Bioequivalence and Bioavailability Forum

Dear Auditor,

❝ My understanding is to perform at least three P&A, matrix effect and selectivity/ sensitivity on other (API) instrument to justify the conduction of study.

Agreed. Basically I would repeat the whole validation except stability experiments (and recovery, if you have it as part of your validation).

❝ Kindly suggest the correct practice and give if there is any reference on the above mentioned case.

No reference that I know of. The FDA guidance is extremely vague on partial validation (just says it can be anything from a single run for precision and accuracy to an almost full validation). But you should be able to justify scientifically what experiments need, and do not need, to be repeated. Matrix effects, selectivity and LLOQ do depend on the instrument you are using.

Regards
Ohlbe