Changes in validation

There have been many changes to the approach to validation of equipment, including computerised systems over the last few years. This has culminated in the release of GAMP 5 in 2008.

The changes in approach started with the publication of the ICH Q9 (Quality Risk Management) in 2005 and adopted by the major agencies. This presented a risk based approach to quality management including validation of systems.

Another major change was the publication of the ASTM standard E2500-07 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) in 2007. This not only further detailed the approach to a risk based approach but changed terminology replacing qualification with verification.

The GAMP 5 Guide provided mechanisms (building of those from GAMP4) for a scalable risk based approach to validating systems and will welcome comments and discussions to share and improve best practices.

Through these posts I will be discussing approaches to validation of Computerised Systems, including risk based and scalable approaches. Putting the latest industry best practices and guidance in to practice.

This will include discussions on Good Engineering Practice (GEP) the foundation for design, installation and commissioning of equipment to meet both business and regulatory requirements.