India Local Networking Group

FYI

Yes, for an Abbreviated New Drug Application (ANDA) submission, the batch that is used for stability studies and bioequivalence testing is typically expected to be manufactured in the same facility where the proposed commercial batch will be manufactured. This ensures that the batch used for testing is representative of the final product that will be marketed.

If both the ANDA submission batch and the proposed commercial batch are manufactured in the same facility, it is possible that both batches will be subject to inspection as part of a Pre-Approval Inspection (PAI). The purpose of the PAI is to assess the facility's compliance with current Good Manufacturing Practices (cGMP) and to ensure that the manufacturing process and the facility meet the necessary regulatory requirements.

During the PAI, the regulatory authorities may review the manufacturing processes, procedures, quality control systems, and documentation associated with the ANDA submission batch as well as the proposed commercial batch. The inspection aims to verify that the facility has the capability to consistently produce drug products that meet the required quality standards.

It's important to note that specific regulatory requirements may vary depending on the country and regulatory agency involved. Therefore, it is always recommended to consult the relevant guidelines and regulations applicable to your specific situation and jurisdiction.

Yes both of them require to follow all the regulations which are almost similar their is only the difference in clinical trials to conduct or not but in manufacturing all the rules are almost same.