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Reinigungsvalidierung in der Herstellung fester Arzneiformen

Claudia Grzeszik und Rolf Piepho

NextPharma GmbH, Standort Göttingen (Deutschland)^*)

During production of medicinal products product quality can be affected by carry-over of product residues. To ensure product quality cleaning procedures must be applied, that remove these residues in a reliable and reproducible manner. Cleaning validation is documented evidence, that a cleaning process suits this purpose. With regard to the product portfolio and the equipment the extent of validation has to be defined, as well as acceptance criteria, and appropriate sampling techniques and analysis methods have to be established. Moreover, in the planning process of the cleaning validation it has to be taken into account, that adequate ressources are available. The following article ought to give an overview of the basic approach to plan and perform a cleaning validation in the production of solid dosage forms.