Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello there,

Our company would like to change testing laboratory for a specific test on our API and finished product. We cannot find a mention of the current lab in our paper based original NDA. If the name of the current laboratory hasnt been mentioned before and not in FDA records, is it acceptable to change laboratory internally as long as it also meets same GMP standards?

Or does anyone know if its possible to find out from FDA if indeed there is a specific lab associated with our NDA and API/finished product testing?

Thank you in advance!

At minimum, I would suggest you add the new lab as an alternate testing lab via a CBE-30 according to the PAC-ATLS guidance.  That way at least you have the site that you'll be using filed to the NDA.

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Tom
Chicago
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Original Message:
Sent: 24-Jul-2018 09:05
From: Anonymous Member
Subject: Changing testing laboratories and notifying FDA

This message was posted by a user wishing to remain anonymous

​Hello there,

Our company would like to change testing laboratory for a specific test on our API and finished product. We cannot find a mention of the current lab in our paper based original NDA. If the name of the current laboratory hasnt been mentioned before and not in FDA records, is it acceptable to change laboratory internally as long as it also meets same GMP standards?

Or does anyone know if its possible to find out from FDA if indeed there is a specific lab associated with our NDA and API/finished product testing?

Thank you in advance!

​I agree with Tom. The current expectation is that all QC testing labs should be registered in your NDA. Even if it somehow got through back when the product was originally registered, FDA would certainly expect to be notified of a change in testing lab now.

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

Original Message:
Sent: 24-Jul-2018 09:05
From: Anonymous Member
Subject: Changing testing laboratories and notifying FDA

This message was posted by a user wishing to remain anonymous

​Hello there,

Our company would like to change testing laboratory for a specific test on our API and finished product. We cannot find a mention of the current lab in our paper based original NDA. If the name of the current laboratory hasnt been mentioned before and not in FDA records, is it acceptable to change laboratory internally as long as it also meets same GMP standards?

Or does anyone know if its possible to find out from FDA if indeed there is a specific lab associated with our NDA and API/finished product testing?

Thank you in advance!