Regulatory Open Forum

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  • 1.  Process Validation Batches

    Posted 24-Jan-2016 18:45

    I have a question about the PV batches or conformance batches to be more accurate.  What are the regulatory requirements for the conformance batches to be commercialized and sent to the market.

    In other words is there a notification or filing involved to the FDA or is it fine to send the product made under the conformance batches to the market.

    Thanks

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    Zahid Muhammad
    Quakertown PA
    United States
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  • 2.  RE: Process Validation Batches

    Posted 24-Jan-2016 19:46
    Zahid,

    As for PV requirements, you may refer to CPG 400.100.  

    Thank you.  

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

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