Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

My understanding is that you are encouraged to use multiple lots in the 3 batches submitted for stability. I don't think there will be anything wrong regulatory-wise with your approach; however, I think it will make the analysis of your own data difficult, especially if there was unplanned variance. The FDA can be inconsistent in its interpretations of lots vs batches, so be sure to be sure to explain how your product batches were formed.



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Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
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Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

You come up with the question because you are considering first-in, first-out approach that many people faces based on quality assurance perspective. You can justify the partial quantity of the current lot and reason for the submission batch that requires unique API lot for submission.

The objective for 3 submission batches using 2 different lot of API is to prove reproducibility of the manufacturing processes and to prove there is no lot by lot variation in the API that affect the drug product.

Technically there is nothing wrong to mix two API in single batch, but for submission purposes, each individual batch with single lot of the API is advisable to keep the identity of the API for specific batch. In the R&D report you can conclude that your all three submission batches drug product has been prepared using two or more API and there is no significant variation in the critical quality attributes.

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Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you all for the insights. This is very helpful.
Original Message:
Sent: 16-May-2017 22:33
From: Gaurang Bhavsar
Subject: Number of API lots in one submission batch

You come up with the question because you are considering first-in, first-out approach that many people faces based on quality assurance perspective. You can justify the partial quantity of the current lot and reason for the submission batch that requires unique API lot for submission.

The objective for 3 submission batches using 2 different lot of API is to prove reproducibility of the manufacturing processes and to prove there is no lot by lot variation in the API that affect the drug product.

Technically there is nothing wrong to mix two API in single batch, but for submission purposes, each individual batch with single lot of the API is advisable to keep the identity of the API for specific batch. In the R&D report you can conclude that your all three submission batches drug product has been prepared using two or more API and there is no significant variation in the critical quality attributes.

------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

During presentations I have attended, OPQ has provided the above direction. So, two discrete lots in batch 1 and 2. For batch 3, the lots can be mixed or a third lot. Also, this applies for each strength of your drug product.
Cindy

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Cynthia Katsempris
Director, Regulatory Affairs
Three Bridges NJ
United States
------------------------------

Original Message:
Sent: 17-May-2017 10:27
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Thank you all for the insights. This is very helpful.
Original Message:
Sent: 16-May-2017 22:33
From: Gaurang Bhavsar
Subject: Number of API lots in one submission batch

You come up with the question because you are considering first-in, first-out approach that many people faces based on quality assurance perspective. You can justify the partial quantity of the current lot and reason for the submission batch that requires unique API lot for submission.

The objective for 3 submission batches using 2 different lot of API is to prove reproducibility of the manufacturing processes and to prove there is no lot by lot variation in the API that affect the drug product.

Technically there is nothing wrong to mix two API in single batch, but for submission purposes, each individual batch with single lot of the API is advisable to keep the identity of the API for specific batch. In the R&D report you can conclude that your all three submission batches drug product has been prepared using two or more API and there is no significant variation in the critical quality attributes.

------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

I agree with Cindy.  I have successfully filed ANDAs with one of the 3 exhibit batches having a mix of 2 API lots. As long as you have 2 product batches each made with separate, distinct API lots.  You are allowed flexibility on that 3rd batch.

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Lisa Apolis
Regulatory Consultant
Dublin CA
United States
------------------------------

Original Message:
Sent: 18-May-2017 08:24
From: Cynthia Katsempris
Subject: Number of API lots in one submission batch


During presentations I have attended, OPQ has provided the above direction. So, two discrete lots in batch 1 and 2. For batch 3, the lots can be mixed or a third lot. Also, this applies for each strength of your drug product.
Cindy

------------------------------
Cynthia Katsempris
Director, Regulatory Affairs
Three Bridges NJ
United States
------------------------------

Original Message:
Sent: 17-May-2017 10:27
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Thank you all for the insights. This is very helpful.
Original Message:
Sent: 16-May-2017 22:33
From: Gaurang Bhavsar
Subject: Number of API lots in one submission batch

You come up with the question because you are considering first-in, first-out approach that many people faces based on quality assurance perspective. You can justify the partial quantity of the current lot and reason for the submission batch that requires unique API lot for submission.

The objective for 3 submission batches using 2 different lot of API is to prove reproducibility of the manufacturing processes and to prove there is no lot by lot variation in the API that affect the drug product.

Technically there is nothing wrong to mix two API in single batch, but for submission purposes, each individual batch with single lot of the API is advisable to keep the identity of the API for specific batch. In the R&D report you can conclude that your all three submission batches drug product has been prepared using two or more API and there is no significant variation in the critical quality attributes.

------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------

Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!

Hi,

As others have mentioned, a minimum of two lots of the DS should be used to prepare the three primary batches of DP. 

For nasal aerosols and nasal sprays, you should use three different lot of DS.

Best Regards,

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Tyng-Yi (Tina) Lee MS RAC
Consultant
North Brunswick NJ
United States of America
------------------------------

Original Message:
Sent: 16-May-2017 08:38
From: Anonymous Member
Subject: Number of API lots in one submission batch

This message was posted by a user wishing to remain anonymous

Good morning,

I have a question regarding ANDA submission batch. Can we use two API lots in the same batch (one batch) that will be used as part of the submission batches for an ANDA submission?

Thank you!