When deploying a new or upgraded pharmaceutical packaging solution, drug manufacturers and CMOs must conform to the regulatory requirements of the markets they serve. The regulatory agencies of the major markets of the world, as well as many other smaller markets, require adherence to Good Automated Manufacturing Practice (GAMP).
GAMP is a set of guidelines published by the International Society for Pharmaceutical Engineering(ISPE) for users and designers of automation systems in the pharmaceutical industry aimed at ensuring products have the required quality. Pharmaceutical serialization solutions are components of the larger pharmaceutical packaging automation system, so following GAMP guidance is essential.
In this paper, you will find information on how to:
- Enable rapid and consistent deployments
- Jump-start your GAMP 5 documentation needs
- Minimize risks, cost and downtime
- V-Model Lifecyle for GAMP 5