翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(4)

审查和评价实验室用于进行产品不合格调查的标准操作程序，对单一和多个不符合规格标准结果的调查应遵循不同的程序。

For the single OOS result the investigation should include the following steps and these inquiries must be conducted before there is a retest of the sample:

对单一不符合规格标准结果，调查应包括下列步骤，并且这些调查应当在该样品被复检之前进行：

the analyst conducting the test should report the OOS result to the supervisor.

进行检验的化验员应向主管人报告不符合规格标准结果； the analyst and the supervisor should conduct an informal laboratory . 化验员和主管人应进行一次非正式的实验室调查。 investigation which addresses the following areas: 调查范围如下：

1. discuss the testing procedure 1.讨论检验程序； 2. discuss the calculation 2.讨论计算过程； 3. examine the instruments 3.检查仪器；

4. review the notebooks containing the OOS result. 4.审查包含不符合规格标准结果的记录本。

An alternative means to invalidate an initial OOS result, provided the failure investigation proves inconclusive, is the \

如果对不合格结果的调查不能查明原因，—种可以使最初的不符合规格标准结果归于无效的变通方法是做异常值检验。

However, specific restrictions must be placed on the use of this test. 但是使用这种检验应有特别的限制：

1. Firms cannot frequently reject results on this basis. 1.公司不能经常以此为基础否定化验结果；

2. The USP standards govern its use in specific cases only. 2.美国药典标准规定异常值检验只用于特定的情况； 3. The test cannot be used for chemical testing results.

3.该检验不适用于化学分析结果；

An initial content uniformity test was OOS followed by a passing retest. 一个初始含量均匀度测试要通过一个不符合规格标准重复测试。

The initial OOS result was claimed the result of analyst error based on a statistical evaluation of the data.

最初的不符合规格标准结果根据数据的统计评估来表明分析员的误差。 The court ruled that the use of an outlier test is inappropriate in this case.. 在法则中有规定在这种情况下使用异常值检验法是不合适的... 4. It is never appropriate to utilize outlier tests for a statistically based test, i.e., content uniformity and dissolution.

4.以统计为基础的检验(如含量均匀度和溶出度检验)不能用异常值检验。 Determine if the firm uses an outlier test and evaluate the SOP. 确定药厂是否使用异常值检验并评价其不符合规格标准。

Determine that a full scale inquiry has been made for multiple OOS results. 确定对多个不符合规格标准结果是否做了全面的查询。

This inquiry involves quality control and quality assurance personnel in addition to laboratory workers to identify exact process or non process related errors.

这种查询不仅与实验室工作人员有关，也涉及到质量控制和质量保证人员，以便确定误差是否与生产工艺有关。

When the laboratory investigation is inconclusive (reason for the error is not identified) the firm:

当实验室调查不能得出结论(误差原因不明)时，该药厂： 1. Cannot conduct 2 retests and base release on average of three tests 1.不得进行两次复检和根据三次化验的平均值对产品进行放行； 2. Cannot use outlier test in chemical tests 2.不能用异常值检验做化学检验；

3. Cannot use a re-sample to assume a sampling or preparation error 3.不能用重复取样的办法假定取样或制备过程误差；

4. Can conduct a retest of different tablets from the same sample when a retest is considered appropriate (see criteria elsewhere)

4.当确认可以复检时(见另外的标准)，可以取同一样品中的不同药片做复检。

-------------------------------------------------------------------------------王先鸣 C. FORMAL INVESTIGATIONS 正式的调查

Formal investigations extending beyond the laboratory must follow an outline with particular attention to corrective action.

实验室之外的正式调查必须遵循特别注意纠正行动的原则。 The company must: 公司必须：

1. State the reason for the investigation说明调查的原因

2. Provide summation of the process sequences that may have caused the problem

提供可能导致该问题的工序数据的总和

3. Outline corrective actions necessary to save the batch and prevent similar recurrence 概述保留该批生产量和防止同类事件再次发生所必须的纠正措施 List other batches and products possibly affected, the results of …… 此处隐藏：1400字，全部文档内容请下载后查看。喜欢就下载吧 ……