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
• Current(34 KB)
• Deadline for coming into operation: 1 March 2015(146 KB)
• Chapter 4 Documentation (January 2011) (33 KB)
• Chapter 5 Production
• Current(50 KB)
• Deadline for coming into operation: 1 March 2015(251 KB)
• Chapter 6 Quality Control (45 KB)(into operation since 1 October 2014)
• 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
• Current(18 KB)
• Deadline for coming into operation: 1 March 2015(266 KB)
• 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(614 KB) (NEW August 2014)

 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	Manufacture of Sterile Medicinal Products (122 KB)
Annex 2	Manufacture of Biological active substances and Medicinal Products for Human Use(171 KB) ((into operation since 31 January 2013)
Annex 3	Manufacture of Radiopharmaceuticals(68 KB)
Annex 4	Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products(14 KB)
Annex 5	Manufacture of Immunological Veterinary Medicinal Products(43 KB)
Annex 6	Manufacture of Medicinal Gases (48 KB)
Annex 7	Manufacture of Herbal Medicinal Products(23 KB)
Annex 8	Sampling of Starting and Packaging Materials(20 KB)
Annex 9	Manufacture of Liquids, Creams and Ointments(13 KB)
Annex 10	Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation(17 KB)
Annex 11	Computerised Systems (revision January 2011) (22 KB)
Annex 12	Use of Ionising Radiation in the Manufacture of Medicinal Products(50 KB)
Annex 13	Manufacture of Investigational Medicinal Products(67 KB)
Annex 14	Manufacture of Products derived from Human Blood or Human Plasma(50 KB) - May 2011
Annex 15	Qualification and validation (136 KB) A revised version on Annex 15 is in preparation.  The public consultation on the proposed draft (141 KB) (141 KB)is closed
Annex 16	Certification by a Qualified person and Batch Release(41 KB)  A revised version of Annex 16 is in preparation. The public consultation on the proposed draft(150 KB) is closed
Annex 17	Parametric Release(124 KB)
Annex 19	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).