GAMP 5 - Good Automated Manufacturing Practice
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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How the White Paper about GAMP 5 can help You
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:
- A brief history of GAMP
- The rationale for GAMP 5
- The driving forces behind GAMP 5
- A comparison of GAMP 5 and GAMP 4 -- specifically how they differ
- Tips on how companies can leverage GAMP 5 to their greatest benefit
Five Key Concepts of GAMP 5
The white paper also outlines and explains the five key concepts behind good automated manufacturing practice 5
- Product and Process Understanding
- Lifecycle approach within QMS
- Scalable Lifecycle Activities
- Science Based Quality Risk Management
- Leveraging Supplier Involvement
Other highlights of the GAMP 5 manual covered in the white paper include:
- Clarified roles
- Flexibility of format and structure
- Good automated manufacturing practice for suppliers expectations
- Supplier assessment and more
For More Information on Good Automated Manufacturing Practice - GAMP 5
For more information about GAMP 5, please feel free to contact a MasterControl representative.
The QMS Provider for the FDA
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.
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