FDA 发布 Q2(R1)《分析程序验证：正文与方法学》最终指南（Docket No. FDA-2017-D-6821）
Q2(R1) Validation of Analytical Procedures: Text and Methodology
FDA 于2021年9月将 Q2B《分析程序验证：方法学》（1997年5月）与母文件 Q2A《分析程序验证正文》（1995年3月）合并，重新命名为 Q2(R1)《分析程序验证：正文与方法学》。该最终指南由 CBER 与 CDER 发布，内容由已发布的 Q2A 和 Q2B 组成，实质与两文件及2005年11月 ICH Q2(R1) 指南一致。
GUIDANCE DOCUMENT
Final Level 2 Guidance
- Docket Number:
- FDA-2017-D-6821
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
September 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1). This guidance consists of the previously published FDA guidances, Q2A and Q2B. It is the same, in substance, as those two guidances, and it is the same, in substance, as the November 2005 ICH Q2(R1) guideline.
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来源：FDA Pharmaceutical Quality Documents · fda.gov