Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work for a pharmaceutical company and we perform full testing of our excipients.  We are now implementing a reduced testing program where we will accept vendor COA results based on qualification of each vendor/excipient.  My question is, do we need to revise our filed excipient specification and notify FDA of this change in a supplement?  Is this just an internal change that would be reviewed during an inspection?  Thanks for your input.

Dear anonymous,

Without knowing more about your product and what was filled in your application, I would advise you to consider the number of guidance documents on CMC post approval changes and to ensure your SOPs on supplier management and vendor qualification include the specifics around reduced testing and acceptance of vendor CofA results.  Acceptance of vendor results should be based on the consistency of results, not necessarily qualification of each vendor/excipient, number of excipient lots, evaluation of OOS, OOT and other criteria set forth in you SOPs, number of deviations or CAPAs, etc.  

The notification pathway to FDA will depend on what was filed in your application and could fall under the annual report submission but again, hard to be definitive without knowing specifics.  I would also advise that a risk assessment is conducted to ensure that product quality is not at risk and that you have clearly defined your critical excipients (key to product quality) and evaluated them appropriately.  I would also advise that you incorporate a metric for effectiveness once you implement any reduced testing. 

Good luck,

Dar


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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 16-Aug-2021 16:15
From: Anonymous Member
Subject: Regulatory Impact for Reduced Testing

This message was posted by a user wishing to remain anonymous

I work for a pharmaceutical company and we perform full testing of our excipients.  We are now implementing a reduced testing program where we will accept vendor COA results based on qualification of each vendor/excipient.  My question is, do we need to revise our filed excipient specification and notify FDA of this change in a supplement?  Is this just an internal change that would be reviewed during an inspection?  Thanks for your input.

This message was posted by a user wishing to remain anonymous

Let me simplify so you are very clear to your question!

First thing, the FDA cGMP regulations and based on several pre-approval inspection citations, excipients can be accepted on vendor COA results based on qualification of each vendor/excipient as long as you have at least one id testing as incoming testing criteria for acceptance. I assume you probably either didn't know or wish to be too conservative to institute full testing as criteria for acceptance of excipients in your approved NDA.  If your original NDA states that all excipients will be tested as an acceptance criteria, then you should submit the change in Annual report with your new proposal. If you did not state anything in the approved NDA for acceptance of incoming excipients other than listing them with just Compendium status then it should be handled as an internal change control! Very simple process, hope this helps!
Just ignore all the complicated responses for a simple question! 
Original Message:
Sent: 16-Aug-2021 16:15
From: Anonymous Member
Subject: Regulatory Impact for Reduced Testing

This message was posted by a user wishing to remain anonymous

I work for a pharmaceutical company and we perform full testing of our excipients.  We are now implementing a reduced testing program where we will accept vendor COA results based on qualification of each vendor/excipient.  My question is, do we need to revise our filed excipient specification and notify FDA of this change in a supplement?  Is this just an internal change that would be reviewed during an inspection?  Thanks for your input.