EMA 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.
Click the links below for complete guidelines
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 (January
2011)
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
(into operation since 31 January 2013)
Chapter 8 - Complaints and Product Recall (into operation since 1 March 2015)
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
Q10 Note for Guidance on Pharmaceutical Quality System
Template for the "written
confirmation" for active substances exported to the European Union for
medicinal products for human use (Version 2, January 2013)
Annexes
Annex 1 Manufacture of Sterile Medicinal Products
Annex 2 New - Manufacture of Biological active substances and Medicinal Products for Human Use (into
operation since 26 June 2018)
Annex 2 is no longer applicable to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.
Annex 3 Manufacture of Radiopharmaceuticals
Annex 5 Manufacture of Immunological Veterinary Medicinal Products
Annex 6 Manufacture of Medicinal Gases
Annex 7 Manufacture of Herbal Medicinal Products
Annex 8 Sampling of Starting and Packaging Materials
Annex 9 Manufacture of Liquids, Creams and Ointments
Annex 10 Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation
Annex 11 Computerized Systems(revision January 2011)
Annex 12 Use of Ionising Radiationin the Manufacture of Medicinal Products
Annex 13 Manufacture of Investigational Medicinal Products
Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation(EU) No 536/2014 (applicable as from the date of entry into
application of Regulation (EU) No 536/2014 on Clinical Trials)
Annex 14 Manufacture of Products derived from Human Blood or Human Plasma
Annex 15 Qualification and validation (into operation since 1 October 2015)
Annex 16 Certification by a Qualified Person and Batch Release (into operation since 15 April 2016)
Annex 17 New - Parametric release (Deadline for coming into operation: 26 December 2018)
Annex 19 Reference and Retention Samples
Part IV - GMP requirements for
Advanced Therapy Medicinal Products
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
EMA EudraLex - Volume 4 - GMP Guidelines: