发布时间 : 星期五 文章英国药监局OOS翻译 - 图文更新完毕开始阅读2d35954710661ed9ad51f388
inadequate, a new accurate sampling method must be developed, documented, and reviewed and approved by the Quality Assurance responsible for release. A consideration should be given to other lots sampled by the same method. -如果调查确定原来的取样方法是不适当的，那么新的正确的取样方法需要建立、形成文件、审核、并由放行质量保证负责人批准。使用相同方法取样的其他批次产品应给予考虑。 – An initial OOS result does not necessarily mean the subject batch fails and must be rejected. The OOS result should be investigated, and the findings of the investigation, including retest results, should be interpreted to evaluate the batch and reach a decision regarding release or rejection which should be fully documented.
- 最初OOS结果并不意味着该批产品失败必须不合格。OOS结果应当得到调查，调查的发现，包括复检结果，应当得到解释以评估该批产品，并作出关于放行或拒绝放行的决定，这些应当全面记录归档。
– In those cases where the investigation indicates an OOS result is caused by a factor affecting the batch quality (i.e., an OOS result is confirmed), the result should be used in evaluating the quality of the batch or lot. A confirmed OOS result indicates that the batch does not meet established standards or
specifications and should result in the batch's rejection and proper disposition. Other lots should be reviewed to assess impact.
- 在某些情况下，调查证实OOS结果是因一影响产品质量的因素导致（即：OOS结果被证实），这一结果应用作评价该批产品质量。这个OOS结果表明该批产品达不到已建立的标准，导致该批产品的不放行和适当处理。其他批次也应当回顾分析以评估所受影响。
– For inconclusive investigations — in cases where an investigation:- - 无结论调查 –当调查出现如下情况时：
(1) does not reveal a cause for the OOS test result and 没有找到OOS结果的原因，且
(2) does not confirm the OOS result 没有正式OOS结果
– the OOS result should be given full consideration (most probable cause determined) in the batch or lot disposition decision by the
certifying QP and the potential for a batch specific variation also needs considering. - 质量受权人在决定产品的处理时OOS结果应给与充分的考虑，潜在的产品特有的变化也应当给与考虑。
– Any decision to release a batch, in spite of an initial OOS result that has not been invalidated, should come only after a full investigation has shown that the OOS result does not reflect the quality of the batch. In making such a decision, Quality Assurance/QP should always err on the side of caution. - 尽管最初OOS结果不能证明无效，放行产品的任何决定都只能在完整的调查之后做出，这些调查显示OOS结果不能反映产品质量。最这样一个决定，QA/QP应当宁可更加小心。
Out Of Specification Investigation OOS调查
This is a guidance document that details the MHRA expectations
这是一个详述MHRA期望的指导文件
Note: This guidance is complementary to FDA Guidance For Industry Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production October 2006.
注：这个指导原则是“FDA药品OOS试验结果工业调查 2006年十月”的补充。
Updated to include Microbiological expectations 本更新包括微生物学调查期望