Guidelines EUDRALEX :

Volume 4 : Medicinal products for human and veterany uses  :
Good Manufactory Practices
( http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm)

• Introduction
• Chapter 1 Quality Management
• Chapter 2 Personnel
• Chapter 3 Premise and Equipment
• Chapter 4 Documentation
• Chapter 5 Production
• Chapter 6 Quality Control
• Chapter 7 Contract Manufacture and Analysis
• Chapter 8 Complaints and Product Recall
• Chapter 9 Self Inspection

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 (version française)
•   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
•   Revision of Annex 13
•   Annex 14 Manufacture of Products derived from Human Blood or Human Plasma (Version française.)
•   Annex 15 Qualification and validation (July 2001 - version française)
•   Annex 16 Certification by a Qualified person and Batch Release (July 2001- version française)
•   Annex 17 Parametric Release (July 2001 - version française)
•   Annex 18 Good manufacturing practice for active pharmaceutical ingredients (July 2001)
•   Glossary

Toute remarque concernant ce site peut être envoyée à
Jean Cumps - Faculé de Médecine UCL - Ecole de Pharmacie - TPAO