2013年FDA警告信中关于不正确的OOS处理举证.pdf

Failures in Handling OOS Results cited in FDA Warning Letters 2013 2013年FDA警告信中关于不正确的OOS处理举证 A review of the 2013 FDA Warning Letters shows that the incorrect handling of OOS results is still a hot topic in FDA inspections and inspection follow up activities (483s, etc.). In total 9 companies received a FDA Warning Letter relating OOS investigations in calendar year 2013.Here are some examples of these OOS citations: 回顾2013 年FDA 的警告信 ，显示不正确的处理OOS 结果仍是在FDA 检查和检查的后续活动 （如 483 ）中的一个热点话题。2013 年中共有9 家公司收到的警告信中涉及到OOS。在这里引用这些OOS 事 例： Your firm did not identify, report, or investigate out-of-specification (OOS) results. 你公司没有识别、报告或调查OOS 结果。 Your firm failed to thoroughly investigate any unexplained discrepancy or failure of abatch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. 你公司没有彻底调查任何原因不明的差异或不合格或任何组分不符合其质量标准，无论是否已销售。 On multiple occasions, you failed to perform failure investigations for rejected batches or implement any preventive actions 在多个场合 ，你们没有 不合格批次执行不合格调查或执行任何防范措施。 The inspection found that your firm failed to perform an investigation for the failure of in-process pH requirements. This failing pH result was confirmed by your QC laboratory. Additionally, you rejected filled sub- lots failed to meet the particle inprocess acceptance criteria, but did not conduct an adequate investigation into that failure. However, you did not provide your determination of actual root cause for this failure to meet in- process limits. 我们检查发现你公司没有 中控PH 不合格进行调查。这个不合格PH 结果已被QC 确认。另外 ，你 们拒绝了微粒不合格的不批 ，但是你们没有 这个不合格进行充足的调查 .然后 ，你们没有提供不符合 中控限度的确定、根本原因。 Our investigator found that you do not determine and implement corrective and preventive actions (CAPAs) in a timely manner to prevent recurrence of manufacturing deviations. 我们调查发现你们没有及时确定和执行CAPAs 以防止生产偏差再次发生。 Your firm released multiple lots of f