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WHO good manufacturing practices for …

77 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and essential elements 851. pharmaceutical quality system 85 Quality risk management 88 Product quality review 882. good manufacturing practices for pharmaceutical products 903. Sanitation and hygiene 914. Qualification and validation 915. Complaints 926. Product recalls 937. Contract production, analysis and other activities 94 General 94 The contract giver 94 The contract acceptor 95 The contract 968. Self-inspection, quality audits and suppliers audits and approval 97 Items for self-inspection 97 Self-inspection team 98 Frequency of self-inspection 98 Self-inspection report 98 Follow-up action 98 Quality audit 98 Suppliers audits and approval 981 The current document is a revision of WHO good manufacturing practices for pharmaceutical products: main princi

77 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and

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