原料药清洁验证的程序

摘要

新版GMP实施后，为最大限度地降低药品生产过程中污染、交叉污染等风险，必须进行清洁验证。而在实际操作中，有一些人特别是新参加工作的人不清楚清洁验证将按照什么程序来进行。笔者在此根据本人工作经验和相关法规要求，对清洁验证的程序按照时间先后顺序一一列出，并对每一步应完成的工作进行总结。%After the implementation of new edition of GMP, to minimize the risk of contamination, cross-contamination etc. in the drug manufacturing course, conducting cleaning validation is necessary. But in actual operating practices, some people, especially new employee are not sure how to carry out cleaning validation. According to author’s experience and requirements of relevant regulations, this text lists cleaning validation procedure step by step, and provides details on how to complete each step.