A brief overview of EU GMP

EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.  

These guidelines are available free of charge and we have collated them here for easy download.   

EU GMP Annex 1: Manufacture of Sterile Medicinal Products

EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use

EU GMP Annex 3: Manufacture of Radiopharmaceuticals[1].pdf

EU GMP Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products[1].pdf

EU GMP Annex 5: Manufacture of Immunological Veterinary Medicinal Products

EU GMP Annex 6: Manufacture of Medicinal Gases

EU GMP Annex 7: Manufacture of Herbal Medicinal Products

EU GMP Annex 8: Sampling of Starting and Packaging Materials

EU GMP Annex 9: Manufacture of Liquids, Creams and Ointments

EU GMP Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

EU GMP Annex 11: Computerised Systems

EU GMP Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products

EU GMP Annex 13: Investigational Medicinal Products

EU GMP Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma

EU GMP Annex 15: Qualification and Validation

EU GMP Annex 16: Certification by a Qualified Person and Batch Release

EU GMP Annex 17: Real Time Release Testing and Parametric Release

EU GMP Annex 18: NOT IN USE 

EU GMP Annex 19: Reference and Retention Samples