CONCEPT OF RASASHALA W.S.R To GMP GUIDELINES

By Dr. K.Ganesh Naik Final Year P. G. Scholar.

Guide & Prof.Dr. Surekha Medikeri M.D.(Ayu)

Prof. & H.O.DDr. M.S.Doddamani M.D.(Ayu)

Dept of PG studies in Rasashastra. T.G.A.M.C. Bellary.

Under the Guidance of

INTRODUCTION

The concept of GMP is well known to every pharmaceutical company in the world.

Many countries express GMP in regulations, Codes and guidelines.

In this era of worldwide herbal & herbo-mineral drug revolution, there is a need to implement cGMP

To meet the worldwide demand for herbo-mineral products, it is essential to maintain GMP.

Definition of Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization (MA) or product specification.

GMP is concerned with both production and quality control.

What is cGMP?The “c” stands for “current”, reminding manufacturers that

they must employ technologies and systems which are up-to-date in order to comply with the regulations.

DIFFERENT GOOD PRACTICES

Good manufacturing practice(GMP)

Good laboratory practice(GLP)

Good distribution practice(GDP)

Good clinical practice(GCP)

Good regulatory practice(GRP)

The Regulation

Drugs and Cosmetics Act 1940 (Section 33-N)

Drugs and Cosmetics Rules 1945

Drugs and Cosmetics (Amendment) Rules 1999

Schedule T

SCHEDULE T

Raw materials used in manufacturing of drugs are authentic, of prescribed quality and free from contamination.

The manufacturing process is as has been prescribed and maintains standards of purity.

Adequate quality control measures are taken and The manufactured drug which is released for sale is of

acceptable quality.

To achieve the objectives listed above each licensee shall evolve methodology and procedures for manufacture of drugs which should be documented as a manual and kept for reference and inspection.

WHAT IS THE NEED OF GMP?

To assure the public that Ayurvedic drugs are safe.

To ensure that raw materials used in the manufacture of drugs

are authentic, of prescribed quality, and are free from

contaminatation.

The manufacturing process has been prescribed to maintain

standards.

Adequate quality control measures are adopted.

The manufactured drug released for sale is of acceptable quality.

IMPORTANT PART OF GMP

An extremely important part of GMP is Documentation of every aspect of process, activities, and

operations involved with the drugs and medical device manufacture. GMP takes holistic approach of regulating the manufacturing and

laboratory testing environment itself.

GMP mandates: All manufacturing and testing equipments have been qualified as

suitable for use. All operational methodologies and procedures such as

manufacturing, cleaning and analytical testing utilized in the drug manufacturing process have been validated.

RASASHALA

PHARMACY

Raw drugs &

equipments Equipments

for parada shodhana /marana

Lord Shiva

Furnaces etc for boiling,

drying, etcGrinding, pounding

Tablet making machine

Cutting & chopping

pulvarizers

Washing and

cleaning

Hot air ovenDisintegration drying

NN.EN.W

W

S.W SS.E

E

PHARMACY

MANUFACTURING

QUALITY CONTROL

QUALITY ASSURENC

E

QUALIFIED & TRAINED PERSONNELBotany / Pharmacognocy lab

1. Scientific officer ( M.sc / M.pharma /Ph.d)2. Analyst / lab technician (B.sc)

Chemistry section 3. Scientific officer ( M.sc / M.pharma /Ph.d)4. Analyst / lab technician (B.sc)

ISM & H Section5. Scientific officer ; M.D (Rasashastra / Dravyaguna)6. Lab attendant

SPACE REQUIREMENT FOR PHARMACY

A covered area that is at least 1400 square feet and should have adequate space for,

1) Receiving and storing raw materials.2) Manufacturing process area.3) Quality control section.4) Finished goods storage.5) Office.6) Rejected goods storage.

RAW MATERIALS FOR MANUFACTURING

Separate and adequate facilities for ◦ Raw materials of metallic origin◦ Raw materials of mineral origin◦ Raw materials from animal source◦ Fresh herbs◦ Dry herbs or plant parts◦ Excipients etc.◦ Volatile oils, perfumes and flavors◦ Plant extracts, exudates and resins

Labeling: ‘UNDER TEST’ or ‘APPROVED’ or ‘REJECTED’

GENERAL REQUIREMENT IN PHARMACY

a) Drugs can be produced under hygienic conditions.b) Facilities are compatible with other manufacturing

operations that may be carried out the same or adjacent premises.

c) There is adequate working space-to prevent the possibility of cross contamination.

d) The facility is designed, constructed, and maintained to prevent entry of insects and rodents.

e) Adequate water supply.f) Suitable drainage system.g) Proper fire and safety measures.

GMP SPECIFICATION FOR OPERATIONAL PROCEDURES & END PRODUCT

All manufacturing processes are clearly defined.Systemically reviewed in light of experience.Shown to be capable of consistently manufacturing. Instruction and procedures are written in clear & common

language.The quality and quantity of the product are as expected.Significant deviations are fully recorded and investigated.Complaints about marketed products are examined.The cause of quality of defects are investigated. Appropriate measures are taken regarding defective product

and to prevent recurrence of defective products.

LIST OF EQUIPMENTSKhalwa, bhatti, generator, ball-mill service,

Grinder, disintegration, pulveriser, powder mixer, mass mixer,

granulator drier,

De humidifier, hygrometer, tube filling machine, ointment

mixer, bottle washing machine, distillation plant,

Maceration tank, hot air oven, autoclave, tablet making

machine,electrical muffle furnace, wet grinder etc

SPACE REQUIREMENT FOR DTL

1) State drug analyst & admn.office -200x2=400 sq.ft2) Drug sample store -200 sq.ft3) Chemistry labs – 600x2=1200 sq.ft4) Pharmacognocy / botany labs -600x2=1200 sq.ft5) Instrumentation room -500sq.ft6) Ayurvedic section -500sq.ft7) Store / miscellaneous -500 sq.ft hence TOTAL SPACE REQUIREMENT =4500 sq.ft

QUALITY CONTROLLab

Personnel: To be headed by an independent person.

Duties:

◦ To prepare specifications and testing methods for raw materials and

finished products.

◦ To sample, test, approve or reject RMs, PMs, semi-finished product

and finished products.

◦ To supervise and monitor the adequacy of storage conditions.

◦ Maintenance of the records of each process where testing of

finished product is not possible.

PACKEGING MATRIAL

StorageTestingCleaningControls on printed materials to avoid wrong

labeling

Health, Clothing, Sanitation and Hygiene of Workers Workers to be free from contagious diseasesUniform

◦ Suitable for climate and nature of work including coverings for hands, feet and head wherever required

Facilities for personal cleanliness◦ Clean towels, soap, scrubbing brushes, lavatories, change

rooms & place for keeping personal belongings.Medical Services

◦ First aid◦ Medical Examination: At the time of employment and at

least once in a year

PROBLEMS ENCOUNTERED WITH GMP

All these raw materials have been used in formulations since ancient times based on traditional knowledge.

Adulteration in case of metals, minerals & animal products.

The only specification on quality is that they must satisfy the quality control specification as laid down in official books i.e. classics in Ayurveda.

CONCLUSION To meet the worldwide demand for herbo-mineral drugs, it

is essential to maintain GMP . Implementing GMP for herbo-mineral drugs, as per the

recent amendment of the Drugs and Cosmetic Act of the Government of India with a buffer period of two years, is a great challenge for Ayurvedic drugs.

Recently Govt. of India has notified GMP for ISM drugs. This is also aimed to ensure production of good quality medicines for the consumer in the domestic and international market.

It is necessary to maintain the consumer's interest in ensuring quality and standard and to meet the requirements of various importing countries for Ayurvedic drugs.