H WHO Guidelines H WHO Guidelines
as of 2019 - 05 - 07
H.1 WHO good manufacturing practices for pharmaceutical products: main principles (Technical Reports Series No. 986 (2014), Annex 2)
General considerations
Quality management in the medicines industry: philosophy and essential elements
1. Pharmaceutical quality system
Quality risk management
Product quality review
2. Good manufacturing practices for pharmaceutical products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production, analysis and other activities
The contract giver
The contract acceptor
The contract
8. Self-inspection, quality audits and suppliers’ audits and approval
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Follow-up action
Quality audit
Suppliers’ audits and approval
9. Personnel
Key personnel
10. Training
11. Personal hygiene
12. Premises
Ancillary areas
Storage areas
Weighing areas
Production areas
Quality control areas
13. Equipment
14. Materials
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected, recovered, reprocessed and reworked materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
15. Documentation
Documents required
Specifications and testing procedures
Specifications for starting and packaging materials
Specifications for intermediate and bulk products
Specifications for finished products
Master formulae
Packaging instructions
Batch processing records
Batch packaging records
Standard operating procedures and records
16. Good practices in production
Prevention of cross-contamination and bacterial contamination during production
Processing operations
Packaging operations
17. Good practices in quality control
Control of starting materials and intermediate, bulk and finished products
Test requirements
Starting and packaging materials
In-process control
Finished products
Batch record review
Stability studies
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