-国际辅料协会美国部针对辅料供应商的GMP审计指导原则(中文翻译稿).pdfVIP

Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 The Joint IPEC–PQG Good Manufacturing Practices Audit Guide For Pharmaceutical Excipients IPEC-PQG 药用辅料 生产质量管理的审计指南 第 1 页 / 共 52 页 , Soltoris Management Consultants, Inc. info@ Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 ACKNOWLEDGEMENTS 鸣谢 This Guide was prepared by a team from the International Pharmaceutical Ex cipients Council (IPEC) and the Charted Quality Institute (CQI) Pharmaceutical Quality Group (PQG). 该指南由国际药用辅料协会（IPEC）和特许质量协会（CQI ）的药品质量小组（PQG）共同制定。 IPEC 国际药用辅料协会 IPEC is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising three regional pharmaceutical excipient industry associations covering the United States, Europe and Japan (which are known respectively as IPEC-Americas, IPEC Europe and JPEC). IPEC’s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace and the development of go od manufacturing practices for excipients. IPEC 是辅料生产商和最终用户于1991 年创建的国际行业协会。这个协会包含了美国、欧盟和日本三个地区的 药用辅料行业组织 （上述三个组织通常简称为IPEC-美国、IPEC-欧盟和PEC）。IPEC 的目标是促进、协调国际 辅料标准和辅料生产质量管理规范的发展，并将有用的新辅料推向市场。 IPEC first published its GMP Audit Guide for Bulk Pharmaceutical Excipients in 1995 and it was revised in 2004 to align it with the revised 2001 GMP guide. IPEC 于1995 年首次颁布了散装药用辅料的GMP 审计指南，为了符合2001 年的GMP 指南，2004 年又对该指 南做了修订。 For further information see 更多信息请登录以下网站查询： PQG 药品质量小组 The PQG was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and