Dear Mr. Ankur
During introduction of new product (API) from R&D, is it acceptable to revise acceptance criteria of certain test parameters of intermediates (non-conformance) during trial batch (before creating validation protocol)?
Similarly cases like starting materials/raw materials of new product analyzed for trial batch and found to be non-conforming. Is it acceptable to evaluate and revise spec to accommodate the material.
What is the regulatory (quality assurance) evaluation of such cases against commercialized product. Is it justifiable? since it is a new molecule and changes (in spec/operation) were done only during trial batch.