原料药检查备忘（中英文）.docx

PI 030-1 PIC/S 原料药检查备忘 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 030-1 13 January 2009 AIDE-MEMOIRE?备忘 INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS 原料药检查 ? ? PIC/S January 2009 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. ? ? TABLE OF CONTENTS目录??????????? 1. Document History?文件历史 2. Introduction?介绍 3. Purpose?目的 4. Scope?范围 5. Aide-Memoire?备忘 6. Revision History?修订历史 ? 1. DOCUMENT HISTORY?文件历史 Adoption by Committee 被委员会采用 12.11.2009 Entry into force of PI 030-1 实施 01.03.2009 ? 2. INTRODUCTION?介绍 2.1 The adoption of ICH Q7 as the first truly harmonised GMP guideline for active pharmaceutical ingredients (APIs) and the associated development of regulatory frameworks to implement the guideline as a regulatory standard mark the beginning of a new era of regulation for medicines. 采用ICH Q7作为真正意义上的原料药统一GMP指南，并伴随着法规框架的发展以实施指南作为法规的标准，标志着药品法规的一个新纪元。 ? 2.2 The adoption of ICH Q7 by PIC/S occurred in May 2001 with the current version of the guideline having been available since 1 September 2007 as GMP PE 009 (Part II). 2001年5月PIC/S采用了ICH Q7，现行版本指南GMP PE 009(第二部分)在2007年9月1日公布. ? 2.3 The primary objective for implementing ICH Q7 is the reduction of the risks associated with the manufacturing quality of APIs and this cannot be achieved without an effective inspection system which addresses the specific aspects of the global API industry. 实施ICH Q7的基本目标是减少原料药生产质量所伴随的风险，要达到这个目标，必须制订有效的检查体系，以说明全球原料药行业的各个独特方面。 ? 3. PURPOSE?目的 3.1 It is recognised that due to their background and experience the majority of GMP inspectors are more familiar with the inspection of finished products. 大家已认识到鉴于GMP检查人员的背景和经验，大部分检查人员对制剂检查更为熟悉。 Therefore, to assist inspectors not specialised in the inspection of API manufacturers this document has been developed to provide training and guidance for the preparation and performance of such inspections. 因此，为帮助非原料药生产商专