This is regarding Analytical method validation (AMV) and cleaning method validation (CMV) of API.
We perform AMV/CMV at R&D and provide the package to QA for production activities.
The AMV/CMV is adopted by QA following method transfer activity.
The question is,
(i) Performing AMV/CMV at R&D is correct or should it be performed at production.
(ii) By transferring AMV/CMV package from R&D, will it be subjected to regulatory audit?
(iii) I was told that, since method transfer is adopted by QA, it only will be responsible for responding any query during audit and R&D will not be included. Is it right?
(iv) What is the best practice.