EUDRALEX
Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice

Introduction
  Introduction
  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 (revision October 2005)
Chapter 2 Personnel
Chapter 3 Premise and Equipment
Chapter 4 Documentation
Chapter 5 Production
Chapter 6 Quality Control
Revised version (October 2005) including on-going stability programme, coming into operation on 1 June 2006
Chapter 7 Contract Manufacture and Analysis
Chapter 8 Complaints and Product Recall (revision December 2005)
Chapter 9 Self Inspection
 

Part II - Basic Requirements for Active Substances used as Starting Materials
  Basic Requirements for Active Substances used as Starting Materials
 

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
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
Annex 15 Qualification and validation (July 2001)
Annex 16 Certification by a Qualified person and Batch Release (July 2001)
Annex 17 Parametric Release (July 2001)
Annex 18 Good manufacturing practice for active pharmaceutical ingredients
  requirements for active substances used as starting materials from October 2005 covered under part II

Annex 19

 Reference and Retention Samples (December 2005)
 

Glossary
 

Other documents related to GMP

  
  Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures
flag CE European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals - Last update : 26/01/07