ema制剂成品生产指南-2017(中英文)完整版.docVIP

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 Finishe d 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：Owen Executive summary 综述 This guideline replaces the note for guidance on the manufacture of the finish ed dosage form (CPMP/QWP/486/95). The note for guidance has been updat ed 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 D ocument (CTD) Module 3 dossier. It also addresses current manufacturing pra ctices in terms of complex supply chains and worldwide manufacture. In additi on, the content and principles of the ICH Q8 guideline (ref 1) are also taken int o 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 p roducts for human use. However as stated in article 23 of Directive 2001/83/E C, after a marketing authorisation (MA 上市许可 证) has been approved, the authorisation holder should, in respect of the meth ods of manufacture and control take account of scientific and technical progre ss and introduce any changes that may be required to enable the medicinal pr oduct to be manufactured and controlled by means of generally accepted scie ntific 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 章提到在一份上市许可批准之后，上市许可持有人应该在关于生产方法和控制方 面考虑科学和技术的改进，推行一些被要求的变更，通过一般可接受的科学方法 来进行药品的生产和控制。 1. Introduction (background) 介绍（背景） The objective of the guideline on the manufacture of the finished dosage form is to provide clarification on the type and level of information that should be in cluded in the CTD Module 3 of the marketing authorisation application (MAA 上市许可申请) dossier with respect