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药典(Pharmacopoeia)是一个国家记载药品规格、标准的法典。大多数由国家组织药典委员会编印,并由政府颁布,具有法律的约束力。药典中规定了常用药物及制剂的质量标准,并将各种检查的具体方法收入附录,各国药典在一定程度上可反映该国家药物生产、医疗和科技的水平。目前,随着中国加入WTO组织,药品的原料及各种制剂的进、出口检验标准及方法均需要参照进、出口国的药典,同时,在进品药品注册及进口药品质量复核时,相应的送审资料中均要求药品质量标准的检验标准及其中译本,并且要求:各类中文翻译件必须忠实原文,并符合中国的专业规范。引用最多的就是药典的附录部分内容。本文将欧洲药典附录中的非无菌产品的微生物限度检查章节译出,希望能给医药界工作者提供参考。
Pharmacopoeia is a national code of practice documenting standards and standards. Most are compiled by the State Organization Pharmacopoeia Commission and promulgated by the government and legally binding. Pharmacopoeia provides for the quality standards of commonly used drugs and preparations, and a variety of inspection methods are included in the appendix, to a certain extent, each country Pharmacopoeia can reflect the country’s drug production, medical and technological level. At present, with China’s accession to the WTO, the inspection standards and methods for the import and export of raw materials and various preparations of pharmaceutical products all need to refer to the pharmacopoeias of importing and exporting countries. At the same time, when registering the imported pharmaceutical products and reviewing the quality of imported pharmaceutical products, The materials submitted for examination all require the testing standards of the pharmaceutical quality standards and their translations, and require that all kinds of Chinese translations must be faithful to the original text and conform to the professional norms of China. Most cited is the Pharmacopoeia appendix part. This article will be the European Pharmacopoeia Appendix of non-sterile products microbial limit inspection chapter translated, hoping to give the medical profession to provide reference.