Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.

This message was posted by a user wishing to remain anonymous

In existence since the 90s, in several FDA therapeutic areas/divisions. This request is nothing new. It also means you will not be Refuse to file if you don't submit it in the initial filing but may be asked during review process.
Original Message:
Sent: 21-Jan-2019 19:06
From: Anonymous Member
Subject: Master Batch Records for NDA

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.

Not sure whether it is becoming a standard request, but I have been requested to submit a MBR for a biotech product in the past. I still would not submit it unless requested.

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 21-Jan-2019 19:06
From: Anonymous Member
Subject: Master Batch Records for NDA

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.

Though this is an NDA, I would take cue from the ANDA requirement for section 3.2.P.3.3. of  ANDA Submissions -
Content and Format Guidance for Industry, with requests "The master production batch record(s) for the largest intended production runs
(i.e., commercial batch records) that is/are no more than 10 times the exhibit
batch(es). "   https://www.fda.gov/downloads/drugs/guidances/ucm400630.pdf

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Constance Brown RAC
Manager, Regulatory Affairs CMC
Ambler PA
United States
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Original Message:
Sent: 21-Jan-2019 19:06
From: Anonymous Member
Subject: Master Batch Records for NDA

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.

I agree with Constance, that the anonymous response is applicable only to NDAs and not for ANDAs! OGD will refuse to receive if your Master production batch record is not included in the ANDA.

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GRSAOnline
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Original Message:
Sent: 23-Jan-2019 07:59
From: Constance Brown
Subject: Master Batch Records for NDA

Though this is an NDA, I would take cue from the ANDA requirement for section 3.2.P.3.3. of  ANDA Submissions -
Content and Format Guidance for Industry, with requests "The master production batch record(s) for the largest intended production runs
(i.e., commercial batch records) that is/are no more than 10 times the exhibit
batch(es). "   https://www.fda.gov/downloads/drugs/guidances/ucm400630.pdf

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Constance Brown RAC
Manager, Regulatory Affairs CMC
Ambler PA
United States

Original Message:
Sent: 21-Jan-2019 19:06
From: Anonymous Member
Subject: Master Batch Records for NDA

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.

FDA wants to know if the company is ready for commercial batch process.  
Usually PAI inspection may check for GMP readiness and get a feel for the company.  More recently, FDA wants to see the documentation along with inspection report. If FDA asks, you have to submit regardless.  You can change your MB later after PV is finished.
MB submission for now is for format and how the company handles the documentation process.

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Eugene Lee
60026 IL
United States
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Original Message:
Sent: 21-Jan-2019 19:06
From: Anonymous Member
Subject: Master Batch Records for NDA

This message was posted by a user wishing to remain anonymous

I have been recently asked to submit a drug product Master Batch Record (MBR) for a NDA under review. An executed drug product batch record was submitted in the initial submission. I have previously never been asked for a blank MBR. Is this request unusual or is now becoming a standard request from FDA?

Thank you.