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GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems

Updated second edition aligns with recent regulatory and industry developments

Published: Thursday, February 17, 2011 - 09:14

(ISPE: Tampa, FL) --  The International Society for Pharmaceutical Engineering (ISPE), a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, released the GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition). This guide, which provides direction on achieving process control systems that are fit for intended use and meet current regulatory requirements, has been significantly updated to align with the concepts and terminology of recent regulatory and industry developments.

Developed by the GxP Process Control Systems Document Revision Task Team, and members of the ISPE GAMP Community of Practice (COP) Process Control Special Interest Group (SIG), the guide recognizes that ISPE’s Good Engineering Practice meets most of the applicable compliance requirements. The guide also emphasizes that in order to be efficient, appropriate specification and verification activities should be an integral part of the normal system life cycle. The guide recognizes that many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The guide promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost, and waste.

Concepts addressed by the new guide include:
• International Conference on Harmonization (ICH) Guidance setting out expectations for the application of science- and risk-based approaches to drug development and manufacture supported by pharmaceutical quality systems
• ISPE’s Product Quality Lifecycle Implementation (PQLI) global initiative for a practical approach to implementation of ICH Guidance for Industry documents: Q8(R2)—“Pharmaceutical development,” Q9—“Quality risk management,” and Q10—“Pharmaceutical quality system”
• The Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP) for the 21st Century Initiative
• Other emerging industry standards


The GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems will be available for purchase in book form and is already available as a downloadable PDF at www.ispe.org/GuideanceDocs/GAMP-GxP-Process-Control-Systems.


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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.