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为确保注射剂产品内在质量安全有效,提高可见异物合格率,QC小组统计一定批次数据,对可见异物的数量及类别进行分析,并针对主要原因采取整改措施,且进行效果确认,最终从根本上保证可见异物合格率达到既定目标。
In order to ensure the intrinsic quality of the injection products safe and effective to improve the pass rate of visible foreign bodies, QC group statistics of a certain batch of data on the number and type of foreign bodies were analyzed, and for major reasons to take corrective measures, and to confirm the results, and ultimately radically Assurance of visible foreign body pass rate reached the set goals.