Certainly the answer from the CBER side is yes. Process validation must be completed before distribution of the final drug. Moreover, not only would the validation be complete, but also the validation data would be reviewed as part of the filing. In CDER, the validation information doesn’t necessarily get submitted as part of the NDA, but that is something that would get reviewed by the field inspection, and then the field would say that the process is validated and would recommend or not recommend approval based on their inspection.
The only time validation for CDER products would be expected in the filing is with sterile products, sterile processes, and sterilization processes, that type of data would be submitted in the filing. Generally, CDER does not expect a completion of validation for purposes of a preapproval inspection. CDER like to see is at least one validation batch completed at the time of the PAI so that the field investigator can see technology transfer. But completion of validation is not an expectation for purposes of the PAI or approval of an application.
