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.
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.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
