Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?

No!

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GRSAOnline
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Original Message:
Sent: 13-Oct-2021 09:22
From: Anonymous Member
Subject: drug substance specification

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?

Just so I understand, this spec represents the quality of the API that you expect to receive from the supplier? But there are tests beyond what is registered as the drug substance spec in your NDA?

Agree with Narayan's very succinct feedback. I'm not sure under what circumstances FDA would see that (I'm not very familiar with the NCE side) but if they did, at most they might ask about it. Depending on the tests, they might wonder if there's some sort of issue that they should be aware of. But they won't just demand that those tests be added. And that's just speculation on my part.

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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 13-Oct-2021 09:22
From: Anonymous Member
Subject: drug substance specification

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?

Dear Anon,

Why do you want to add new tests with your API suppliers agreement that are not approved in NDA? Is it because the old approved tests are not no longer able to provide adequate controls of API quality from the suppliers? Something in process or raw materials is changed?

Really it depends.

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Gene Zhu
Principal Consultant
Pasadena, CA
USA
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Original Message:
Sent: 18-Oct-2021 08:22
From: Rachel Thornton
Subject: drug substance specification

Just so I understand, this spec represents the quality of the API that you expect to receive from the supplier? But there are tests beyond what is registered as the drug substance spec in your NDA?

Agree with Narayan's very succinct feedback. I'm not sure under what circumstances FDA would see that (I'm not very familiar with the NCE side) but if they did, at most they might ask about it. Depending on the tests, they might wonder if there's some sort of issue that they should be aware of. But they won't just demand that those tests be added. And that's just speculation on my part.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 13-Oct-2021 09:22
From: Anonymous Member
Subject: drug substance specification

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?

This message was posted by a user wishing to remain anonymous

(internal purchasing quality specs) "represents the quality of the API that you expect to receive from the supplier?"

The above scenario is very very typical and if not I would be surprised!!! The internal quality comprehensive specs are different from the approved NDA specs and it is nothing new! 
The original question did not say that they are adding new tests!!!
Original Message:
Sent: 13-Oct-2021 09:22
From: Anonymous Member
Subject: drug substance specification

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?

Yes, I understand that this is something sometimes a manufacturer like to do having two specs, a regulatory spec and an in-house spec. In that case, you can keep the two as is. However in your internal quality system you need to clearly establish a mechanism or decision tree to deal with cases where a lot passes reg spec but fails the in house spec, especially the failed test result is critical to control the quality.

Sent from my iPhone


Original Message:
Sent: 10/19/2021 12:37:00 PM
From: Anonymous Member
Subject: RE: drug substance specification

This message was posted by a user wishing to remain anonymous

(internal purchasing quality specs) "represents the quality of the API that you expect to receive from the supplier?"

The above scenario is very very typical and if not I would be surprised!!! The internal quality comprehensive specs are different from the approved NDA specs and it is nothing new! 
The original question did not say that they are adding new tests!!!
Original Message:
Sent: 13-Oct-2021 09:22
From: Anonymous Member
Subject: drug substance specification

This message was posted by a user wishing to remain anonymous

In supply agreements with our API manufacturers, we attach a purchasing spec.  If this spec includes additional test requirements beyond what's approved in our NDA, might FDA expect that the additional testing is included in our NDA?