翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(3)

The analytical sections of drug applications usually contain only test results and the methods used to obtain them. Sponsors are not required to file all the test data because such action would require voluminous submissions and would often result in filing redundant information. Sponsors may

deliberately or unintentionally select and report data showing that a drug is safe and effective and deserves to be approved. The inspection team must decide if there is valid and scientific justification for the failure to report data which demonstrates the product failed to meet its predetermined specifications.

药物的应用分析部分通常只包含测试结果和获得他们所采用的方法。发起人不需要提交所有的测试数据，因为这些行动将需要提交大量文件，往往会导致提交冗余信息。发起人可以有意识的选择报告数据来证明药物是安全有效的，值得被批准。检查组必须决定如果有有效和科学的理由报告的数据表明了产品未能达到其预定的规格。

Coordination between headquarters and the field is essential for a complete review of the application and the plant. Experienced investigators and analysts may contact the review chemist (with appropriate supervisory

concurrence) when questions concerning specifications and standards arise. 总部和地区之间的协调是必不可少的一个完整的审查申请和工厂审查。当遇见规范和标准相关的问题时，经验丰富的调查员和分析员可联系的审查化学家适当的监管同意。

Inspections should compare the results of analyses submitted with results of analysis of other batches that may have been produced. Evaluate the

methods and note any exceptions to the procedures or equipment actually used from those listed in the application and confirm that it is the same method listed in the application. The analyst is expected to evaluate raw

laboratory data for tests performed on the test batches (biobatches and clinical batches) and to compare this raw data to the data filed in the application.

检查应比较递交材料的结果和分析以及其他可能已经生产的批次的结果和分析。评估所有列在申请上的方法和注意的例外的程序和设备的实际使用，并确认在申请中列出的是同样的方法。分析员预计评价测试的测试批次（生化批次和临床批次）的实验室原始数据和比较原始数据和申请中的数据文件。

5. FAILURE (OUT-OF-SPECIFICATION) LABORATORY RESULTS 失败（超标）化验结果

Evaluate the company's system to investigate laboratory test failures. These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. 评估该公司的OOS调查系统。这些调查代表一个关键在决定产品是否能被放行或拒绝以及作为重新检测，重新取样的基础。

In a recent court decision the judge used the term \(OOS) laboratory result rather than the term \common to FDA investigators and analysts. He ruled that an OOS result identified as a laboratory error by a failure investigation or an outlier test. The court provided explicit limitations on the use of outlier tests and these are discussed in a later segment of this document., or overcome by retesting. The court ruled on the use of retesting which is covered in a later segment of this document. is not a product failure. OOS results fall into three categories:

在最近的一个法院判决的法官使用术语实验室的结果“超标”（OOS）而不是“产品失败”，这是FDA调查员和分析员更为常用的。他裁定这是一个OOS结果认定为实验室误差通过一个失败的调查或异常值检验。法院提供明确的限制使用异常点检验，这些都是在后面的部分文件。讨论，或克服的复验。法院裁定这将在本文档后面的部分重新测试使用。

不是一个失败的产品。OOS结果分为三类： -- laboratory error实验室错误 -- non-process related or operator error 非相关的过程或操作错误

-- process related or manufacturing process error

工艺或制造过程错误

------------------------------------------------------------------------------尤长友 A. LABORATORY ERRORS 实验室误差

Laboratory errors occur when analysts make mistakes in following the method of analysis, use incorrect standards, and/or simply miscalculate the data.

实验室误差产生于下列情况：化验员未能正确地按分析方法操作；使用不正确的标准和(或)简单地算错了数据。

Laboratory errors must be determined through a failure investigation to identify the cause of the OOS.

实验室误差必须通过一项失败的调查来确定，以便鉴定出造成不符合规格标准的原因。

Once the nature of the OOS result has been identified it can be classified into one of the three categories above.

—旦不符合规格标准结果的性质被确定了，就可以把它归入上述三类中的一类。

The inquiry may vary with the object under investigation. 查询可能会随着调查的目的的不同而变化。

B. LABORATORY INVESTIGATIONS 实验室调查

The exact cause of analyst error or mistake can be difficult to determine specifically and it is unrealistic to expect that analyst error will always be determined and documented.

要确定化验员误差或差错的确切原因是困难的，同时希望化验员误差总能确定和记录下来是不现实的。

Nevertheless, a laboratory investigation consists of more than a retest. 然而，一项实验室调查并不仅限于进行复试。

The inability to identify an error's cause with confidence affects retesting procedures, not the investigation inquiry required for the initial OOS result. 无法有把握地鉴别误差原因会影响复检的程序，而不影响对最初的不符合规格标准结果所要求的调查询问。

The firm's analyst should follow a written procedure, checking off each step as it is completed during the analytical procedure.

药厂化验员应当遵循书面的调查程序，如同完成分析过程—样，核对每一操作步骤。

We expect laboratory test data to be recorded directly in notebooks; use of scrap paper and loose paper must be avoided. These common sense measures enhance the accuracy and integrity of data.

我们希望实验室检验数据能直接记在记录本上，避免使用纸片或活页纸。这些常识性方法可以增强数据的准确性和完整性。

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