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  • 1.  BA/BE retain samples

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jul-2017 13:26
    This message was posted by a user wishing to remain anonymous

    Hello RAPS members,

    This might be a complicated question but I'll do my best. 

    FDA requires that the organization that conducts the BA/BE study are required to retain reserve samples with the intention to eliminate the possibility of sample substitution by the study sponsor/ Drug manufacturer, or prevent alteration of the samples from a study conducted by a contractor before release of the samples to the FDA. 

    When the testing facility goes out of business, it is their responsibility to transfer the reserve samples to an independent third party. 

    Now, in a hypothetical situation, if the independent third party destroys the samples because they did not receive payments from the testing facility, what should the ANDA holder do in this case? This can be a problem as the integrity of the study can come into question. 

    Are there any solutions other than repeating the entire study again?

    Thank you!

  • 2.  RE: BA/BE retain samples

    Posted 18-Jul-2017 23:37
    The situation you presented would be terrible in first instance, but every problem has solution that we all know.

    As company representative, you know the guidance and requirements. It means the sponsor is aware with the requirements and hopefully they made the contract/CDA with the testing lab (CRO) for storage of the reserve samples.

    It is responsibility of the CRO that when they transfer samples to third party, they must notify sponsor and hopefully they did as per their cotract/CDA.

    Third party destroy the sample for any commercial reason or something else, final conclusion is there is no reserve sample that supports the BA/BE study at the time of pre-approval.

    That is absolutely true that, no matter all responsibility is on sponsor.

    In this case, at that moment, sponsor should archive all the paper documents that trace the reserve sample from its dispatch to CRO, CRO to third party and third party destruction. Try to get the affidavit from the third party that they destroyed that reserve samples because whatever the reason. Keep all this documentation handy for the pre-approval inspection and you may present the scenario to the inspector that sponsor did all effort to trace and reserve the sample but due to unwanted circumstances they could not retrieve the reserve sample. As far as sponsor does not hide anything and present the documented evidence may save the sponsor from this situation. There could be possibility that inspector may take other retain samples to their laboratory for testing for assurance.

    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065

  • 3.  RE: BA/BE retain samples

    Posted 19-Jul-2017 09:59
    Hello RAPS Member,

    This is a very unfortunate situation. And there are high possibilities that FDA will ask the sponsor to do the Bio study again.

    Romita Mehta, MS, RAC
    Regulatory Affairs Manager
    Nostrum Laboratories, Inc.
    Kansas City, MO

  • 4.  RE: BA/BE retain samples

    Posted 19-Jul-2017 10:50
    ​Can you please clarify what samples? the drug product samples or the PK human (blood/serum/plasma etc) testing samples?
    Also, has your company previously got approval for an ANDA or is this the first time?


  • 5.  RE: BA/BE retain samples

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2017 14:17
    This message was posted by a user wishing to remain anonymous


    These are drug product samples. And yes, we have gotten ANDA approval in the past. 

    Thank you.