美国APP公司警告信李永康.doc

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 addition, you stated that there was a pest control program in place, therefore, no corrective action was needed. You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial. You also stated a potential root cause was the gowning supplier; however, your audit of this supplier was not scheduled to be conducted until December 2011. You did not adequately investigate the original deviation for an insect in the sterile manufacturing area and did not implement appropriate corrective actions to prevent recurrence. 在2010年1月，贵公司发现一个昆虫浮在某无菌灌装室的废物容器中。在你们的根源分析说，最大可能原因是供应商；然而，直到2011年4月你们并没有对供应商进行审计。此外，你们说已建立了虫害控制程序，但是缺少纠正行动。你们公司持续又发现了昆虫（2瓶），你们过去已收到过小瓶中发现昆虫的投诉。你们说潜在的根本原因是服装供应商；然而，直到2011年12月你们并没有对供应商做出审计安排。你们对无菌生产区发现昆虫的偏差没有进行充分的调查，也没有采取适当的纠正预防行动。 b. Your firm has received seven complaints for vials with missing labels between January 2010 and July 2011. Four of these complaints involve Packaging Line (b)(4); however, in your complaint investigation# (b)(4), you state that this is the only complaint of this type for this lot and no further action is required. 从2010年1月到2011年7月，你们公司收到7次药瓶缺少标签的投诉。其中4起投诉涉及到该包装线；但是在你们的投诉调查中称：该种投诉仅仅这个批次的第一次，你们没有采取必要的行动。 In your response, you describe enhancements to your reserve room procedures and your complaint management procedure; however, you failed to identify a trend