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  • 1.  Analytical Testing Laboratories referenced in DMF

    Posted 11-Jun-2020 17:11
    When a DMF is updated to include a new analytical testing laboratory for the final API, does the drug product application need to be updated? If so, can it be referenced in an Annual Report or does it need to be submitted in a supplement (CBE-30)?

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    Heather Hait
    Broomfield CO
    United States
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  • 2.  RE: Analytical Testing Laboratories referenced in DMF

    Posted 12-Jun-2020 03:42
    Hi Heather,

    If the new analytical testing lab has a satisfactory cGMP status, then in accordance with Section VI.C.1.d of Changes to Approved NDA or ANDA, this change can be filed as a supplement (CBE-30) (even though the finished product manufacturing site is not relying on them for test results). 

    Alternatively, if the new testing site has no satisfactory cGMP status, Prior Approval Supplement has to be filed.

    With respect to your 1st question, the drug production application (32S21) has to be updated. In addition, the Form FDA 356h has be updated to include this new testing lab in accordance with the Good ANDA Submission Practices.

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    Sravan, PharmD
    Officer, Regulatory Affairs
    Mylan Laboratories Limited
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    Original Message


  • 3.  RE: Analytical Testing Laboratories referenced in DMF

    Posted 12-Jun-2020 09:30
    Agree 100% with the response, this also applies to the NDA. Since analytical testing lab change for an API is part of confidential DMF, the NDA holder (drug product applicant using this API from the vendor) when submitting the supplement, they need to include the LOA from the DMF holder. The vendor of API not necessarily has to provide the analytical testing lab name to the NDA sponsor so Form 356 can only have the DMF LOA. The FDA dealing with the NDAs are ok with this but I don't know about ANDAs (FDA Generics Division).

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    GRSAOnline
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    Original Message


  • 4.  RE: Analytical Testing Laboratories referenced in DMF

    Posted 12-Jun-2020 11:38
    For addition of a new lab I've always followed FDA's PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites guidance from 1998 and submitted a CBE-30 as long as you meet the four criteria which I list in the cover letter. (1) the test method(s) approved in the application or methods that have been implemented under 21 CFR 314.70(d) are used, (2) all postapproval commitments made by the
    applicant relating to the test method(s) have been fulfilled (e.g., providing methods validation samples), (3) the new testing facility has the capability to perform the intended testing, and (4) the new testing facility has had a satisfactory current good manufacturing practice (CGMP) inspection within the past 2 years.

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    Tom
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


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