Norwig J
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Oct;57(10):1158-68. doi: 10.1007/s00103-014-2032-2.
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.
根据欧盟指令2001/83，《欧洲药典》是欧盟的官方药典。因此，《欧洲药典》是德国法定的药典汇编之一。德国市场上的任何许可药品，如适用，均符合药典各论的要求。由于《欧洲药典》中关于剂型、药用物质和药物制剂的通用各论引用了药典的微生物学和生物学方法，这些方法也适用于药品。本文对《欧洲药典》的微生物学和生物学方法进行了简要概述，旨在激发读者更好地理解原始药典。此处提及的方法简短描述是来自药典以及关于《欧洲药典》文本的非官方评论集。
