公用系统检查研究报告.docx

AIDE-MEMOIREINSPECTION OF UTILITIES备忘录公用系统检查TABLE OF CONTENTS目录1. Document History文件历史...........................................................................12. Introduction 介绍............................................................................................13. Purpose目的....................................................................................................14. Scope范围........................................................................................................15. Aide Memoire备忘录.......................................................................................26. Revision History修订历史...............................................................................91. DOCUMENT HISTORY 文件历史Adoption by Committee获委员会采纳24 April 2002Entry into force实施1 July 20022. INTRODUCTION介绍2.1Technological and technical progress have increased in the pharmaceutical industry in the last decades.Progress has not onlybeen made in the area of production equipment, technology and quality control but also in the area of auxiliary systems such as HVAC and media systems.2.1 近十年来，制药行业的技术和技术进步已经增加。进步不仅表现在生产设备、技术和质量控制方面，还在辅助系统如HVAC和介质系统等领域。2.2 PIC/S has paid due attention to these systems for the manufacture of medicinal products. In 2001, the annual PIC/S Seminar was devoted to the inspection of utilities used by the manufacturer of pharmaceuticals (Prague, Czech Republic).2.2 这些药品生产的这些系统已经引起的PIC/S关注。2001年，年度PIC/S研讨会致力于药品生产的公用系统的检查（布拉格，捷克共和国）。3. PURPOSE 目的3.1 The purpose of this document is to provide guidance for GMP inspectors to usefor training purposes and in preparation for inspections.3.1 该文件的目的是提供给GMP检查员用于培训目的和检查预期准备的指导。3.2 The Aide-Memoire is the direct result of the 2001 PIC/S Seminar and was drafted with the aim of facilitating the effective planning and conduct of GMP inspections of utilities.The Aide-Memoire should enable the inspector to make both an optimal use of the inspection time and an optimal evaluation of GMP compliance.3.2 该备忘是年度