With the publication of the aide memoire on the inspection of cleaning validation and verification in August 2023, the ZLG has published a very comprehensive guidance document. On around 50 pages, all aspects of the validation of cleaning processes are considered and the corresponding expectations of the supervisory authorities in Germany are formulated. With such a comprehensive revision (the previous document on validation/qualification comprised 52 pages, but covered all forms of validation and qualification), it is understandable that some "new" requirements or aspects have emerged that could lead to questions during implementation. For example, the question arises as to whether the formulation of "practical necessity" in connection with the creation of a cleaning validation master plan is to be understood as an implementation requirement or not. Especially as the AiM itself points out that this document is not required in Annex 15.
These and other points will be emphasized during the presentation. The aim is not to present a final statement on the individual points, but at best to provide a discussion and food for thought for the practical implementation of cleaning validation.