iSpeak Blog

GAMP 25th Anniversary

Michael L. Rutherford
Guidance Docs

ISPE GAMP 25th Anniversary Logo

2016 marks 25 years of GAMP® and we are kicking off the celebration of this milestone with an event that is sure to get everyone talking. ISPE sends their congratulations to GAMP, on celebrating 25 years of helping the pharmaceutical industry achieve computerized systems that are fit for their intended use and meet current regulatory requirements.   For much of its 25-year history, GAMP has been affiliated with ISPE by becoming a technical subcommittee in 2000, and later a Communities of Practice (CoPs).  With GAMP’s involvement and commitment to ISPE, it is only fitting to kick off our global anniversary celebration at the 2016 ISPE Annual Meeting & Expo in Atlanta.

To commemorate this significant milestone, the GAMP 25th Anniversary Celebration Committee invites you to join us on Monday evening, 19 September, at Max Lager’s Wood-Fired Grill & Brewery - the oldest independent brewery restaurant in Atlanta known widely for its wood-fired cuisine and freshly brewed beers.  The registration fee includes food, beverages, entertainment, tastings, and tours of the brewery.  It is surely an event you will not want to miss, so sign up when you register for the 2016 ISPE Annual Meeting & Expo.  Space is limited! GAMP was initiated in 1991 by David Selby (founding chair) and Clive Tayler, with a core of experts in the United Kingdom, who realized the pharmaceutical industry needed to consider and meet evolving FDA and other regulatory agency expectations for computerized system compliance and validation as a result of a number of pivotal FDA inspections in the late 1980s and early 1990s.  The first product of the organization was a Draft Supplier Guide released to the membership on 1 March 1994, and published a year later.  As the expectations continued to evolve, so did the guide, with the publications of GAMP 2 in 1996, GAMP 3 in 1998, and GAMP 4, which broadened the scope to all GxP systems, in 2001.  By this time, GAMP quickly established itself as the definitive source of industry good practice for computerized system compliance and validation. 

Between 2001 and 2008, a number of Good Practice Guides (GPGs) applied, expanded, and clarified GAMP good practice to a wide variety of computerized systems.  The most current and significant version, GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems was released in February 2008, and showed how quality risk management could be fully integrated into the computerized system life cycle.  Since its release, many of the GPG’s have been revised to align with GAMP 5 and several new GPG’s have been created to address industry needs.  Today, GAMP good practices are used globally by regulated companies and their suppliers, and are widely supported by regulatory agencies (evidenced by the global regulatory input and being referenced in several regulatory guidance documents).