美国APP公司警告信李永康.docVIP

FDA无菌药品检查风向标 2012年2月22日FDA给美国APP公司（无菌药品生产厂）发布了警告信，主要内容摘译如下。从这个警告信中，我们可以得到FDA对无菌药品生产与控制的关注点与检查新动向，从而不断的自我完善与提升，非常有意义。1) Your firm has not thoroughly investigated any unexplained discrepancy whether or not the batch has already been distributed [21CFR § 211.192]. For example: ?你们公司没有充分对原因不明的偏差进行调查，包括销售的或未销售的产品批次。 a. In January 2010, your firm identified an insect floating in a waste container in aseptic filling room (b)(4). During your root cause analysis, you stated that the most likely cause was the stopper supplier; however, you did not conduct an audit of the supplier until April 2011. In ad