GMP is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards approproiate to their intended use.
It is concerned with both production & quality control.
Product is considered adulterated if GMP is not followed
3. DEFINITION
GMP is a part of quality assurance which ensures that
products are consistently produced and controlled to the
quality standards approproiate to their intended use.
It is concerned with both production & quality control.
Product is considered adulterated if GMP is not followed
4. GMP INCLUDES:
1. Personnel
2. Building & Facilities
3. Equipment
4. Sanitation & Hygiene
5. Control of components, Drug product containers & closures
6. Production & Process controls
7. Packaging & Labeling Controls
8. Holding & Distribution
9. Laboratory Controls
10. Returned & Salvaged Drug Products
11. Reports & Records (Documentation)
5. 1. PERSONNEL
• Individual responsibility should be clearly
understood by the individual & recorded.
• Should be aware of GMP principles
• Manufacturer should have adequate no. of
personnel with necessary qualification & practical
experience.
7. RESPONSIBILITIES OF HEAD OF PRODUCTION:
• Products are produced & stored according to the appropriate
documentation.
• Approve instructions related to the production operations.
• Production records are evaluated & signed by an authorized
person.
• Check maintenance of his department, premises & equipment.
• Initial & continuing training of his department personnel is carried
out.
8. JOINT RESPONSIBILITIES OF HEAD OF PRODUCTION & QC
• Authorization of written procedures
• Monitoring & control on manufacturing environment
• Plant hygiene
• Process validation
• Training
• Approval & monitoring of suppliers of materials
• Monitoring storage conditions
• Retention of records
• Monitoring compliance with GMP requirements
• Inspection, investigation & taking samples
10. 2. BUILDING & FACILITIES
• Suitable size building
• Adequate space for orderly placement of equipment to prevent
mixups
• Operations should be performed in specifically defined areas to
prevent mixups
• Storage of released components, drug product containers, closures
& labeling
• Quarantine storage before release of drug products
• Storage of drug products after release
• Floors, walls & ceilings easily cleanable
11. 2. BUILDING & FACILITIES
• Temp & humidity control
• Air supply filtered through HEPA filters
• Heating, Ventilation & Air Conditioning (HVAC)
• Ventilation in all areas
• Proper disposal system for sewage, trash & other waste
• Adequate washing facilities
• Sanitation: from rodents, birds & insects
• Cleaning schedules, materials, equipment & methods
12. 3. EQUIPMENT
• Appropriate design
• Appropriate size
• Equipment should be constructed in such a way
that the surfaces of it should not be reacted with
the components
• Equipment cleaning & maintenance
13. 4. SANITATION & HYGIENE
• Personnel, premises, equipment, apparatus, production
materials, containers
• Potential sources of contamination should be eliminated
• Layout & design of plant should aim to minimize the risk,
avoid cross-contamination & permit effective cleaning
14. 5. CONTROL OF COMPONENTS, DRUG PRODUCTS,
CONTAINERS & CLOSURED
A. General Requirements:
• There must be written procedures describing receipt,
identification, storage, handling, sampling, testing & approval or
rejection of drug components, containers & closures
• Should be stored in a manner to prevent contamination
• Distinctive identification code for container of components
B. Receipt & storage of untested components
C. Testing & approval or rejection of components
15. 5. CONTROL OF COMPONENTS, DRUG PRODUCTS,
CONTAINERS & CLOSURED
D. Use of approved components should be rotated to
ensure that oldest approved stock is used first
E. Components must be retested/reevaluated after long
time
F. Rejected components should be identified & controlled
under quarantine area
G. Container & closures
16. 6. PRODUCTION & PROCESS CONTROL
1. Written procedures; deviations.
2. Charge-in of components.
3. Calculation of yield.
4. Equipment identification.
5. Sampling and testing of in-process materials and
drug products.
6. Time limitations on production.
7. Control of microbiological contamination.
8. Reprocessing
17. 7. PACKAGING & LABELLING CONTROL
• 1. Materials examination and usage criteria.
• 2. Labeling issuance.
• 3. Packaging and labeling operations.
• 4. Tamper-evident packaging requirements for over-
• the-counter (OTC) human drug products.
• 5. Drug product inspection.
• 6. Expiration dating.
18. 8. HOLDING & DISTRIBUTION
1.Warehousing procedures
2.Distribution Procedures
19. 9. LABORATORY CONTROLS
1. General Requirements
2. Testing & Release Requirements
3. Stability Testing
4. Special Testing Requirements
5. Reserved Samples
6. Animals used in testing components
20. 10. RETURNED & SALVAGED DRUG PRODUCTS
1. Returned products
2. Salvaged products
21. 11. REPORTS & RECORDS
1. General Requirements
2. Written Record
3. Component
4. Master Production
5. Laboratory Records
6. Distribution Records
7. Complaint Files
