EMA EudraLex - Volume 4 - GMP Guidelines


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)

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



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Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products,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 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

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:


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