Guidance on good manufacturing practice and good distribution practice: Questions and answers

Table of contents

This content applies to human and veterinary medicines.

The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.

The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission. The working group prepares these Q&As as the need arises.

EMA may remove individual Q&As when the European Commission updates relevant guidelines.

Code

  • H: applicable to human medicines
  • V: applicable to veterinary medicines

EU GMP guide part I: Basic requirements for medicinal products: Chapter 1: Pharmaceutical quality system (New July 2018)

EU GMP guide part I: Basic requirements for medicinal products: Chapter 3: Equipment

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 5: Production

EU GMP guide part I: Basic requirements for medicinal products: Chapter 8: Complaints, Quality Defects and Product Recalls

EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances

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 annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products

EU GMP guide annexes: Supplementary requirements: Annex 6: Manufacture of medicinal gases

EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol

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 11: Computerised systems

EU GMP guide annexes: Supplementary requirements: Annex 13

EU GMP guide annexes: Supplementary requirements: Annex 16 (Updated May 2018)

EU GMP guide annexes: Supplementary requirements: Annex 19: Reference and retention samples (Updated)

General GMP

GMP certificates, non-compliance statements and manufacturing authorisations

Inspection coordination

Data integrity (New August 2016)

GDP requirements (New June 2018)

Active substance registration (New July 2018)

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