Annex 3Manufacture of Radiopharmaceuticals Annex 4Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5Manufacture of Immunological Veterinary Medicinal Products Annex 6Manufacture of Medicinal Gases Annex 7Manufacture of Herbal Medicinal Products ...
EUDRALEX: The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products, Annex 15, Qualification and Validation, 2001.European Commission. EudraLex--The Rules Governing Medicinal Products in the European Union. Vol....
The FDA’s 21 CFR Part 11 and the EU’s EudraLex Volume 4 Annex 11 outline standards for electronic records and signatures in GMP-regulated industries. These regulations ensure that electronic documentation is as reliable and secure as paper-based systems, facilitating...
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 Directiv...