The validation, the implementation and the transfer of analytical methods are strategic steps for the development, production, product release and monitoring of production processes. The validation or transfer of analytical procedures, required by the various regulations (ICH, EMA, FDA, PMDA…), provide proven track records on data reliability generated to characterize the batches produced and the manufacturing process, and guarantee that these procedures are fit for purpose. However, the recent USP <1220> and future ICHQ2(R2) and ICHQ14 texts raise the importance of the other stages in the life cycle of an analytical method: the acquisition of a thorough knowledge of the analytical procedure during development (including the study of robustness), a real control of the reliability of the results (including the notions of measurement uncertainty) and the monitoring of the analytical procedures after validation are key to guarantee the reliability of the results generated over time. This global management of the life cycle of an analytical method, with a focus on certain important steps and feedbacks, will be discussed during our next forum dedicated to analytical methods.
Venue to be announced Lausanne