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

Update 05.09.2018

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, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational 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.

- Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
- 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
Chapter 4 - Documentation
Chapter 5 - Production (into operation since 1 March 2015)
- - See transitional arrangement for toxicological evaluation on pages 1-2 of Chapter 5
- - Previous version
- Chapter 6 - Quality Control (into operation since 1 October 2014)
- Chapter 7 - Outsourced activities
- Chapter 8 - Complaints and Product Recall (into operation since 1 March 2015)
- Chapter 9 - Self Inspection

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)

Annexes

Glossary

- Glossary

Part IV - GMP requirements for Advanced Therapy Medicinal Products

- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

Other documents related to GMP

- Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures

- 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.

https://ec.europa.eu/health/documents/eudralex/vol-4_it