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The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Community procedures, states that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers.

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 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.