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

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	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 Part I Basic Requirements for Medicinal Products Part II Basic Requirements for Active Substances used as Starting Materials Annexes Glossary Other documents related to GMP
	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

EudraLex Volume 4 Good manufacturing practice (GMP) Guidelines

Introduction

Part I Basic Requirements for Medicinal Products

Part II Basic Requirements for Active Substances used as Starting Materials

Part III GMP related documents

Annexes

Glossary

Other documents related to GMP

EudraLex Volume 4
Good manufacturing practice (GMP) Guidelines