GOOD MANUFACTURING PRACTICE (GMP) IN PHARMASUITICAL INDUSTRY

1. Bijeshmon PP
Manager
Quality Control Division
Sitaram Ayurveda Private Limited

2. • It is an international set of guidelines and regulations,
• For the manufacture of products such as food, cosmetics,
pharmaceutical goods etc.
• According to quality standards,
• Helps to ensure the products manufactured will have the
required quality.
• It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated through
testing of final product.
What is GMP…………………?
It is a matter of building in quality rather
than Testing quality.

3.  Unexpected contamination of the product, causing damage to health,
or even death (PURITY).
 Incorrect labels on packets, which could mean that patients get wrong
medicine (SAFETY).
 Insufficient or too much active ingredient resulting ineffective
treatment or adverse effect (EFFICACY).

4. Helps for People, equipment and organization
• Peoples become trained
• Uses of standard equipment
• Organization Standard and Income
• Helps to boost Export activities

5. Events which lead to Birth of GMP !
• In 1202, King John of England proclaimed the first English food law
• The Biological Control Act (1902), first introduced in the USA – due to
the death of 12 children.
• Sulfanilamide tragedy - cause the death of 107 children.
• Sulfathiazole tablets contamination – causes the death of 300 peoples

6. Events which lead to Birth of GMP !
GMPs were first established in June 1963 , The concept was born in
U.S.A
The Govt of India amended the drugs & cosmetics rules on 24th June
1988 and prescribed GMPs under Schedule M
Schedule M has 2 parts- part 1 and part 2
GMP guidelines come under part 1

7. • Raw materials used in the manufacture of drugs are
authentic, of prescribed quality and are free from
contamination.
• The manufacturing process is as has been prescribed to
maintain the standards.
• Adequate quality control measures are adopted.
• The manufactured drug which is released for sale is of
acceptable quality.
GMP ensure that…………..

8. Each licensee shall evolve methodology and
procedures
- Which should be documented as a manual
- and kept for reference and inspection.
To achieve these objectives

9. • Receiving and storing Raw material & Packing Materials
• Rejected goods/drugs store
• Manufacturing process areas
• Quality control section
• Finished goods store
• Office
THE BASIC REQUIREMENTS

10. • Free from open sewage
• Free from open Drainages
• Public lavatory or any factory which produces disagreeable or
obnoxious odour or fumes or excessive soot, dust or smoke.
LOCATION & SURROUNDINGS

12. Building
• Machines and equipment should be placed in proper manner to avoid
contamination
• Sanitary and electrical fittings should be proper and safe.
• Floor, walls and sealing should be smooth and free from cracks and
permit easy cleaning and disinfection.
• Fire and safety equipment should be placed
• Separate drying space should be required.

13. Water treatment system can also be adopted for
the purification of water

18. • Each category of RM should be store
separately
• Metallic
• Herbal
• Animal
• Oils
• Extracts
• Proper Labelling should be placed
• Product Name
• Supplier
• Quantity
• Date of received
• Approved Date
Status of Raw material should be place
UNDER TESTING, REJECTED , APPROVED
• Rejected RM should be kept in the rejected area
• FIFO System should be follow

19. PACKING MATERIAL STORE
FINISHED GOODS STORE
• All packing materials stored in separately such as Bottles, Jars, Labels etc.
• Capsules shells and aluminium foils should be kept in proper conditions.
• All finished goods should be stored in the Finished goods store after the
final approval from QA department
• Separate area should be allocated for each products.
• Only approved finished goods should be despatched
• Also maintain the distribution records.
FIFO system should be maintained

22. • Suitable equipment either manually operated, Semi
automatic or fully operated shall be made available
• Adequate space should be provided between machines
• Machines will be properly installed maintained with proper
cleaning and preventive maintenance.
• SOPs should be made available for all machines.
MACHINERY AND EQUIPMENT

23. BATCH MANUFACTURING RECORD (BMR)
RECORD OF MARKET COMPLAINTS

24. • Own QC lab or External Govt. Approved QC Lab.
• Testing as per AYUSH Standards and also as per own
standards or other sources.
• Raw materials and Packing materials and Finished products
should be tested by Quality Control Department.
QUALITY CONTROL

25. • QC Requirements
• Minimum 150 Sq. feet
• Reference book and reference standard should be maintained
• BMR should be maintained
• Finished product control sample should be maintained
• Specification should be maintained for all items
• Microbial parameters should be monitored
• Minimum persons of Ayurveda/Unani/Siddha qualification, each
from Botany/chemistry and pharmacy.
• Maintain all records of all internal and external testing
QUALITY CONTROL

26. Quality can never be attained accidently or by chance or by luck.
Quality is always the result of intelligent thinking and continuous
efforts.