My opinion - provided that you (and the DS manufacturer) can both show that the ingredient was manufactured at the facility
prior to the deregistration of the facility and was able to meet all requirements for production, testing, release, etc. that the DS should be acceptable for use. Now I do think that there are a few significant caveats to this:
1. The paperwork showing the ingredient was produced before the deregistration needs to be even more meticulously managed and documented (in my opinion) than a "normal" lot because this will allow for proof of production in compliance with all requirements/regulations at the time of production of the ingredient;
2. You still will need to comply with any requirements for the DS that you agreed to during your review for approval. This also will hold true for your now deregistered supplier company.
3. I would generally keep up with any requirements that you had in place with the supplier as part of your supply agreements/quality agreements when they were registered and actively producing the DS for your use(s). Obviously some of this can be modified (e.g. you probably don't need full audits of their facility but I would ensure that all documentation required as part of your agreements remains updated and available for inspection should you need to review it or should an regulatory inspection require proof of any specific issues).
4. I would anticipate needing to prove that your DS manufactured by the now deregistered facility during an inspection/audit. Remember, it is really up to you to ensure you have the proper and necessary documents to show what was or was not done. I would request that copy of the deregistration notice that they sent to FDA with the actual date of deregistration and have that in my files because I would fully expect that an inspector is going to ask about it at some point. Make sure you have it, you have easy access to it, and that the date of deregistration
post-dates the date of production and release of your final shipment of the DS from that supplier.
5. Obviously there are many reasons why a company might choose to eliminate their registration for drug substances but I might also ask if the company is willing to share the reasoning for surrendering their FDA registration. If it is that you are the only company that would have required it, then it likely is counter-productive for the supplier to keep the registration and documentation and potential audits, etc. But if there are other reasons then I might want to consider those in regard to whether I continue to use the DS from that supplier from the later supplied material.
Hope some of this helps. Obviously these are my opinions and I really would look forward to other's comments on this as well.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 11-Jul-2021 03:48
From: Anonymous Member
Subject: US- How long should the drug substance manufacturer maintain its Drug Establishment Registration with FDA
This message was posted by a user wishing to remain anonymous
Hello everyone,
We have two Drug Substance (DS) manufacturers registered in our NDA.
For business reasons, one of them has stopped production; the last batch was produced in Jan 2021. This manufacturer has withdrawn their Establishment registration listing with FDA in Jun 2021.
Questions:
Would this be okay as the site was still registered with the FDA when the last DS batch was manufactured? OR
Should this DS site be registered with FDA until the lat drug product batch manufactured with this DS is expired?
Is there any guidance or regulation reference where this is explained?
Please share your experiences or knowledge around this.
Thanks