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Main Document - Chapters

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Annex 1 Manufacture Of Sterile Medicinal Products
Annex 2 Manufacture Of Biological Medicinal Products For Human Use
Annex 3 Manufacture Of Radiopharmaceuticals
Annex 4 Manufacture Of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products
Annex 5 Manufacture Of Immunological Veterinary Medicinal Products
Annex 6 Manufacture Of Medicinal Gases
Annex 7 Manufacture Of Herbal Medicinal Products
Annex 8 Sampling Of Starting And Packaging Materials
Annex 9 Manufacture Of Liquids, Creams And Ointments
Annex 10 Manufacture Of Pressurised Metered Dose Aerosol Preparations For Inhalation
Annex 11 Computerised Systems
Annex 11 (Updated) Computerised Systems - For review and comment
Annex 12 Use Of Ionising Radiation In The Manufacture Of Medicinal Products
Annex 13 Manufacture Of Investigational Medicinal Products
Annex 14 Manufacture Of Medicinal Products Derived From Human Blood Or Plasma
Annex 15 Qualification And Validation
Annex 15b Validation Master Plan Design Qualification, Installation And Operational Qualification Non-Sterile Process Validation Cleaning Validation
Annex 16 Certification By A Qualified Person And Batch Release
Annex 17 Parametric Release
Annex 18 Good Manufacturing Practice For Active Pharmaceutical Ingredients
Annex 19 Reference And Retention Samples
Annex 20 Quality Risk Management
GDP Guide Good Distribution Practice Guideline