翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(6)

然而，非过程和过程相关的错误造成的失误，设备（以外的实验室设备）发生故障，或制造的过程，是从根本上的缺陷，如不正确的混合时间的运营商，代表产品故障。

Examine the results of investigations using the guidance in section 5 above and evaluate the decision to release, retest, or rework products.

检查使用指导在上文第5节的调查和评估结果决定释放，复试，或返工的产品。 7.RETESTING 复验

Evaluate the company's retesting SOP for compliance with scientifically sound and appropriate procedures.

评估公司复验的标准操作规程（SOP）是否科学合理。

A very important ruling in one recent court decision sets forth a procedure to govern the retesting program.

在最近的一次非常重要法庭的裁决提出一个决定来指导复验程序。 This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmaceutical laboratory, but should not be considered as law, regulation or binding legal precedent.

这个判决为药物实验室的某些方面的评估提供了一个很好的指南，但不应被视为法律，法规或具有法律约束力的判例。

The court ruled that a firm should have a predetermined testing procedure and it should consider a point at which testing ends and the product is evaluated.

法院裁定,一个公司应该有一个预先确定的测试程序,它应该考虑一个测试结束点和产品评估。

If results are not satisfactory, the product is rejected.

如果结果不理想，该产品将被拒收（销毁）。

Additionally, the company should consider all retest results in the context of the overall record of the product.

此外，公司应该考虑该产品的总记录包含所有的复验结果。

This includes the history of the product. 这包括该产品的历史。

The court ordered a recall of one batch of product on the basis of an initial content uniformity failure and no basis to invalidate the test result and on a history of content uniformity problems with the product., type of test performed, and in-process test results.

法庭下令召回一批产品是由于：初始含量均匀度不合格和没有根据的，无效的测试结果的基础上，在历史的含量均匀度问题的产品，执行的测试类型，测试过程中的测试结果。

Failing assay results cannot be disregarded simply on the basis of acceptable content uniformity results.

失败的试验结果不能简单地被忽略的基础上，可接受的含量均匀度的结果。

The number of retests performed before a firm concludes that an

unexplained OOS result is invalid or that a product is unacceptable is a matter of scientific judgment.

之前，公司进行的复验结论是一种原因不明的OOS结果是无效的，或产品是不能接受的是科学判断的问题。

The goal of retesting is to isolate OOS results but retesting cannot continue ad infinitum.

复验的目的是隔离OOS的结果，但不能继续再测试循环往复。 In the case of nonprocess and process-related errors, retesting is suspect. 在非过程和过程相关的错误的情况下，重新测试的嫌疑。 Because the initial tests are genuine, in these circumstances, additional testing alone cannot contribute to product quality.

因为最初的试验是真实的，在这种情况下，额外的单独测试可以有助于产品质量。

The court acknowledged that some retesting may precede a finding of nonprocess or process-based errors.

法院承认，一些重新测试之前发现的非过程或过程为基础的错误。 Once this determination is made, however, additional retesting for purposes of testing a product into compliance is not acceptable.

一旦作出该判定，但是，为了遵守测试产品的目的的额外复检是不能接受的。

For example, in the case of content uniformity testing designed to detect variability in the blend or tablets, failing and non-failing results are not inherently inconsistent and passing results on limited retesting do not rule out the possibility that the batch is not uniform.

例如，在含量均匀度测试旨在检测变异的混合物或片，失败和失败的结果是不是本身就是矛盾的，通过在有限的复验结果的情况下，不排除可能的批次是不统一的。

As part of the investigation firms should consider the record of previous batches, since similar or related failures on different batches would be a cause of concern.

作为调查公司的一部分，应考虑前面的批次，不同批次的自相似或相关的故障记录，将是一个值得关注的问题。

Retesting following an OOS result is ruled appropriate only after the failure investigation is underway and the failure investigation determines in part whether retesting is appropriate.

重新测试后的OOS结果被排除适当失败后的调查正在进行中，部分故障的排查确定是否是合适的复验。

It is appropriate when analyst error is documented or the review of analyst's work is \non-process or process related errors.

这是适当的时候分析师记录错误或审查分析师的工作是“不确定”，但它并不适合已知的和无可争议的进程或进程相关的错误。 The court ruled that retesting: 法院裁定，重新测试：

must be done on the same, not a different sample 必须是相同的，而不是一个不同的样本上进行

may be done on a second aliquot from the same portion of the sample that was the source of the first aliquot

可以做的第二等分试样从样品的相同部分的第一等分试样的来源 may be done on a portion of the same larger sample previously collected for laboratory purposes

可以完成相同的较大的样本以前收集的一部分上，用于实验室用途 -------------------------------------------------------------- 李杰 8. RESAMPLING （再取样）

Firms cannot rely on resampling. The court ordered the recall of one batch of product after having concluded that a successful resample result alone cannot invalidate an initial OOS result. to release a product that has failed testing and retesting unless the failure investigation discloses evidence that the original sample is not representative or was improperly prepared. 药厂不得依赖再取样。法院下令召回一批产品后，得出的结论是一个成功的重采样的结果，不能单独判断最初的检验结果偏差结果是无效。为此来发放经检验和复检均不合格的产品，除非对不合格结果的调查查出证据表明原样品不具有代表性或准备不当。

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