Hi,
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 .
http://www.askaboutvalidation.com/forum/showthread.php?1838-Campaign-Cleaning
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