Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi Colleagues,

I would like to ask which filing category would this change fall:

Our company was informed by the drug substance manufacturing sites that there is a change in supplier of the starting material used in the manufacture of one of our product X. The information on starting material suppliers and control of starting material are included in the restricted part of DMF, the DMF folder filed the updated DMF to FDA. For the drug product manufacturer, would this change be filed as CBE 30 or including in an annual report sufficient? Comparative batch analysis data on DP lots from new vendors and stability has been initiated for validation batches, no significant trend is observed.

Thanks in advance for any feedback.

This message was posted by a user wishing to remain anonymous

​Change to a new supplier of starting material would be considered a change to the process of drug substance so CBE-30 is likely suggestion for to consider. If the use of this starting material produces a new impurity profile of the final drug substance then PAS.
Original Message:
Sent: 28-Nov-2017 09:39
From: Anonymous Member
Subject: NDA Post approval change

This message was posted by a user wishing to remain anonymous

​Hi Colleagues,

I would like to ask which filing category would this change fall:

Our company was informed by the drug substance manufacturing sites that there is a change in supplier of the starting material used in the manufacture of one of our product X. The information on starting material suppliers and control of starting material are included in the restricted part of DMF, the DMF folder filed the updated DMF to FDA. For the drug product manufacturer, would this change be filed as CBE 30 or including in an annual report sufficient? Comparative batch analysis data on DP lots from new vendors and stability has been initiated for validation batches, no significant trend is observed.

Thanks in advance for any feedback.

This message was posted by a user wishing to remain anonymous

​Thank you for your feedback.
Original Message:
Sent: 28-Nov-2017 15:43
From: Anonymous Member
Subject: NDA Post approval change

This message was posted by a user wishing to remain anonymous

​Change to a new supplier of starting material would be considered a change to the process of drug substance so CBE-30 is likely suggestion for to consider. If the use of this starting material produces a new impurity profile of the final drug substance then PAS.
Original Message:
Sent: 28-Nov-2017 09:39
From: Anonymous Member
Subject: NDA Post approval change

This message was posted by a user wishing to remain anonymous

​Hi Colleagues,

I would like to ask which filing category would this change fall:

Our company was informed by the drug substance manufacturing sites that there is a change in supplier of the starting material used in the manufacture of one of our product X. The information on starting material suppliers and control of starting material are included in the restricted part of DMF, the DMF folder filed the updated DMF to FDA. For the drug product manufacturer, would this change be filed as CBE 30 or including in an annual report sufficient? Comparative batch analysis data on DP lots from new vendors and stability has been initiated for validation batches, no significant trend is observed.

Thanks in advance for any feedback.