhur

3rd Year PG Scholar

14-Dec-16

Dept of Rasashastra &Bhaishajya KalpanaSDM College of Ayurveda

Hassan

3

Introduction GMP - set of legal guidelines that have

been regulated by WHO since 1975. A production testing practice that helps

to ensure a quality product.

AIM :Safe and effective Pharmaceutical

products

14-Dec-16

4

GMP GuidelinesLocation and Surroundings

BuildingsWater system

Disposal of wasteWare house areaProduction areaAncillary area

Laboratory ControlsPersonnel

Equipments RecordsLabeling

SOP 14-Dec-16

5

Location, Building Away from open sewage, drain, public, dust, smoke, disagreeable odour Free from insects/rodents. Adequate light and ventilation Floor and wall should not be moist It should be according to provision of

factory act

14-Dec-16

6

Water supply and Disposal of waste

Treated water sysytem* - for all purpose

Potable water Store in tank – periodic cleaning * Provision for waste disposal – according

to pollution control board

14-Dec-16

7

Bio medical waste – Bio medical waste Management and handling rule 1996*

Central and state legislation – safe storage and disposal of waste material*

WAREHOUSE AREA:*1) Separate sampling area and finished

product area etc2) Raw material specification - ‘UNDER

TEST’ or ‘APPROVED’ or ‘REJECTED’.

14-Dec-16

8

Raw materials Good quality - selected Protected from microbiological

contamination Proper environmental condition should be

maintained It should be stored under different

categories The licensee shall keep inventory of all raw

materials and maintain records as per schedule T-A*

14-Dec-16

9

PRODUCTION AREA* Designed to allow the production

preferably in uni-flow and with logical sequence of operations

Pipe-work, electrical fittings, ventilation openings and similar service lines shall be designed, fixed and constructed to avoid [accumulation of dust]

14-Dec-16

10

ANCILLARY AREA* Rest and refreshment rooms shall be

separate from other areas Facilities for changing, storing clothes

and for washing and toilet purposes shall be easily accessible

Tools and spare parts for use in sterile areas shall be disinfected

14-Dec-16

11

QC AREA*

Independent of the production areas Separate areas shall be provided each

for pharmacognostical, chemical, microbiological analysis

The microbiology section shall have arrangements such as airlocks and laminar air flow work station, wherever considered necessary.

14-Dec-16

12

Quality control section will have a minimum of – (i) (a) Expert in Ayurveda or Sidha or Unani - a degree qualification recognized under Schedule II of IMCC Act 1970; (b) Chemist - Master Degree in Science or Pharmacy or Pharmacy (Ayurveda) - recognized University(c) Botanist (Pharmacognosist) - Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) - recognized University (d) Microbiologist - master degree in microbiology awarded by a recognized university.

14-Dec-16

13

PERSONNEL* The head of the QC Laboratory shall be

independent of the manufacturing unit

Qualified and experienced

Written duties of technical and Quality Control personnel shall be laid and followed strictly

14-Dec-16

14

Health, Clothing, Sanitation of Workers

Proper uniform shall be given Adequate facilities for personal

cleanliness Provide facilities for keep there personal

things Prior to appointment – personnel shall

undergo medical examination*

14-Dec-16

15

Continued* All persons, prior to and during

employment - trained in practices which ensure personal hygiene

No person showing, at any time, apparent illness or open lesions shall be allowed to handle materials – until proven safe

All personnel shall wear clean body coverings appropriate to their duties

14-Dec-16

16

MANUFACTURING OPERATIONS AND CONTROLS *

vessels and containers shall be conspicuously labeled with the name of the product, batch no., batch size and stage of manufacture

Precautions against mix-up and cross-contamination

14-Dec-16

17

SANITATION IN THE MANUFACTURING PREMISES *

Cleaned and maintained in an orderly manner

A validated cleaning procedure shall be maintained.

14-Dec-16

18

Equipment

Located, designed to suit the operations to be carried out*

Defective equipment shall be removed from production and Quality Control*

Suitable equipment - manually operated/ semi-automatic or fully automatic machinery made available

14-Dec-16

19

DOCUMENTATION AND RECORDS*

Documents shall be approved, signed and dated by appropriate and authorized persons

Documents shall specify the title, nature and purpose

14-Dec-16

20

LABELS AND OTHER PRINTED MATERIALS *

All containers and equipments shall bear appropriate labels. Different colour coded labels shall be used to indicate the status of a product (for example: under test, approved, passed, rejected)

14-Dec-16

21

QUALITY ASSURANCES*

ASU products are not released for sale or supplied before authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production

14-Dec-16

22

SELF INSPECTION AND QUALITY AUDIT*

To evaluate the manufacturer’s compliance with GMP concept of self-inspection shall be followed

Designed to detect shortcomings in the implementation of GMP and to recommend the necessary corrective actions

14-Dec-16

23

RECORDS * Packaging records Batch packaging records* Batch Processing records*OTHERS* SOPs Sampling, testing, Records of analysis Batch numbering Reprocessing and Recoveries

14-Dec-16

24

Distribution records Record date,manpower,machines,and

equipments should be maintained. Record of sale and distribution of each

batch of medicine shall be maintained.

14-Dec-16

25

OTHER SPECIICATION* Validation and process validation Product recall Complaints and ADR Site master files – general information

about the firm and other information in summary form

14-Dec-16

26

Batch manufacturing records

Maintain batch manufacturing record of all types of product

List of raw materials, quantities and various tests with record should be maintained

Record of manufactured drug to finish product

Only after verified and accepted quality it is cleared for sale

14-Dec-16

27

Packaging materials Finished goods stores

Packaging materials such as bottles ,jars, capsules shall be stored properly

All cleaned and dried before packing the product

Finished goods shall be checked in quality control lab and referred for packing/labeling.

Dispatched as per market needs14-Dec-16

28

LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PERMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC SYSTEM OF MEDICINES (15)

14-Dec-16

29

S.No Category of  Medicine

Minimum  manufacturing space required

Machinery/  equipment recommend

1 Anjana/Pisti 100 Sq.  feet Khalva/mechnised/motorised,khalva, End runner/ Ball-Mill Sieves/Shifter

2 Churna/Nasya  Kwath Churna

200 Sq.feet Grinder/  Disintegrator/ Lepa Pulverisar/ Powder mixer/  sieves.

3 Pills/Vatti/Gutika Tablets

100  Sq.feet Ball  Mill, Mass mixer powder mixer pill/vati cuttingmachine,stainless  steel trays/ Containers for Storage. Driers/Mechanised chattee(for mixing  guggul) where required.

4 Kupi  pakva/ Ksara/Parpati/ Lavana Bhasma Satva/

150  Sq.feet Stainless Steel Vessels/ Flask, Multani Matti/Plaster of  Paris/Copper Rod,Earthen container, Muffle furnace(Electrically  Operated) End/Edge Runner, Exhaust Fan, Wooden Spatula.

14-Dec-16

30

C. LIST OF EQUIPMENT RECOMMENDED FOR IN HOUSE QUALITY CONTROL SECTION* (30)

14-Dec-16

3114-Dec-16

32

D. Specific Requirements for Manufacturing of Rasaushadhies or Rasamaraunthukul and Kushtajat (herb-mineral-metallic compound) of Ayurveda, Siddha and Unani Medicines*

14-Dec-16

33

GMP certificate for Rasaushadhi - State Licensing Authority only after thorough inspection by an expert team including Rasashastra experts nominated by the Department of AYUSH

Manufacturing Process Areas a)Bhatti or Heating Devise Section b) Grinding, Drying and Processing Sectionc) Fuel usedd) Manufacturing area - toxic fumes like SO2, arsenic and mercury

vapour etc - suitable ventilation and air exhaust flow mechanism

14-Dec-16

34

Records shall be maintained specially for temperatures attained during the entire process of Bhasmikaran

In Process Quality Control Shodhan RegisterBhavana and Putta Register Grinding RecordsPacking details Product Quality Control Bhasma pareeksha

Product recallsLiterature inserted inside the products package -

indicating the name, address of the manufacturing unit/ email / telephone number for reporting of any ADR

14-Dec-16

35

Area Specification/requirement for an applicant companies only to have GMP of Rasaushadhies or Rasamaraunthukul and Kushtajat (Herbo-mineral-metallic compounds) of Ayurveda, Siddha and Unani Medicines *(Total 1500 sqft)

14-Dec-16

3614-Dec-16

37

RELATED ARTICLES A REVIEW OF RASASHALA IN

ACCORDANCE WITH GMPDr. Sourav Pal et al, wjpmr, 2016,2(5),

76-82

Good Manufacturing Practices: A pathway towards quality ASU medicines

Kaushal Arushi, Int J Ayu Pharm Chem Vol. 2 Issue 1, 2015

14-Dec-16

38

DISCUSSION AND CONCLUSION

GMP – Globalisation of Ayurvedic formulation

Amended due to low standard Ayurvedic product

Importance has been given for record keeping as well as Rasaushadi preparation

Emphasis is laid on Water system, disposal of waste

14-Dec-16

39

THANK YOU

14-Dec-16