Focus attention on computerized systems that most impact patient safety, product quality, and data integrity.GAMP also designed GAMP 5 to be compatible with IEEE standards, ISO 907, IT Infrastructure Library (ITIL), and other international standards. PIC/S Guidance Practice for Computerized Systems in Regulated GxP Environments which clarify regulatory expectations.ICH Guidance Q8, Q9, and soon to be released Q10, which is expected to promote science based risk management.FDA cGMPs for the 21st Century initiative and associated guidance promoting science-based risk management.Why GAMP 5 Now? Since the release of GAMP 4 in 2001 the regulatory bodies had made significant updates in their thinking and approach to regulatory compliance. The GAMP guidances are accepted by regulators world wide and referenced by the FDA and PIC/S in their documents. Today GAMP is a global organization which has “communities of practice” (COP) in Europe, Japan, and the Americas. GAMP 4, which was released in 2001, has been one of the standards GxP companies have been using for computerized system validation for the last seven years. They joined forces with ISPE (International Society for Pharmaceutical Engineering) as a “technical sub-committee” and in 1995 released the first GAMP guidelines. The purpose of the guidelines is to “provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.” 1 GAMP History GAMP (Good Automated Manufacturing Practice) was started in 1991 by a group of pharmaceutical experts in the UK who wanted to meet the changing FDA expectations for GMP compliance of manufacturing and related systems.

These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. White Paper The new GAMP®5 guidelines were released February 2008 at the ISPE Manufacturing Excellence Conference in Tampa, Florida. White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

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