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  • 1.  Post Approval Stability Commitment

    This message was posted by a user wishing to remain anonymous
    Posted 28-Jun-2018 11:09
    This message was posted by a user wishing to remain anonymous

    My firm is submitting a ANDA with the proposed commercial scale the same size as the primary batches. For the post approval stability commitments, do we still need to commit to long term and accelerated testing on the first 3 production batches, or can we claim the primary batches are production batches and only commit to finishing the long term testing on the 3 primary/production batches?

    Thanks


  • 2.  RE: Post Approval Stability Commitment

    Posted 29-Jun-2018 09:01
    ​If you submission batches are production scale you do not need accelerated for the first 3 commercial batches. This is outlined in ICH Q3A section 2.2.8.

    I would propose long-term only for post-approval and, worse case scenario, OGD comes back during review and asks you to add accelerated.

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    Cindy Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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    Original Message


  • 3.  RE: Post Approval Stability Commitment

    Posted 29-Jun-2018 10:56
    Based on ICH Q1(R2) section 2.2.8 - First three commercial lots needs to be placed in long-term and accelerated condition.

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    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


  • 4.  RE: Post Approval Stability Commitment

    Posted 10-Jul-2018 00:04
    Edited by Sailaja Chirravuri 10-Jul-2018 00:06
    As per ICH Q1(A) 2.2.8,

    Where the submission includes long term stability data from three production batches covering the proposed shelf life, a post approval commitment is considered unnecessary.

    If the submission includes data from stability studies on at least three production batches, a commitment should be made to continue the long term studies through the proposed shelf life and the accelerated studies for 6 months.

    Considering these statements, I think commitment should be given to continue the studies and placing 3 more batches on accelerated and long term might not be necessary. 

    Thanks,

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    Sailaja Chirravuri
    Regulatory professional
    Hyderabad
    India
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    Original Message


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