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.

On this page:
Introduction

 Introduction February 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.

Part I Basic Requirements for Medicinal Products

Chapter 1

Quality Management
(Deadline for coming into operation: 31 January 2013)

Chapter 2

Personnel

Chapter 3

Premise and Equipment

Chapter 4

Chapter 4 Documentation Revision January 2011

Chapter 5

Production

Chapter 6

Quality Control

Chapter 7

on Outsourced activities

Chapter 8

Complaints and Product Recall

Chapter 9

Self Inspection

Part II Basic Requirements for Active Substances used as Starting Materials

Basic Requirements for Active Substances used as Starting Materials

Part III GMP related documents
Site Master File february 2011
Q9 Quality Risk Management (external link EMA)
Q10 Note for Guidance on Pharmaceutical Quality System (external link EMA)
MRA Batch Certificate June 2011
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

Manufacture of Biological Medicinal Products for Human Use

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 Pressurised Metered Dose Aerosol Preparations for Inhalation

Annex 11

Computerised Systems revision January 2011

Annex 12

Use of Ionising Radiation in the Manufacture of Medicinal Products

Annex 13

Manufacture of Investigational Medicinal Products

Annex 14

Manufacture of Products derived from Human Blood or Human Plasma May 2011

Annex 15

Qualification and validation

Annex 16

Certification by a Qualified person and Batch Release

Annex 17

Parametric Release

Annex 19

Reference and Retention Samples

Glossary

Glossary

 Other documents related to GMP

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

Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Last update : 22 February 2013