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  • 1.  Analytical procedure change for Assay-of approved ANDA

    Posted 15-Aug-2023 08:21

    Hello All,

    I want guidance for one  approved injection ,in which  if change in analytical method from specific to nonspecific method for drug product is annual reportable or CBE.

    USP mentioned titration method for assay. Now application approved by Ion chromatographic method for assay. Method equivalency already submitted in application.

    Now for commercial ion chromatography not worked due to instrument issue.so again need to perform assay by USP titration.

    Change in method considered as Annual reportable or CBE or PAS? please guide.

    Regards,

    Sapna



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    sapna rathi
    Regulatory specialist
    AHME
    India
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  • 2.  RE: Analytical procedure change for Assay-of approved ANDA

    Posted 16-Aug-2023 09:36

    Hello,

    Initially at least, I would be less concerned about the specific type of notification to FDA (PAS, CBE-30, CBE-0 or Annual Report).

    First and foremost, you should be certain (based on sound data) that product has not been, nor is being released to the market based on an analytical method that may be unreliable, unvalidated or both.  Attributing the reason for the method change to an "instrument issue" could very well beg more questions than it answers.

    Regards,



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    Mark Lookabaugh
    Principal
    Mark Lookabaugh Consulting, LLC
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    Original Message


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