GMP News
30/07/2015
FDA Guidance on analytical procedures and methods validation published
FDA公布分析方法验证指南
题为“药品和生物制品分析方法验证”的指南于2015年7月27日由FDA公布。它取代2014年2月公布的草案。
Apart from editorial amendmends the current guidance differs from the previous version mainly with respect to the following aspects:
除了一些编辑方面的修订外，现行指南在以下方面与前版本有差异：
- A risk based approach on the need for revalidation of existing analytical methods is encouraged when changes in the manufacturing process occur during the product's lifecycle. Likewise applicants are required to periodically evaluate the appropriateness of a product's analytical methods in case of new information e.g. regarding the product CQAs or the impurity profile. New or alternative analytical methods based on risk assessments should then be considered.
- 在产品的生命周期中发生生产工艺变更时，鼓励采用基于风险的方法对现有分析方法的再验证需求进行评估。同时，如果有关于产品的CQA或杂质概况的新信息时，申报者需要定期评估产品的分析方法的适当性。这时应基于风险评估考虑是否需要有新的或替代的分析方法。
- Appropriate statistical methods should be selected among the variety of statistical techniques and appropriate literature should be consulted for information on statistical procedures when
- 在以下过程中，应从众多统计技术中选择适当的统计方法，应参考适当的文献来获取统计程序方法的信息
- developing new test methods
- 研发新的分析方法时
- evaluating existing test methods
- 评估已有分析方法时
- evaluating measurement system performance
- 评估测量系统性能时
- interpreting or treating of analytical data like determining equivalence of two test methods.
- 诠释或处理分析数据，如决定2个分析方法之间的等效性时
Important: the data analysis should be assured either by using appropriately validated software or independent verification for correctness.
重要：应使用适当的经过验证的软件，或对软件正确性进行独立的确认，以确保数据分析的正确性。
Moreover chapter X. "References" has been updated by including revised gudelines, newly edited articles and three ASTM Standard Guides.
另外第10章“参考文献”进行了更新，包括了修订的指南、新编条款和3个ASTM标准指南。