EMEA - Good Manufacturing Practise for Active Pharmaceutical Ingedients

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


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)
Other documents related to GMP
Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures
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