The core purpose of the Good Automation Manufacturing Practice (GAMP) is to meet to meet the ‘fit for intended use’ regulations concerning computerized systems as well as other current regulatory requirements. The motto could be: ‘implementing the existing industrial good practice in the most efficient and effective way’.
Version four of the GAMP was roughly six years old. The new version five includes several significant updates integrating the necessary alignments within the latest concepts linked to the industrial developments and key regulations.
A focus on risk assessment, drug quality, data integrity and – above all – patient safety summarises the additions to the GAMP5. Clarifications are also welcome on some important points such as:
- Leverage supplier activities to the maximum possible extent
- Lifecycle activities and relevant documentation linked to complexity, risk and novelty
- Simplifying and avoiding the duplication of activities, responsibilities of users and suppliers
- Configuration packages and new classification of the categories of software (simplification)
Endress+Hauser participated at Copenhagen, Denmark on April the 7th and 8th, 2008 at the ISPE congress for launching the new GAMP5. The new guidelines, rules and recommendations will be integrated into our quality system.
Training sessions and re-certification are planned for our management, industry managers, development teams, sales engineers, service technicians, engineering, documentation / software developers, and quality departments. This training will be conducted worldwide.