I am performing cleaning validation in a small pharma company that manufactures a rather wide range of products.
During our first steps into cleaning validation, we were advised to seperate our sampling protocols (e.g. microbial, API, detergent) in order to minimize problems in case of possible failure. Validations written in this manner have already been audited here, without any criticism on this subject.
Since protocols have been seperated this has allowed us to choose (when applicable or deemed necessary) the exact same sampling sites for API and microbrial residue determination, in any given equipment.
My question is - given that the protocols are seperate and sometimes require sampling of the same exact site for different tests - would there be a reason to criticize a validation performed so as that the three validation runs done for API residue were after different batches than those that were sampled for detergent or microbial contamination?