Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are planning to file a new IND for a small molecule and part of the proposed plan for DP is to the have clinical pharmacies add the DP powder into the gel capsules before distributing to the patients.  My question is - how is this process described in the CTD or is it be more appropriate for the details to be in the Pharmacy Manual?  Of course, we will have all of the specific DP modules updated accordingly however, I am not sure if any information/details on the capsule filling needs to be in the CTD. 

This message was posted by a user wishing to remain anonymous

Manually??? New molecular entity? what about quantity allocated for stability? just hearing of this logistically comes across more of a potential cGMP issues!

Original Message:
Sent: 13-Sep-2023 11:34
From: Anonymous Member
Subject: Capsule filling with DP at clinical pharmacy? - Small molecule IND

This message was posted by a user wishing to remain anonymous

We are planning to file a new IND for a small molecule and part of the proposed plan for DP is to the have clinical pharmacies add the DP powder into the gel capsules before distributing to the patients.  My question is - how is this process described in the CTD or is it be more appropriate for the details to be in the Pharmacy Manual?  Of course, we will have all of the specific DP modules updated accordingly however, I am not sure if any information/details on the capsule filling needs to be in the CTD. 

You will need to describe in general terms how the DP is made in the IND (not as detailed as a pharmacy manual) plus information on testing, stability, etc. as mentioned by another response to this post. However, I will note that this is not unusual for early stage clinical trials. I am also a bit curious as to your comment on DP powder being added to capsules, as typically you would add just API in a capsule.

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Robert Blanks RAC
VP, Regulatory Affairs and Quality Assurance
[Ardelyx]
Auburndale MA
United States
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Original Message:
Sent: 13-Sep-2023 11:34
From: Anonymous Member
Subject: Capsule filling with DP at clinical pharmacy? - Small molecule IND

This message was posted by a user wishing to remain anonymous

We are planning to file a new IND for a small molecule and part of the proposed plan for DP is to the have clinical pharmacies add the DP powder into the gel capsules before distributing to the patients.  My question is - how is this process described in the CTD or is it be more appropriate for the details to be in the Pharmacy Manual?  Of course, we will have all of the specific DP modules updated accordingly however, I am not sure if any information/details on the capsule filling needs to be in the CTD. 

Some information and clarify may be missing from your question. You state that "clinical pharmacies" will be filling gel capsules with drug product powder and that specific CTD drug product modules are updated. I assume that means you are stating in Module 3 DP sections such information as to what the formulation of the drug product is and general description of the manufacturing equipment the pharmacies will use to fill the capsules. I also assume that a "batch record" of sorts will be generated by the pharmacies to provide assurance of the quality such, as fill weight, of the capsules. If those assumptions are correct, then a detailed description of the capsule filling procedure in a pharmacy manual will be sufficient and those details do not need to be in Module 3.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Burien WA
United States
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Original Message:
Sent: 13-Sep-2023 11:34
From: Anonymous Member
Subject: Capsule filling with DP at clinical pharmacy? - Small molecule IND

This message was posted by a user wishing to remain anonymous

We are planning to file a new IND for a small molecule and part of the proposed plan for DP is to the have clinical pharmacies add the DP powder into the gel capsules before distributing to the patients.  My question is - how is this process described in the CTD or is it be more appropriate for the details to be in the Pharmacy Manual?  Of course, we will have all of the specific DP modules updated accordingly however, I am not sure if any information/details on the capsule filling needs to be in the CTD.