GAMP4(英).docVIP

Technical Document Review: 技术文件回顾： Good Automated Manufacturing Practice (GAMP) Guide for the Validation of Automated System 优化的自动化制造规范—自动化系统验证指导 Introduction 简介 This document aims to review the Good Automated Manufacturing Practice Guide for the Validation of Automated System (GAMP 4), December 2001, published by the ISPE. To learn more about GAMP or to place an order, visit The content of this summary hopes to identify the top level requirements of the steps undertaken to validate an automated manufacturing process, this includes environmental monitoring systems, autoclaves, filling lines, and any other process governed by electronic control rather than a manual process. 本文件旨在于对2001年12月由ISPE出版的GAMP4的回顾学习。若要更深入的了解GAMP或购买，请访问 HYPERLINK 网站，本概要希望能帮助用户充分理解在自动化系统验证过程中的高要求。这些系统包括 环境监测系统，高压灭菌填充线，除手动程序外其他任何受电子控制的的过程。 In the late eighties and early nineties the validation of automated system in pharmaceutical manufacturing assumed a much greater importance than had previously been the case. Although regulatory guidelines concerning the use of such automated systems had been available for some time, the systems had been subject to less regulatory scrutiny than other areas of production and were deemed to be less mature than more conventional areas. An industry group was set up to promote the understanding of the industry requirements. That group was made up of several major pharmaceutical manufacturers and become the GAMP Forum. In 2000, GAMP became formally affiliated with ISPE as a technical sub-committee within the organization. The guide has been broadened to incorporate a closer relationship with the ideals of system validation. The following sections identify the top-level features of the GAMP guide. 80年代后期90年代初，自动化系统验证在制药行业中已经显得越来越重要，尽管本指南对关于使用自动化系统有时是可行的，但由于缺乏详细审查（相对其他生产领域）有；因而相对其他传统领域来说，被认为是不成熟的。因此成立了一个产业集团推广人们对产业要求的理解，这个集团由几大主要的制药企业组成，并在2000年成立了GAMP论坛，随后GAMP正式附属ISPE这个组织中的一个技术委员会。本指南已做多次拓展以使之与自动化系统验证更紧密结合，以下是有关GAMP指南的发展情况： GAMP 1.0 →GAMP 2.0 → GAMP 3.0 →GAMP