Regulatory Open Forum

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  • 1.  Product testing on finished dose packaging?

    Posted 08-Mar-2013 12:55
    Hi, For solid oral dosage forms, is it acceptable to perform finished product testing on bulk tablets before final packaging and only do confirmatory testing (id and appearance) after final packaging?  Or is FDA requiring something more/different - like finished product testing for release on finished dose packaging?

    Thanks!
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    Natalia Shunmugan
    Regulatory Affairs Intelligence
    Foster City CA
    United States
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  • 2.  RE:Product testing on finished dose packaging?

    Posted 11-Mar-2013 10:36
    Hi Natalia,

    Definition of Finished Product: "A product that has undergone all stages of production, including packaging in its final container and labelling."

    Regards,

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    Tom Namsavanh RAC
    Manager, Regulatory Affairs and Compliance
    Intelgenx Corp.
    Saint-Laurent QC
    Canada
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    Original Message


  • 3.  RE:Product testing on finished dose packaging?

    Posted 12-Mar-2013 08:21
    Natalia,

    Keep in mind, your packaging operation could have an adverse impact on the final dosage. In this case, micro contamination could occur during your packaging operation and thus the product could not be tested until it's in its final CCS.

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    John Lay
    Director, Regulatory and Quality
    Land O Lakes FL
    United States
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    Original Message