GAMP Good Practice Guide Revision updates terminology, concepts.
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Press Release Summary:
GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) provides guidance on how to achieve process control systems fit for intended use and that meet current regulatory requirements. Aligned with recent regulatory and industry developments, guide recognizes that Good Engineering Practice meets most applicable compliance requirements. It also promotes leveraging of supplier documentation and activities to avoid duplication and waste.
Original Press Release:
ISPE Releases GAMP® Good Practice Guide: a Risk-Based Approach to GxP Process Control Systems, Second Edition
--Guide updated to align with recent regulatory and industry developments--
(TAMPA, FLORIDA, USA) - ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, today announced that it will release GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) on 18 February 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 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 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 US$145/ Euros115 for ISPE Members and US$405/ Euros345 for non-members. More information can be found at www.ISPE.org/GuideanceDocs/GAMP-GxP-Process-Control-Systems.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 22,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
