European Commission Public health

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 (33 KB) (7/02/2011)

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.

Part I - Basic Requirements for Medicinal Products

Chapter 1 Pharmaceutical Quality System (65 KB)into (into operation since 31

January 2013)
Chapter 2 Personnel (58 KB)(into operation since 16 February 2014).
Chapter 3 Premise and Equipment (34 KB)
o A revised version of Chapter 3 is in preparation. The public consultation on the
proposed draft (53 KB)is currently closed.
Chapter 4 Documentation (January 2011) (33 KB)
Chapter 5 Production (50 KB)
o A revised version of Chapter 5 is in preparation. The public consultation on the
proposed draft (84 KB)is currently closed.
Chapter 6 Quality Control
o Current (33 KB)
o Deadline for coming into operation: 1 October 2014 (42 KB)
Chapter 7 on Outsourced activities (21 KB) (into operation since 31 January 2013)
Chapter 7 Contract Manufacture and Analysis (22 KB)
Chapter 8 Complaints and Product Recall (18 KB)

A revised version of Chapter 8 is in preparation. The public consultation on the

proposed draft (79 KB)is currently closed
Chapter 9 Self Inspection (11 KB)

Part II - Basic Requirements for Active Substances used as

Starting Materials

Basic requirements for active substances used as starting materials

(452 KB)

Part III - GMP related documents

Site Master File (33 KB)

Q9 Quality Risk Management
Q10 Note for Guidance on Pharmaceutical Quality System
MRA Batch Certificate (101 KB)
Template for the 'written confirmation' for active substances exported to the European
Union for medicinal products for human use (487 KB)(Version 2, January 2013)

Annexes
Table
Eudralex
Annex 1
Annex 2
Annex 3
Annex 4
Annex 5
Annex 6
Annex 7
Annex 8
Annex 9
Annex 10
Annex 11
Annex 12
Annex 13
Annex 14

Manufacture of Sterile Medicinal Products (122 KB)

Manufacture of Biological active substances and Medicinal Products for Human
Use (171 KB) ((into operation since 31 January 2013)
Manufacture of Radiopharmaceuticals (68 KB)
Manufacture of Veterinary Medicinal Products other than Immunological
Veterinary Medicinal Products (14 KB)
Manufacture of Immunological Veterinary Medicinal Products (43 KB)
Manufacture of Medicinal Gases (48 KB)
Manufacture of Herbal Medicinal Products (23 KB)
Sampling of Starting and Packaging Materials (20 KB)
Manufacture of Liquids, Creams and Ointments (13 KB)
Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation (17
KB)
Computerised Systems (revision January 2011) (22 KB)
Use of Ionising Radiation in the Manufacture of Medicinal Products (50 KB)
Manufacture of Investigational Medicinal Products (67 KB)
Manufacture of Products derived from Human Blood or Human Plasma (50 KB) May 2011

Qualification and validation

Annex 15

(136 KB)

A revised version on Annex 15 is in preparation. Stakeholders are invited to

comment on thisdraft
(141 KB)by 31 May 2014.
Comments should be sent by e-mail to: ADM-GMDP@ema.europa.eu and sancopharmaceuticals-D6@ec.europa.eu.
Please consult the privacy statement on this consultation. (82 KB)
Certification by a Qualified person and Batch Release (41 KB)
Deutsch (de)
(el) espaol (es) franais (fr) italiano (it) Nederlands (nl)

Annex 16

Annex 17
Annex 19

A revised version of Annex 16 is in preparation. The public consultation on the

proposed draft (150 KB) is closed
Parametric Release (124 KB)
Reference and Retention Samples (24 KB)

Glossary

Glossary

(27 KB)

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).

10 April 2014
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