Requirements for active substances used as starting materials in veterinary medicinal products.EU GMP guide part IV: GMP requirements for advanced therapy medicinal products (ATMP): Guidelines on GMP specific to ATMPs.23 (3) of regulation 2021/1248 requirement relating the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock GMP certificates, non-compliance statements and manufacturing authorisations.EU GMP guide annexes: Supplementary requirements: Annex 19: Reference and retention samples.

Question and answer on residency of the qualified person(QP) - NEW July 2023.

Questions and answers on remote batch certification / confirmation by the qualified person (QP) - NEW July 2023.

EU GMP guide annexes: Supplementary requirements: Annex 16.

EU GMP guide annexes: Supplementary requirements: Annex 13.

EU GMP guide annexes: Supplementary requirements: Annex 12.

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 7: Outsourced activities.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.

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