公用系统检查

AIDE-MEMOIRE

INSPECTION OF UTILITIES

备忘录

公用系统检查

TABLE OF CONTENTS

目录

1. Document History文件历史 (1)

2. Introduction 介绍 (1)

3. Purpose目的 (1)

4. Scope范围 (1)

5. Aide Memoire备忘录 (2)

6. Revision History修订历史 (9)

1. DOCUMENT HISTORY 文件历史

2. 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 HV AC 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HV AC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PIC/S研讨会的直接结果，并以促进公用系统的GMP检查有效规划和管理为目的起草的。该备忘应能够使检查员既能完成检查时间的优化使用，又能得到GMP符合性的最佳评价。

4. SCOPE 范围

4.1 The following Aide-Memoire describes different areas which could be evaluated during the GMP inspection of HV AC systems, pharmaceutical water, steam and medicinal gases. However, the Aide-Memoire should be considered as

anon-exhaustive list of areas to be looked at during an inspection.

4.1 接下来的备忘描述了在对HV A V系统、制药用水、蒸汽和药用气体进行GMP 检查期间可以进行评估的不同区域。但是，该备忘只能作为一个未全尽的清单来使用。

4.2 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation orthe pursuit of excellence. The advice in this Aide-Memoire is not mandatory for industry. However, industry should consider PIC/S recommendations and aide-memoires as appropriate.

4.2 在签发本文件时，该文件反映当前的理想状态。本文件无意阻碍技术革新或追求卓越。该备忘中的建议对制药行业来说并不是必须实施的。但是，制药行业应在适当时考虑PIC/S和备忘的建议。

5. AIDE MEMOIRE备忘