When developing a new product in-house and introducing it to a CMO, when is the Product development report (PDR) typically approved? Would it be prior to building engineering batches at the CMO? Is it considered good practice to leave it in draft until just before submission of the regulatory filing?
No one commnet on PDR/exhibit batch report/ eng batch/etc , its your organization ducumentry. However, in many ogranization -PDR not a filling documentay. If formulation scaling is complex one w.r.t. executaion, post execuation analytical profile, etc , you must proceed eng batch for getting conifidence before EB batch.