2011年FDA警告信关于OOS处理的不正确案例

蒲公英

2011年FDA警告信关于OOS处理的不正确案例

回顾FDA2011年警告信，有10个关于OOS处理不当的问题。涉及10个公司（6药品制造商和4个原料药制造商）。引用例子如下：

1.      Failure to investigate and document out-of-specification results obtained for …从…出现了OOS没有进行调查与记录。

2.      Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed, and you failed to extend the investigation to other batches of the same drug product that may have been associated with the specific failure or discrepancy. 贵公司没有充分调查批不合格或物料不符合标准，包括已销售产品和未销售产品。而且没有延长到同一产品的不同批次。

3.      Your firm's out-of-specification (OOS) investigations did not include analysis of all available data. 你们公司进行的OOS调查没有对所有数据进行分析。

4.      Inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards. 关键偏差或批不合格调查不充分或没有调查。

5.      Your firm has failed to conduct an investigation for numerous OOS results (e.g., for colony forming units, conductivity, assay, etc.). Many of these OOS results were not reported to your client. 贵公司很多OOS结果没有进行调查（例如，微生物检测，电导率，含量等）。许多OOS结果没有报告你的客户。

6.      Your QCU approved and released a batch of … despite an initial OOS bulk assay result. These results were later confirmed through repeat testing, but further testing of additional samples produced passing results.  Your QCU released the batch even though the investigation did not identify a discernable cause. 你们某批产品出现OOS，你们通过复测合格，质量控制部门就批准放行，即没进行根源调查也没通过重新取样检测。

7.      Your QCU failed to detect multiple discrepancies in sample weights and dilution factors between the analyst's notebook and the Calculation Sheet. As a result, incorrect data was recorded for multiple products and finished products not meeting specifications were released. Specifically, a lot of … was released and distributed even though it did not meet the established specification of … % label claim. The correct calculation would have reported a … % label claim. 你们质量控制部门没有发现记录本的样品称量和稀释错误，导致出现多个产品的数据不正确，产品不符合质量标准。特别是某产品在不符合标示含量的情况放行了该产品。正确的计算结果应为占标示含量的##%。

8.      Your QCU did not require a second, independent person to review the raw data, calculations and records before releasing these lots for distribution. 产品放行销售前，你们质量控制部门没有进行第二人独立复核去审查原始数据、计算和记录。

9.      The inspection also found that your analyst did not record these out-of specification results in the OOS logbook as required by your SOP.检查还发现你们的化验员没有按SOP的要求在记录本上记录OOS结果。

10. Your investigation failed to follow your procedures when your firm … initiated Phase 2 sample testing prior to completing Phase 1 of the investigation, and … only analyzed two samples as opposed to the required three samples 你们的调查不能遵守你们的程序规定。你们公司规定在完成1阶段调查开始第2阶段的抽样测试规定做三个样品，而你们做了2个样品。

华佗

一个未调查，一个调查不彻底，还有就是未严格按照程序执行！

shgmp

这些还是很笼统，如果能和483进行欧联上就好了，这样可以详细看看当时的情况

玻璃杯

我司也通过了FDA的现场检查，API的，感觉FDA也是在风险评估的基础上，对厂商进行检查的。
产品治疗效果确切，而毒副作用又公认很小，FDA也只是履行下程序。

脸妖

围观ing。

dtgyl

实例，很实用。