Inspectional Guidance-How to Investigate a Microbiological OOS test result(s)
调查指导-如何调查微生物OOS测试结果
1. When a firm has an end product test result that indicates a failure (USP test failure, OOS, etc) the inevitable question is –Were the results laboratory error or a true process contamination? Below are a few starter questions to help in your FDA review of the firm’s investigative report.
当一家公司的最终产品测试结果表明存在问题（USP测试失败，OOS等）时，不可避免的问题是 – 结果是实验室错误还是真正的过程污染？以下是一些有助于FDA审查公司调查报告的初步问题。
2. During the subsequent investigation, there are two areas for the review to focus: the manufacturing site and the laboratory that determined the OOS result. The following review questions suggest possible variables that may impact the final conclusions. The investigations may run concurrently between manufacturing and the laboratory. For ease of review I listed my questions first with manufacturing and secondly with laboratory data. I divided the manufacturing review into aseptic manufacturing (High risk) and terminally sterilized products (low risk). Part two covers those questions that I would ask for a critical review of the microbiological data accumulated for the Sterility failures, Microbial limits failures, etc.
在后续调查中，有两个方面需要重点审查：生产现场和确定OOS结果的实验室。以下审查问题提出了可能影响最终结论的变量。调查可在生产车间和实验室之间同时进行。为了便于审查，我首先列出了我的问题和车间，其次是实验室数据。我将车间生产审查分为无菌制造（高风险）和最终灭菌产品（低风险）。第二部分涵盖了我将要求对无菌失败、微生物限度失败等累积的微生物数据进行关键审查的那些问题。
本文来自Pharmaceutical Microbiology Manual2014
免责声明：上述内容仅供交流学习使用，对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。仅作参考，并请各位自行承担全部责任。版权归原作者所有，如遇版权问题请联系小编删除。
你的点的每一个好看，我都认真当成了喜欢
原文始发于微信公众号（药品微生物检测）：Inspectional Guidance 5-如何调查微生物OOS测试结果
