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  • 1.  eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 21-Jun-2016 17:53
    Hello,
     

    I am looking for the community's experience on the referenced eCTD section. Per Guidance for Industry M4Q the manufacturers section should contain contact data and responsibilities for each manufacturer including contractors, and each proposed production site or facility involved in manufacturing and testing.

    Per your experience, would a logistics provider, where packed and labeled DP is stored for distribution exclusively, need to be added to section 3.2.P.3.1?

     

    Thank you in advance for any feedback,

    Annette Hillebrand

     

     


  • 2.  RE: eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 22-Jun-2016 04:45

    Hi Annette,

    In my experience, eCTD section 3.2.P.3.1 would only list this provider if they were directly involved in or responsible for the packaging of the finished drug product. Generally the sites listed in 3.2.P.3.1 would include sites of drug product manufacture, primary and secondary packaging, quality control and release.

    I hope this provides some clarification,

    Daniel. 

    ------------------------------
    Daniel Kavanagh
    Associate Consultant
    Parexel International (IRL) Limited
    Inchicore
    Ireland

    Original Message


  • 3.  RE: eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 22-Jun-2016 08:16

    Hi Annette,

    I concur with Daniel. If the site is only helping you ship finished goods, I don't think this needs to go into 32p31.

    Cheers

    Bem

    ------------------------------
    Bem Atsma RAC
    Associate Director
    Biogen
    Cambridge MA
    United States

    Original Message


  • 4.  RE: eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 22-Jun-2016 08:56

    Dear Annette

     

    We do not include our 3rd party distributor in 3.2.P.3.1 and have never been questioned on this by FDA.

     

    Tom

    Chicago

     




    Original Message


  • 5.  RE: eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 22-Jun-2016 09:56
    Annette,

    ".... including contractors, and each proposed production site or facility involved in manufacturing and testing"

    No need to include those involved in distribution under the section 3.2.P.3.1, the section of which requires the description of those involved in manufacturing and testing. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message


  • 6.  RE: eCTD module 3, Drug Product section 3.2.P.3.1, Manufacturer

    Posted 23-Jun-2016 11:29

    Dears,

    Thank you all for your feedback and comments, you all confirmed my understanding of the guidance. I really appreciate the support of the community.

    Best,

    Annette

    ------------------------------
    Annette Hillebrand RAC
    Emeryville CA
    United States

    Original Message