Equipements and facilities Holding time study

To stop the number of batches of campaign to manifucter, the study must be carried out on the worst case product of the cleaning validation? or should we define a microbiological worst case but this time on what basis?
Tahnks in advance.

logically both and more should be considered , see the following links

http://ec.europa.eu/health/files/gmp/2014-02_pc_draft_gmp_annex.pdf .


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