ICH指导原则Q11原料药开发和生产(化学实体和生物技术生物实体).docVIP

GMP May 2011 EMA/CHMP/ICH/425213/2011 ICH/ Committee for medicinal products for human use (CHMP) ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) ICH 指导原则 Q11 原料药的开发和生产(化学实体和生物技术/生物实体) Step 3 翻译/审核：谢永/Chank Transmission to CHMP Adoption by CHMP for release for consultation End of consultation n (deadline for comments)  May 2011 May 2011 September 2011 Comments Should be provided using this template. The Completed comments form should be sent to ICH@ema.europa.eu 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail ich@ema.europa.eu Website www.ema.europa.eu An agency of the European Union ? European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) TABLE OF CONTENTS 目录 1. INTRODUCTION 介绍 ................................................................................................................. 4 2. SCOPE 范围............................................................................................................................................... 4 3. MANUFACTURING PROCESS DEVELOPMENT 制造工艺开发 .................................................................... 5 3.1. General Principles 总则................................................................................................................................................... 5 3.1.1. Drug Substance Quality Link to Drug Product 将原料药质量与制剂药品联系起来.............. 5 3.1.2. Process Development Tools 工艺开发工具........................................................................... 5 3.1.3. Approaches to Development 开发的方法 .................................................................