6.1.1. The state of quality

Prior to QbD the traditional state of quality in the pharmaceutical environment refers to regulated areas of development and production, which are required to comply with current GMP guidelines and are under strict oversight of QA and the responsibility of the qualified person. These areas cover all activities connected to the manufacturing, testing or release of medication either for clinical studies or the commercial market, including stability testing, analytical method validation, equipment qualification, cleaning validation, process validation, investigations of out of specification results, audits of suppliers and contract manufacturers, and the risk assessment of all quality related aspects.

On the other hand, all development activities of pharmaceutical development and analytical development are not subject to QA oversight and are mostly completed with little or no interaction with the QA unit.

As a result the quality of development activities in the project and for the drug compound or drug product are carried out according to the scientific expertise and experience in the project teams and separate functional units. Not having to comply with CGMP requirements for most of these activities is usually considered to be an advantage as the high regulation and need for documentation and control for CGMP activities is often slowing down progress in the development.

On the other side the lack of oversight and internal guidance in both the projects and scientific activities often causes severe problems in the overall and also the scientific quality, which are revealed often rather late causing significant damage to the success of this project or product. Especially when working with external partners or contract manufacturers such problems are observed frequently and are seen to result in significant delays and unplanned costs.