title: [Microbiological and biological methods of the European Pharmacopoeia. Relevant for each medicinal product].
abstract: According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland, Jochen.Norwig@bfarm.de.
authors.forename: J
authors.initials: J
authors.lastname: Norwig
mesh_terms: D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000145:classification* / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations