If you’re in the business of Control and Automation, you’ve probably heard people talk about GAMP and know that it’s “some sort of quality thing for pharmaceuticals”. But what’s so special about GAMP®5, and why should you use it?
“GAMP®5” is a short-form for “The Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture Version 5”, a set of guidelines produced by the International Society for Pharmaceutical Engineering. The guide describes a set of principles and procedures to help ensure that pharmaceutical products have the required quality. Its current version is GAMP®5. Although the guidelines come from a pharmaceutical perspective, it is clear that its’ good practices can be equally well applied to other analogous industries, especially Food and Beverage.
GAMP®5 promotes a system lifecycle and risk-based approach, focusing on those computerised systems with most impact on patient (or consumer) safety, product quality, and data integrity. This means that quality must be built into each stage of the manufacturing process instead of relying on product batch testing. As a result, GAMP®5 covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.
GAMP®5 encourages all stakeholders in the product lifecycle to work collaboratively together to manage risk, instead of having the kind of them-and-us contractual relationship that is sometimes found in other industries. Computer system validation (CSV) following the GAMP®5 guidelines requires users and suppliers to work together so that responsibilities regarding the validation process are well understood. GAMP®5 provides a documented assurance for end users that a system is not only “working to spec” but is appropriate for the intended use and understood by all stakeholders.
In summary, GAMP®5 is not just a reworking of already-understood quality management tools, but instead combines proven good practices with a spirit of collaboration, shared responsibility and focussed risk management. It is pragmatic yet robust, giving confidence and certainty to users without placing unnecessary bureaucratic burdens on manufacturers.
As a supplier of control and automation services, Feed4ward Control Ltd is fully committed to GAMP®5, which forms the basis of all our work. We have a certified ISO9001 QMS that is aligned with and compliments our GAMP®5 procedures.
To discuss your GAMP®5 assured control and automation projects, please contact us at Feed4ward.