Agreed with Mehul and usually, if someone develops an alternate method to the assigned USP one, the test developer must go thru USP to show equivalency. USP will share the protocols on how to do the validation. And when USP indicates that the new method passes/meets the equivalency conditions, then you should request advice from the FDA where the results can be shared. The FDA like EMA is not in the business, nor does have the resources, to validate alternate methods. It is up to the applicant to do so. However, before going to any new methodology, what is the financial/technical incentive to pursue an alternate method? Method development is quite costly and from experience, alternate methods may not be as good as the ones listed in the USP Compendium (except for Heavy Metals / Residues but it was already known that USP 231 - 233 needed a major overhaul).
Hopefully, this should help.
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[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]
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Original Message:
Sent: 25-Jun-2018 09:53
From: Mehul Govani
Subject: Method Equivalancy
Hello,
As per the the FDA guidance "Refuse to Receive standards" (Page 10) In-house methods used in lieu of USP methods should be compared to the USP method to support a demonstration that the in-house method is sufficient.
Thanks,
Mehul
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Mehul Govani RAC
Regulatory Affairs Manager
Westbury NY
United States
Original Message:
Sent: 25-Jun-2018 09:19
From: Christian Phipps
Subject: Method Equivalancy
Hi all,
We have developed and validated our in-house test methods, used in both drug product release and stability, and used them in lieu of the USP methods. Will the FDA RTR an application if no method equivalency study was performed?
If so, is there any guidance to follow for developing the protocol for the method equivalency study?
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Thanks for your help,
Christian Phipps
Cranbury, NJ
United States
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