H WHO Guidelines H WHO Guidelines
as of 2019 - 05 - 07
H.2 WHO good manufacturing practices for active pharmaceutical ingredients (Technical Report Series, No. 957 (2010), Annex 2)
1. Introduction
1.1 Objective
1.2 Regulatory applicability
1.3 Scope
2. Quality management
2.1 Principles
2.2 Responsibilities of the quality unit(s)
2.3 Responsibility for production activities
2.4 Internal audits (self-inspection)
2.5 Product quality review
3. Personnel
3.1 Personnel qualifications
3.2 Personnel hygiene
3.3 Consultants
4. Buildings and facilities
4.1 Design and construction
4.2 Utilities
4.3 Water
4.4 Containment
4.5 Lighting
4.6 Sewage and refuse
4.7 Sanitation and maintenance
5. Process equipment
5.1 Design and construction
5.2 Equipment maintenance and cleaning
5.3 Calibration
5.4 Computerized systems
6. Documentation and records
6.1 Documentation system and specifications
6.2 Equipment cleaning and use record
6.3 Records of raw materials, intermediates, API labelling and packaging materials
6.4 Master production instructions (master production and control records)
6.5 Batch production records (batch production and control records)
6.6 Laboratory control records
6.7 Batch production record review
7. Materials management
7.1 General controls
7.2 Receipt and quarantine
7.3 Sampling and testing of incoming production materials
7.4 Storage
7.5 Re-evaluation
8. Production and in-process controls
8.1 Production operations
8.2 Time limits
8.3 In-process sampling and controls
8.4 Blending batches of intermediates or APIs
8.5 Contamination control
9. Packaging and identification labelling of APIs and intermediates
9.1 General
9.2 Packaging materials
9.3 Label issuance and control
9.4 Packaging and labelling operations
10. Storage and distribution
10.1 Warehousing procedures
10.2 Distribution procedures
11. Laboratory controls
11.1 General controls
11.2 Testing of intermediates and APIs
11.3 Validation of analytical procedures
11.4 Certificates of analysis
11.5 Stability monitoring of APIs
11.6 Expiry and retest dating
11.7 Reserve/retention samples
12. Validation
12.1 Validation policy
12.2 Validation documentation
12.3 Qualification
12.4 Approaches to process validation
12.5 Process validation programme
12.6 Periodic review of validated systems
12.7 Cleaning validation
12.8 Validation of analytical methods
13. Change control
14. Rejection and reuse of materials
14.1 Rejection
14.2 Reprocessing
14.3 Reworking
14.4 Recovery of materials and solvents
14.5 Returns
15. Complaints and recalls
16. Contract manufacturers (including laboratories)
17. Agents, brokers, traders, distributors, repackers and relabellers
17.1 Applicability
17.2 Traceability of distributed APIs and intermediates
17.3 Quality management
17.4 Repackaging, relabelling and holding of APIs and intermediates
17.5 Stability
17.6 Transfer of information
17.7 Handling of complaints and recalls
17.8 Handling of returns
18. Specific guidance for APIs manufactured by cell culture/fermentation
18.1 General
18.2 Cell bank maintenance and record keeping
18.3 Cell culture/fermentation
18.4 Harvesting, isolation and purification
18.5 Viral removal/inactivation steps
19. APIs for use in clinical trials
19.1 General
19.2 Quality
19.3 Equipment and facilities
19.4 Control of raw materials
19.5 Production
19.6 Validation
19.7 Changes
19.8 Laboratory controls
19.9 Documentation
20. Glossary
References
Appendix 1
List of references for related WHO guidelines
Distribution
Production
Quality control
Related regulatory standards
Appendix 2
General notes: additional clarifications and explanations
API starting material
References
Username
Password
enlarge font size by using the short cut 'ctrl' and '+' (from IE 7, Firefox)