翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(12)

Validation would then be relatively straightforward, with the typical

parameters listed in the USP in chapter <1225> on validation of compendial methods addressed as applicable.

验证将会相对简单,与典型的USP < 1225 >章列出的参数表中的验证方法同为适用的。

Evaluate the manufacturer's validation report for their stability testing. 通过稳定性测试评估生产商的验证报告。Again, review the raw laboratory data and the results of testing at the various stations to determine if the data actually reported matches the data found in on site records.