Hi Mahul.
I would likely agree with John on this point. I would think that in order to get the maximum information out of the program itself to defend the ability to utilize either supplier of either API in any particular batch, you will need to have data showing that the APIs from every supplier create a product that can meet its specifications throughout the shelf-life of the product regardless of which supplier combinations might be used. So you would need to do:
A-A
A-B
B-A
B-B
That said, another wrinkle in the process might become knowing whether use of separate batches from each supplier could have different impact on the product stability and safety and efficacy profiles. So you need to consider how to justify that point as well. My suggestion would be to do a fifth batch using independent batches of API from 1 supplier each. That would at least give you some information about the potential for impact due to inter-batch variability in the APIs used. Now, the fun point. how would you handle having to "blend" the "same" API from different manufacturers? As I see it there could arise a situation where you have enough of an API from one supplier to make 60-70% of your standard production scale batch. Your next delivery came from your other supplier and that is what would be expected to be used under First-in-first-out methodologies. But, without information on how this might impact efficacy, safety or stability, you are really just hoping to get the product through unless you do the work upfront to know it. So while there are always business reasons for having multiple suppliers of materials, just remember the more suppliers you have the more work you are going to need to do...
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States
Original Message:
Sent: 03-11-2016 07:36
From: John Lay
Subject: Submission batches for ANDA
You're going to have a lot of stability. You will have to match each supplier with each supplier. In your case you will have no less than 4 stability programs that matches each supplier.
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John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States