翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(9)

Expect to see written justification for the deletion of all files. 期望看到所有文件的删除的书面理由。

Determine the adequacy of the firm's procedures to ensure that all valid laboratory data are considered by the firm in their determination of acceptability of components, in-process, finished product, and retained stability samples.

确定有足够的公司程序以确保所有有效的实验室数据被认为是由该公司在其确定可接受性成分、中间品、成品和保留稳定性的样品。

Laboratory logs and documents when cross referenced may show that data has been discarded by company officials who decided to release the product without a satisfactory explanation of the results showing the product fails to meet the specifications.

实验室记录和文件交叉引用时可能导致数据被公司人员丢失。这些人员决定放行没有令人满意的结果显示产未能符合规定的产品。

Evaluate the justification for disregarding test results that show the product failed to meet specifications.

评估无视显示该产品不符合规定的测试结果的理由。 ----------------------------------------------------------王敏 14. LABORATORY STANDARD SOLUTIONS 14.实验室的标准溶液

Ascertain that suitable standards are being used (i.e. in-date, stored properly). 确定正在使用的标准品是合适的（也就是在有效期内，储存合适的）

Check for the reuse of stock solutions without assuring their stability. 检查是否未确定其稳定性就重复使用储备液。

Stock solutions are frequently stored in the laboratory refrigerator. 储备液通常是储存在实验室的冰箱当中。

Examine the laboratory refrigerators for these solutions and when found check for appropriate identification.

检查实验室冰箱中的溶液，并核实它们的标识是否正确无误。 Review records of standard solution preparation to assure complete and accurate documentation.

审查标准溶液的配制，以确保完整和准确的文件记录。

It is highly unlikely that a firm can \the same microgram.

“准确无误的、始终如一的”称量到同一微克数对任一家公司来说是不切实际的。

Therefore data showing this level of standardization or pattern is suspect and should be carefully investigated.

因此，数据显示，这个级别的标准或模式是值得怀疑的，应该仔细调查研究。

15. METHODS VALIDATION 15.方法验证

Information regarding the validation of methods should be carefully evaluated for completeness, accuracy and reliability.