EMA工艺验证指引

EMA 工艺验证指南 ---EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 27 February 2014 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on process validation for finished products - ination and data to be provided in regulatory submissions 制剂工艺验证指南---在法规提交中要提供的资料和数据 Draft agreed by CHMP/CVMP Quality Working Party2 February 2012 由 CHMP/CVMP 质量工作组通过草案 Adoption by CVMP for release for consultation CVMP 同意公开征求意见 Adoption by CHMP for release for consultation CHMP 同意公开征求意见 End of consultation (deadline for comments) 征求意见结束（截止日期） Agreed by QWP 由 QWP 通过 Agreed by BWP 由 BWP 通过 Adoption by CHMP 由 CHMP 采用 Adoption by CVMP 由 CVMP 采用 2012 年 2 月 2 日 8 March 2012 2012 年 3 月 8 日 15 March 2012 2012 年 3 月 15 日 31 October 2012 2012 年 10 月 31 日 8 November 2013 2013 年 11 月 8 日 13 November 2013 2013 年 11 月 13 日 19 December 2013 2013 年 12 月 19 日 15 January 2014 2014 年 1 月 15 日 Date for coming into effect6 months after publication 生效日期公布后 6 个月 Thisguidelinereplacesthenoteforguidanceonprocessvalidation(CPMP/QWP/848/96, EMEA/CVMP/598/99) including annex II – non-standard processes (CPMP/QWP/2054/03). 本指南替代工艺验证注释（ CPMP/QWP/848/96, EMEA/CVMP/598/99），包括附录二 ----非标准工艺（CPMP/QWP/2054/03）。 Process validation, continuous process verification, on-going process verification, critical Keywords process parameter, critical quality attribute, lifecycle, change control 关键词工艺验证、持续工艺确认、关键工艺参数、关键质量属性、生命周期、变更控制 Table of contents目录 cutive summary实施摘要 1. Introduction (background) 2. Scope 3. Legal basis 4. General considerations 5. Process validation 5.1. Traditional process validation 5.2. Continuous process verification 介绍（背景）范围法规依据一般考虑工艺验证传统工艺验证持续工艺确认 5.3. Hybrid approach 5.4. Design space verification 6. Scale-up 7. Post approval change control 混合方案设计空间确认放大生产批准后变更控制 8. Standard vs. non-standard s of manufacture 标准 VS 非标准生产方法 Definitions定义 References Annex I: Process validation scheme 参考文献附录 I：工艺验证计划 Annex II: Standard/non-standard processes附录 II：标准/非标工艺 cutive summary 实施摘要 This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, orinstead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10. 本指南替代之前的工艺验证指南解释(CPMP/QWP/848/96, EMEA/CVMP/598/99)。本指南与 ICH Q8， Q9 和 Q10 文件相一致，提供在之前加入和鼓励采用的传统工艺验证这外，提供了使用持续工艺确认的可能性。本指南对已批准上市的药品未引入新要求，但阐述了公司在 ICH Q8, Q9 和 Q10 中描述的有效质量体系下，应用强化工艺理解与风险管理工具时，如何抓住所给的新的可能性。 1. Introduction (background) 介绍（