There has also been a major move toward the use of products and packaged solutions and away from bespoke developments.
As a result the GAMP Council is planning to revise the GAMP Guide to reflect current regulatory expectations and current industry good practice while maintaining continuity with GAMP 4 principles. The Guide will be focus on the use of products and packaged solutions rather than custom (bespoke) systems.
The emphasis will be on providing a cost effective approach to validation that will demonstrate that a computerized system is fit for its intended use, while avoiding unnecessary work. To support this, new and updated guidance is in development on the following aspects:
- Scaleable validation approach driven by risk to product quality, patient safety and regulatory compliance including supporting records.
- Integration of validation activities within a complete life cycle approach as part of a Quality Management System (QMS), from concept through development and operation to retirement.
- Use of supplier documentation and knowledge wherever possible to avoid repetition and duplication.
- Importance of clear requirements based on a thorough understanding of the process and product.
- Improving validation efficiency by enabling practical and efficient interpretation of GAMP guidance
Concepts and terminology will be aligned with recent regulatory developments including:
- FDA cGMPs for the 21st Century Initiative and associated guidance.
- PIC/S Guidance.
- ICH (International Council for Harmonization) Guidance Q9 and Q10.
- Emerging standards such as those produced by the ASTM E55 Committee
Source : ISPE, GAMP COP.