gamp自动化系统验证指南.pdf

Technical Document Review: Good Automated Manufacturing Practice (GAMP) Guide for the Validation of Automated System Introduction 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. 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. GAMP 1.0 GAMP 2.0 GAMP 3.0 GAMP 4.0 Mar 1995 Mar 1996 Mar 1998 Mar 2001 Original document Revision following Revision includes Broadened scope in created by comments comments from Supplier and User line with regulatory of 31 companies, Europe and USA sections requirements and new originally UK