Transcription of Using the ISPE’s GAMP Methodology to Validate ...
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Using the ISPE’s GAMP Methodology to Validate ...
Using the ISPE sGAMP Methodology to Validate Environmental Monitoring System SoftwareTESTDOCUMENTSUSER REQUIREMENTSDETAILED SPECIFICATION DOCUMENTSFUNCTIONALSPECSB211370EN-A2 IntroductionContinuous Monitoring Systems (CMS) are used in the pharmaceutical industry to detect out-of-specification (OOS) conditions in manufacturing , processing and distribution environments. These modern, Web-based monitoring applications can also send email alarms to notify personnel to take corrective action before OOS conditions, such as extreme temperature or humidity, can have a negative effect on product quality and safety. Because a monitoring system can be considered an automated system we can manage this system Using the good automated manufacturing Practice ( gamp ) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). Specifically, let s consider the ISPE s publications: The gamp guide for Validation of automated Systems in Pharmaceutical Manufacture and gamp 5: A Risk-Based Approach to Compliant GxP Computerized Systems.
we can manage this system using the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). Specifically, let’s consider the ISPE’s publications: “The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture” and “GAMP 5: A Risk-Based ...
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