howtodo-Q7A问答中文版.doc

原料药委员会 原料药GMP： “如何实施”文件 ICH-Q7a指南解释 原文：2010年六修订版 翻译：徐禾丰 英-汉对照版 2010年二月，第六版 ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE 原料药委员会 GMPs for APIs: 原料药GMP： “How to do” Document “如何实施”文件 Interpretation of the ICH Q7a Guide ICH-Q7a指南解释 Version 6 版本6  “How to do”-Document “如何实施”-文件 1. INTRODUCTION绪论 1.1 Objective 目的 Historical Background 历史背景 When the initiative was taken by PIC/S at the Canberra meeting in September 1996 to draft a globally harmonised Good Manufacturing Practices (GMP) guide for the Production of Active Pharmaceutical Ingredients (API’s), the recommendation was made that this should essentially be a “what to do”, rather than a “how to do” document. 在1996年九月堪培拉会议上，药品生产检查互认公约合作组织(PIC/S)发起起草一份全球协调的原料药(APIs)生产GMP指南，该推荐在 本质应当是一个“做什么”，而不是一个“怎样做”的文件。 After that initiative the International Conference on Harmonisation (ICH), which consists of the three major pharmaceutical regions of the world-USA, Japan and Europe-took the topic on board. The ICH established an Expert Working Group (EWG) which membership was due to the importance of the topic extended beyond the three regions to WHO, PIC/S members, India, China and OTC and Generic industry representatives. The EWG, of which CEFIC APIC was a member of, has compiled the GMPs for APIs Guide within 2 ? years time. The document was finali