Simple Instruction To GMP
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Vinay PatelSimple Instruction To GMP
Uploaded by
Vinay PatelINTRODUCTION TO GMP
ENSURING QUALITY, SAFETY AND
COMPLIANCE IN MANUFACTURING
INTRODUCE YOURSELF
Name: Md. Mansur Rahman Bhuiyan
Pharmacy 00 Batch
Head of Department, Q&V, AJA Pharma, KSA
Ex. Senior Manager, QA, Incepta
Ex. Senior Executive, QA, Square
Professional Achievement:
Lean Six Sigma Black Belt,
ASQ Member,
ISO Lead Auditor 9001:2015
2005
2025
205022050
QA
GMP
QC
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)
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.
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
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
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
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
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
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
6. Production & process control
1. Writtenprocedures; 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
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.
8. Holding & distribution
1.Warehousing procedures
2.Distribution Procedures
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
10. Returned & salvaged drug products
1. Returned products
2. Salvaged products
11. Reports & records
1. General Requirements
2. Written Record
3. Component
4. Master Production
5. Laboratory Records
6. Distribution Records
7. Complaint Files