EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

Introduction

• Introduction (07/02/2011)
• Commission Directive 2003/94/EC of 8 October 2003, repealed by Commission Directive 2017/1572/EU of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use.
• Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
• Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
• Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
• Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Part I - Basic Requirements for Medicinal Products

• Chapter 1 - Pharmaceutical Quality System (into operation since 31 January 2013)
• Chapter 2 - Personnel (into operation since 16 February 2014)
• Chapter 3 - Premise and Equipment (into operation since 1 March 2015)
  • See transitional arrangement for toxicological evaluation on page 1 of Chapter 3
  • Previous version
  • See transitional arrangement for toxicological evaluation on pages 1-2 of Chapter 5
  • Previous version

  Part II - Basic Requirements for Active Substances used as Starting Materials

  • Basic requirements for active substances used as starting materials (August 2014)

  Part III - GMP related documents

  • Site Master File
  • Q9 Quality Risk Management
  • Q10 Note for Guidance on Pharmaceutical Quality System
  • MRA Batch Certificate
  • Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use (Version 2, January 2013)
  • Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
  • Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (all language versions are available here). A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016.
  • Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
  • Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
  • Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

  Annexes

  New - Manufacture of Sterile Medicinal Products - The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024

  Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

  Glossary

  Part IV - GMP requirements for Advanced Therapy Medicinal Products

  Other documents related to GMP and GDP

  • Compilation of Union Procedures on Inspections and Exchange of Information
  • A revised version of the "Guidelines on Good Distribution Practice of Medicinal Products for Human Use" was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013)
  • Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (all language versions are available here). These guidelines will come into operation on 21 September 2015
  • Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6
  • Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6
  • Guidance on good manufacturing practice and good distribution practice: Questions and answers