EMA制剂成品生产指南2017(中英文)VIP专享

EMA 制剂成品生产指南-2017 4 JJuly 2017 EMA/CHMP/QWP/245074/2015 Committee for Human Medicinal Products (CHMP) Guideline on manufacture of the finished dosage form 制剂成品生产指南 This guideline replaces the “Note for Guidance on Manufacture of the Finished Dosage Form” (CPMP/QWP/486/95) 原创：2017-09-19 翻译组 GMP 办公室 翻译：王世华 校对：Ow en Executive summary 综述 This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline (ref 1) are also taken into account. 这份指南取代了制剂成品生产指南的条款（CPMP/QWP/486/95），指南条款的更新反映了当前已提出的立法机构指令2001/83/EC 的要求，并且遵循通用技术文件模块3 文件的格式和内容。从复杂的供应链和世界范围内生产的方面看，她也代表了当前的生产活动。另外，也应考虑 ICH Q8 指南的内容和原则。 This guideline does not introduce new requirements on authorised medicinal products for human use. However as stated in article 23 of Directive 2001/83/EC, after a marketing authorisation (MA 上市许可证) has been approved, the authorisation holder should, in respect of the methods of manufacture and control take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and controlled by means of generally accepted scientific methods. 这份指南没有对已授权的人用药品给出新的要求，然而在指令2001/83/EC 23...