FDA工艺验证指南的特点分析

有效的工艺验证对保证药品质量至关重要,2011年1月24日,FDA发布了工艺验证指南《Process Validation:General Principles and Practices》。该指南概况了工艺验证的一般原则和方法,将工艺验证与产品生命周期概念以及现有的FDA/ICH指南进行了整合,如Q8(R2)药品研发、Q9质量风险管理和Q10药品质量体系。从技术审评的角度,对FDA新版工艺验证指南的主要特点进行讨论分析。

Discussion on characteristics of FDA guidance for process validation

Effective process validation contributes significantly to assuring drug quality. On January 24, 2011, the process validation guidance "Process Validation:General Principles and Practices" was issued by FDA. This guidance overviews general principles and methods of process validation, aligns process validation activities with a product lifecycle concept and with existing FDA/ICH guidance, including Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. In this article, the main characteristics of FDA new guidance for process validation are discussed from the view of technical review.