Regulatory Open Forum

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  • 1.  Number of API Lots

    Posted 16-Feb-2020 09:35
    Dear Colleagues,

    Is it acceptable to submit a NDA with 3 drug product registration batches manufactured with 2 different lots of API rather than 3?

    Thank you for your asiatnce.

    Best regards,
    David Lucking

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    David Lucking
    FL
    United States
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  • 2.  RE: Number of API Lots

    Posted 17-Feb-2020 08:27
    Yes. It is in fact not unusual to have the registration batches from one API lot. Registration batches are manufactured to demonstrate that the Drug Product can be made consistently.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Number of API Lots

    Posted 17-Feb-2020 12:04
    Yes. FDA's Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products states "Where possible, batches of the drug product should be manufactured by using different batches of the drug substance.".  I would manufacture DP registration batch #1 with API Lot #1, DP registration batch #2 with API Lot #2, and then DP registration batch #3 with a mix of API Lots #1 & 2.  ​​​

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    Tom
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


  • 4.  RE: Number of API Lots

    Posted 18-Feb-2020 04:10
    Yes, 2 lots of API can be used for  3 DP batches manufacturing. However more than 2 would be a worse case scenario as per ICH guideline.

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    Deepa Dasgupta RAC
    Director
    Hyderabad
    India
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    Original Message


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