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  • 1.  Blow-Fill-Seal Minimum Batch Size

    This message was posted by a user wishing to remain anonymous
    Posted 13-May-2019 16:45
    This message was posted by a user wishing to remain anonymous

    ​Hello everyone,  what is the minimum batch size (packaged unit count) for Blow-Fill-Seal packaging for an NDA with the US FDA?  For tablets and capsules, 100,000 units is typically acceptable, for example.  Does anyone know the minimum units for BFS?

    Thank you.


  • 2.  RE: Blow-Fill-Seal Minimum Batch Size

    Posted 14-May-2019 09:57
    We use the recommendations in the ANDA Stability Q&A Guidance.​

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Lebanon NJ
    United States
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    Original Message


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