Gamp 5 addresses the entire lifecycle of computerised systems, with principles applicable to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructure
ISPE, a global not-for-profit association of 25,000 pharmaceutical manufacturing professionals, has issued the global launch of Gamp 5: A risk-based approach to compliant GXP computerised systems, its latest industry-impacting technical publication.
The document is the fifth revision of the original document published in 1994.
"Gamp 5 is a major revision of the last version released in 2001 and is aimed at enabling innovation and pragmatic, cost-effective compliance," said Sion Wyn, editor of the guide, and member of the ISPE Gamp Community of Practice Council.
"It describes a common-sense approach based on current good practice".
The document was developed by users within the field, according to Wyn.
"We have an established community of expert practitioners from all over the world who have been working in this area for many years.
"It has the strength of the community behind it".
This technical document provides pragmatic and practical industry guidance that aims to achieve compliant computerised systems that are fit for intended use in an efficient and effective manner while also enabling innovation and technological advance.
This document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification.
A robust quality risk management process based on ICH Q9 principles is central to the approach.
Gamp 5 also contains new information on topics including outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
As with all ISPE technical documents, the document utilises a practical, pragmatic, non-theoretical approach, giving the reader guidance on solving problems, and is a valuable tool when it comes to regulatory inspections, directly assisting in compliance issues.
Gamp 5 was introduced at ISPE's conference on manufacturing excellence, 25-28 February 2008 in Tampa, Florida, USA.
A complimentary copy of Gamp 5 was provided to conference delegates attending the session, Gamp 5: Enabling Innovation and Technological Advance.
The European launch of Gamp 5 will take place at ISPE's Congress on Innovation in Copenhagen, Denmark, April 2008.
