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值此2000年版药典出版发行、执行之际,为了更好地理解药典中无菌和微生物限度检查法的增、修订内容;了解药品微生物质量控制在制药行业及质量检验中的重要性;以及今后发展的方向,特将美国FDA《药品质量控制微生物实验室检查指南》一文翻译推荐给大家。通过该文,可以了解和借鉴FDA的一些先进的观点。如:对化学、生化药品是否需要进行微生物限度检查?如何评价微生物污染在非无菌药品中的重要性。制订非无菌药品微生物限度的原则。无菌和微生物限度检查的培养时间、初试阳性结果后,是否复试及如何复试的规定。微生物实验中建立阳性、阴性对照的重要性。参加检查或验收微生物实验室时应重视和注意的问题等。
On the occasion of the publication and issue of the 2000 edition of the Pharmacopoeia, on the occasion of the implementation, in order to better understand the additions and amendments of the aseptic and microbial limit test in Pharmacopoeia, understand the importance of quality control of pharmaceutical micro-organisms in the pharmaceutical industry and quality inspection, and in the future The direction of development, especially the United States FDA “Drug Quality Control Microbiology Laboratory Guide” a translation for everyone. Through this article, you can understand and learn from some of the advanced FDA point of view. Such as: the chemical, biochemical drugs need to check the limits of microorganisms? How to evaluate the importance of microbial contamination in non-sterile drugs. Develop non-sterile drug microbial limits of principle. Aseptic and microbial limit of culture time, after the first positive test, whether the retest and how to retest the provisions. The importance of establishing positive and negative controls in microbial experiments. Participate in inspection or acceptance of microbiology laboratory should pay attention to and attention problems.