Good Automated Manufacturing Practice - How is Good Automated Manufacturing Practice abbreviated?
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References in periodicals archive
GAMP 5 Good Automated Manufacturing Practice
(GAMP) Guide for A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, ISBN 1-931879-61-3, www.
Version 5 of Good Automated Manufacturing Practice
(GAMP) Released to Public
The Good Automated Manufacturing Practice
(GAMP) Guide for Validation of Automated Systems--its supplier audit section in particular (1)--is widely used as a starting point for identifying the right vendors.
During the early 1990's the pharmaceutical industry had recognized the need to improve the understanding of the use of automated systems, not just with regard to the regulations, but also to aid suppliers and define how such systems should be introduced In the UK a Forum was set up, resulting in the Good Automated Manufacturing Practice
(GAMP) Guide for validation of automated systems in pharmaceutical manufacture being produced.
The Baseline Guide and Good Automated Manufacturing Practices
document published by the International Society for Pharmaceutical Engineering provides an excellent foundation upon which to base risk assessment.
The development and documentation of BI-PSD21 was based on the life cycle approach found in the Good Automated Manufacturing Practices