WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
Annex 2
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TABLE OF CONTENTS
QUALITY MANAGEMENT IN THE MEDICINES INDUSTRY: PHILOSOPHY AND ESSENTIAL ELEMENTS
1. PHARMACEUTICAL QUALITY SYSTEM
2. GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS
4. QUALIFICATION AND VALIDATION
7. CONTRACT PRODUCTION, ANALYSIS AND OTHER ACTIVITIES
8. SELF-INSPECTION, QUALITY AUDITS AND SUPPLIERS’ AUDITS AND APPROVAL
Suppliers’ Audits and Approval
Intermediate And Bulk Products
Rejected, Recovered, Reprocessed And Reworked Materials
16. GOOD PRACTICES IN PRODUCTION
Prevention Of Cross-Contamination And Bacterial Contamination During Production
17. GOOD PRACTICES IN QUALITY CONTROL
Control Of Starting Materials And Intermediate, Bulk And Finished Products
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles,
(Annex 2, WHO Technical Report Series 986, 2014)
