制剂工艺验证指南---法规申报中要提交的信息和数据-中英翻译版.docx

制剂工艺验证指南---法规申报中要提交的信息和数据-中英翻译版 21 November 2022 EMA/CHMP/CVMP/QWP/BWP/70278/2022-Rev1,Corr.1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on process validation for finished products - information 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 This guideline replaces the note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/5101/101) 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/5101/101），包括附录二----非标准工艺（CPMP/QWP/2054/03）。

21 November 2022 EMA/CHMP/CVMP/QWP/BWP/70278/2022-Rev1,Corr.1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on process validation for finished products - information 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 This guideline replaces the note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/5101/101) 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/5101/101），包括附录二----非标准工艺（CPMP/QWP/2054/03）。