Regulatory Open Forum

All,

Is there a minimum batch size for an approved product that is changing manufacturing sites?  An approved topical product is being transferred to my firm and we will be submitting a CBE-30 supplement.  Due to current equipment limitations our largest batch size is 57 kg.  In the guidance: Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, it states that the minimum batch size for topicals should be at least 100 kg or 10% of the commercial scale (whichever is greater).  The guidance is for original ANDAs, but does this minimum apply for post-approval supplements as well?  Will FDA refuse to receive this supplement because the batch size is too small? 

Thank you for your help/advice.

Nathan

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Nathan Johnston
Regulatory Affairs Senior Associate
Ei LLC
Kannapolis NC

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What is your planned commercial size? 57 Kg's? If you do a demonstration batch for stability at 57 Kg's and your proposed commercial batch size is 57 Kg's the agency will not refuse to review in this case. Now let's say you are going to install brand new equipment with the largest batch size being 2000 Kg's. If it were me, I would still do 57 Kg's submit my CBE-30 with commercial scale being 57 Kg's and once I have a new tank I would do the same CBE-30 with the much larger batch size.

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John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States

Original Message:
Sent: 01-04-2016 17:10
From: Nathan Johnston
Subject: Minimum batch size for topical

All,

Is there a minimum batch size for an approved product that is changing manufacturing sites?  An approved topical product is being transferred to my firm and we will be submitting a CBE-30 supplement.  Due to current equipment limitations our largest batch size is 57 kg.  In the guidance: Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, it states that the minimum batch size for topicals should be at least 100 kg or 10% of the commercial scale (whichever is greater).  The guidance is for original ANDAs, but does this minimum apply for post-approval supplements as well?  Will FDA refuse to receive this supplement because the batch size is too small? 

Thank you for your help/advice.

Nathan

------------------------------
Nathan Johnston
Regulatory Affairs Senior Associate
Ei LLC
Kannapolis NC

------------------------------

Thanks John,

Yes, the commercial scale will be 57 kg.  We are considering purchasing larger equipment in the future and will make another submission for that change. 

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Nathan Johnston
Regulatory Affairs Associate
Ei LLC
Kannapolis NC
United States

Original Message:
Sent: 01-05-2016 07:29
From: John Lay
Subject: Minimum batch size for topical

What is your planned commercial size? 57 Kg's? If you do a demonstration batch for stability at 57 Kg's and your proposed commercial batch size is 57 Kg's the agency will not refuse to review in this case. Now let's say you are going to install brand new equipment with the largest batch size being 2000 Kg's. If it were me, I would still do 57 Kg's submit my CBE-30 with commercial scale being 57 Kg's and once I have a new tank I would do the same CBE-30 with the much larger batch size.

------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States

Nathan,

Your risk is zero. Just do the 57Kg.

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John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States

Original Message:
Sent: 01-05-2016 08:38
From: Nathan Johnston
Subject: Minimum batch size for topical

Thanks John,

Yes, the commercial scale will be 57 kg.  We are considering purchasing larger equipment in the future and will make another submission for that change. 

------------------------------
Nathan Johnston
Regulatory Affairs Associate
Ei LLC
Kannapolis NC
United States