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GAMP® 5:
Scaling of Quality Measures when using a Configurable Manufacturing Execution System


Article, pharmind 4/2009

Summary:

The GAMP® Guide provides a set of recognized principles and procedures for the validation of computerized systems in the pharmaceuticals industry. The last major revision - GAMP5 - was released in January 2008. In his article, Rolf Blumenthal, Senior Director International Consulting with Werum, points out how the guide now focuses on the scaleability of the validation procedures and methods to be applied. He outlines the scope and the scale of services a pharmaceutical company can expect from its system supplier today.

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Format: pdf
Filesize: 300 KB




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