ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, will release GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) on February 18, 2011. The Guide, which provides guidance on how to achieve process control systems that are fit for intended use and meet current regulatory requirements, has been 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 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 the International Conference on Harmonisation (ICH) Guidance setting out expectations for the application of science- and risk-based approaches to drug development and manufacture supported by pharmaceutical quality systems and ISPE’s Product Quality Lifecycle Implementation (PQLI)global initiative for a practical approach to implementation of ICH guidances Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceutical Quality System. FDA cGMPs for the 21st Century Initiative and other emerging industry standards also were influences as the Guide was developed.

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. The cost of the document is $145 for ISPE Members and $405 for non-members.