Regulatory Open Forum

We are planning for manufacture of API Registration batches for our IR tablet product. We currently have single suppliers for our 3 Regulatory Starting Materials (RSMs), but would like the flexibility to use other RSM suppliers in the future (ex. Process Validation or commercial). My understanding is that it is acceptable to switch suppliers as long as the RSM specification is met. Therefore my plan is to NOT list the suppliers in the NDA and only provide specifications for each RSM. This would allow using a different RSM supplier for process validation or commercial and would not require any regulatory action (ex. amending a pending NDA or a sNDA to an approved NDA. Is this approach sound acceptable? 

Thank you.

Whether you list suppliers or not the COA for RSM you would probably include in your NDA? Right? 

We are planning for manufacture of API Registration batches for our IR tablet product. We currently have single suppliers for our 3 Regulatory Starting Materials (RSMs), but would like the flexibility to use other RSM suppliers in the future (ex. Process Validation or commercial). My understanding is that it is acceptable to switch suppliers as long as the RSM specification is met. Therefore my plan is to NOT list the suppliers in the NDA and only provide specifications for each RSM. This would allow using a different RSM supplier for process validation or commercial and would not require any regulatory action (ex. amending a pending NDA or a sNDA to an approved NDA. Is this approach sound acceptable? 

Thank you.

Hi Tom,

I don't think it will work like that. Because the starting material is regulated as GMP materials, the manufacturer should be listed or referenced (if a DMF exists) in the dossier. The manufacturer is subject to pre-license or pre-approval inspection and any change to the manufacturer should be reported in a post approval supplement or an IND amendment if it is in clinical development phases.

Whether you list suppliers or not the COA for RSM you would probably include in your NDA? Right? 

We are planning for manufacture of API Registration batches for our IR tablet product. We currently have single suppliers for our 3 Regulatory Starting Materials (RSMs), but would like the flexibility to use other RSM suppliers in the future (ex. Process Validation or commercial). My understanding is that it is acceptable to switch suppliers as long as the RSM specification is met. Therefore my plan is to NOT list the suppliers in the NDA and only provide specifications for each RSM. This would allow using a different RSM supplier for process validation or commercial and would not require any regulatory action (ex. amending a pending NDA or a sNDA to an approved NDA. Is this approach sound acceptable? 

Thank you.