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Concept of rasashala w.s.r to gmp guidelines
1. By
Dr. K.Ganesh Naik
Final Year P. G.
Scholar.
Guide & Prof.
Dr. Surekha Medikeri M.D.(Ayu)
Prof. & H.O.D
Dr. M.S.Doddamani M.D.(Ayu)
Dept of PG studies in Rasashastra. T.G.A.M.C. Bellary.
Under the Guidance of
2. 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.
3. 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.
4. DIFFERENT GOOD PRACTICES
Good manufacturing practice(GMP)
Good laboratory practice(GLP)
Good distribution practice(GDP)
Good clinical practice(GCP)
Good regulatory practice(GRP)
5. The Regulation
Drugs and Cosmetics Act 1940
(Section 33-N)
Drugs and Cosmetics Rules 1945
Drugs and Cosmetics (Amendment) Rules 1999
Schedule T
6. 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.
7. 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.
8. 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.
12. 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.
13. 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’
14. 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.
15. 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.
16. LIST OF EQUIPMENTS
Khalwa, 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
17. SPACE REQUIREMENT FOR DTL
1) State drug analyst & admn.office -200x2=400 sq.ft
2) Drug sample store -200 sq.ft
3) Chemistry labs – 600x2=1200 sq.ft
4) Pharmacognocy / botany labs -600x2=1200 sq.ft
5) Instrumentation room -500sq.ft
6) Ayurvedic section -500sq.ft
7) Store / miscellaneous -500 sq.ft
hence TOTAL SPACE REQUIREMENT =4500 sq.ft
18. QUALITY CONTROL
Lab
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.
20. Health, Clothing, Sanitation and
Hygiene of Workers
Workers to be free from contagious diseases
Uniform
◦ 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
21. 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.
22. 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.
