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 |
Q9 Quality Risk Management |
Q10 Note for Guidance on Pharmaceutical Quality System (external link EMA) |
MRA Batch Certificate |
Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use |
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 |
Annex 16 | Certification by a Qualified person and Batch Release |
Annex 17 | Parametric Release |
Annex 19 | Reference and Retention Samples |
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) |