AUDIT NUMBER ON PAPER LICENSE REGISTRATION
Active substance registration (New July 2018).
GMP certificates, non-compliance statements and manufacturing authorisations.EU GMP guide annexes: Supplementary requirements: Annex 19: Reference and retention samples (Updated).EU GMP guide annexes: Supplementary requirements: Annex 16 (Updated May 2018).EU GMP guide annexes: Supplementary requirements: Annex 13.EU GMP guide annexes: Supplementary requirements: Annex 11: Computerised systems.EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Use of near-infrared (NIR) technology for container-wise identity testing.EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol.EU GMP guide annexes: Supplementary requirements: Annex 6: Manufacture of medicinal gases.EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products.EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances in investigational medicinal products (IMPs).EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances.EU GMP guide part I: Basic requirements for medicinal products: Chapter 8: Complaints, Quality Defects and Product Recalls.EU GMP guide part I: Basic requirements for medicinal products: Chapter 5: Production.EU GMP guide part I: Basic requirements for medicinal products: Chapter 3: Shared manufacturing facilities.EU GMP guide part I: Basic requirements for medicinal products: Chapter 3: Equipment.EU GMP guide part I: Basic requirements for medicinal products: Chapter 1: Pharmaceutical quality system (New July 2018).
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