The GAMP guidelines – from GAMP 1 to GAMP 5
The first draft of the GAMP (Good Automated Manufacturing Practice) guidelines was issued in February 1994 and distributed for review to British industrial firms. In January 1995, comments from 31 companies were incorporated into the second draft.
Version 1.0 of the GAMP guidelines was published in March 1995. It was based on the second draft, but included Annex 11 of the EU GMP guidelines. GAMP 1.0 was only available in electronic form.
In May 1996 a revised version of GAMP (version 2.0) was published and included further comments from Europe and the USA.
Version 3.0 of GAMP was issued in March 1998. It was divided into user and supplier guidelines and came in two volumes.
GAMP 4.0 appeared in December 2001 with comprehensive revisions and additions to ensure compliance with current regulatory and technical developments. It included a greater emphasis on the responsibilities of users and a more detailed description of the system operation activities.
Version 5 of GAMP was published by the ISPE in late 2007/early 2008. The fifth version of the guidelines is a response to the rapidly growing number of validated computer systems and their ongoing development in the pharmaceutical environment. The revised version also took into account changes in regulatory requirements.
For example, there was a greater focus on the risk-based approach, maintaining the validated state and the inclusion of all areas of GxP.
The existing GPGs (Good Practice Guides) are also under review, including the "Validation of Process Control Systems, Version 2" (available in 2008), and new GPGs are being created, such as "Validation of Small Manufacturing and Testing Devices" and "Electronic Data Archiving".
Arcondis AG has been following and implementing these approaches for several years. As a result, subjects such as the risk-based approach, maintaining the validated state and the validation of computer systems for manufacturers of medical devices do not represent a new challenge for Arcondis and its customers.