Qualification/Validation: yesterday – today – tomorrow
The GMP-conform qualification is a requirement which has become mandatory for companies concerned with the introduction of GMP. GMP „Good Manufacturing Practice“, a three-word term, introduced in 1962 by the FDA (Food and Drug Administration) which stands as a synonym for a collection of rules of conduct and guidelines. Qualification, as an integral part of validation, has only been implemented in a correct and consistent manner since the early nineties. This article presents an overview of how qualification activities have changed in recent years and offers a preview of where the path may be leading to.