翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(10)

关于方法验证资料的评估应充分考虑其完整性、准确性和可靠性。

In particular, if a compendial method exists, but the firm chooses to use an alternate method instead, they must compare the two and demonstrate that the in-house method is equivalent or superior to the official procedure. 特别是，如果存在一个药典检验方法，但公司选择的是另一种方法，那么，他们必须比较这两者，并证明自己采用的方法等同或优于药典的方法。

For compendial methods firms must demonstrate that the method works under the actual conditions of use.

企业必须证明检验方法的使用是在药典规定的条件下使用的。 Methods can be validated in a number of ways. 检验方法有多种验证方式。

Methods appearing in the USP are considered validated and they are considered validated if part of an approved ANDA.

USP上的方法以及ANDA批准的方法都被认为是验证过的。 Also a company can conduct a validation study on their method.System suitability data alone is insufficient for and does not constitute method validation.

此外，公司也可以对他们自己的方法进行有效性验证，但是系统适应性数据本身并不够，不能构成方法验证。

In the review of method validation data, it is expected that data for repetitive testing be consistent and that the varying concentrations of test solutions provide linear results.

在审查方法验证的数据时，希望复检的数据具有一致性，不同浓度的测试溶液提供了线性的结果。

Many assay and impurity tests are now HPLC, and it is expected that the precision of these assays be equal or less than the RSD's for system suitability testing.

现在用于测试含量和杂质的高效液相色谱法，其测试的精度等于或小于系统适用性试验的RSD。

The analytical performance parameters listed in the USP XXII, <1225>, under the heading of Validation of Compendial Methods, can be used as a guide for determining the analytical parameters (e.g., accuracy, precision, linearity, ruggedness, etc.) needed to validate the method.

在USP XXII, <1225>中（药典方法验证标题下）列出的分析性能参数，可作为指南，以确定验证方法所需要的分析参数（例如准确度，精密度，线性，耐用性等）。 16. EQUIPMENT 16.仪器设备

Laboratory equipment usage, maintenance, calibration logs, repair records, and maintenance SOPs also should be examined.

检查实验室仪器设备的使用，维护保养情况，校正记录，维修记录及维护的标准操作规程。

The existence of the equipment specified in the analytical methods should be confirmed and its condition noted.

确认是否具备在分析方法中使用的专用设备并注意其状态。 Verify that the equipment was present and in good working order at the time the batches were analyzed.

检验每个批次产品时，应确保所涉及的已验证设备都在场并处于良好的工作状态。

Determine whether equipment is being used properly. 确定设备的使用是否正确。

In addition, verify that the equipment in any application was in good working order when it was listed as used to produce clinical or biobatches. 此外，如果有设备用于临床生产或生化小试品研究，应确认它在任何时候的使用当中是否都处于良好状态。

One would have to suspect the data that are generated from a piece of equipment that is known to be defective. 人们会怀疑一台有缺陷的设备所产生的数据。

Therefore, continuing to use and release product on the basis of such equipment represents a serious violation of CGMP's.

因此，继续使用该设备并在此基础上发布产品时严重违反CGMP条例的。

-----------------------------------------------陈淑贤 17. RAW MATERIAL TESTING 原辅料检验