A white paper for a good automated manufacturing practices available from MasterControl Inc. outlines the recently updated guidelines for GAMP 5, and provides information on how to use GAMP 5 to minimize validation efforts.
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The International Society for Pharmaceutical Engineering (ISPE) issued the worldwide release of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems in March of 2008. The updated manual for GAMP 5 provides guidelines for good automated manufacturing practices that are referenced in markets around the world, including North and South America, Europe, and Japan.
The white paper that you can download above offers GAMP 5 guidelines and offers ideas on how companies can utilize the processes and templates in the updated manual for GAMP 5 to minimize validation efforts and improve by good automated manufacturing practices.
A variety of subjects related to good automated manufacturing practice are covered in detail in the white paper, specifically:
The white paper also outlines and explains the five key concepts behind good automated manufacturing practice 5
Other highlights of the GAMP 5 manual covered in the white paper include:
For more information about GAMP 5, please feel free to contact a MasterControl representative.