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ISPE has 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 recognises that good engineering practice meets most of the applicable compliance requirements.

The guide also emphasises that, in order to be efficient, appropriate specification and verification activities should be an integral part of the normal system lifecycle.

The guide recognises 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 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.

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