Qualifizierung und Validierung bei der Herstellung pharmazeutischer Wirkstoffe und Zubereitungen
Concept Heidelberg GmbH, Heidelberg
Qualification and Validation in the Manufacture of Active Pharmaceutical Ingredients and Pharmaceutical Products Manufacturing processes of pharmaceutical products and their starting materials have to lead reproducably to qualitative unobjectionable products. This will be proved by the validation of the process. For a complete validation it is necessary that the whole equipment works properly and that the environment is suitable. This means: all quality-relevant measuring equipment and control devices have to be calibrated; premises, equipment, and utilities have to be qualified; computer and cleaning processes as well as analytical methods have to be validated. This review discusses the actual requirements and their application to the validation of pharmaceutical products and active pharmaceutical ingredients (APIs). Hints for the transfer of the requirements into practice and for the generation of a compliant documentation will be given from the design phase to the maintainance of the validated status during routine production.
Key words Arzneimittel Â· AusrÃ¼stung Â· Herstellungsverfahren Â· Qualifizierung Â· Validierung Â· Wirkstoffe