Regulatory Open Forum

Hi, I am planning the CMC strategy for an NCE solid oral dose NDA. 

1. We want to have two DP manufacturing sites. The three registration batches had been made on site A. In order to add site B, do we need three registration batches from site B? In referencing post-approval change guidance, my thinking is that we need one batch from site B and demonstrate site B batch is highly similar to site A primary batches. Is there any specific guidance for the situation?
2. The registration batches were made without imprints on the capsules. How can we bridge the imprint requirements? Do I need to have the data from a batch with capsule imprints to go into the NDA? Or can the imprints be a commitment for the process validation batches? The lead time for imprinted capsules is frustratingly long. 

Thank you!

regarding Q1, 

Additional information regarding the dosage form, immediate release or controlled release is needed. If it is an immediate release solid oral dosage form, the stability of one batch with three months accelerated stability data reported in supplement; one batch on-long term stability data reported in annual report. Multi-point dissolution profile should be performed in the application medium . The dissolution profile of the drug product at the current and proposed site should be similar. The best approach is to file a CBE after approval and annual report for long-term stability data. Also, the proposed site should have no previous compliance issue. <o:p></o:p>

Reagarding Q2

The imprint in your registration batches should not be a concern but it should be reported to the Agency including the composition of the ink. You can discuss the imprint with FDA in a pre-NDA meeting. However, the validation batches should be manufactured with commercial formulation including the capsules.  <o:p></o:p>

Hi, I am planning the CMC strategy for an NCE solid oral dose NDA. 

1. We want to have two DP manufacturing sites. The three registration batches had been made on site A. In order to add site B, do we need three registration batches from site B? In referencing post-approval change guidance, my thinking is that we need one batch from site B and demonstrate site B batch is highly similar to site A primary batches. Is there any specific guidance for the situation?
2. The registration batches were made without imprints on the capsules. How can we bridge the imprint requirements? Do I need to have the data from a batch with capsule imprints to go into the NDA? Or can the imprints be a commitment for the process validation batches? The lead time for imprinted capsules is frustratingly long. 

Thank you!