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  • 1.  Stability requirements for ANDAs

    Posted 27-Aug-2013 12:35

    Hello Group,

    Looking at the draft guidance "ANDA's: Stability testing of Drug Substances and Products Questions and Answers"  released by the FDA yesterday, I have a few questions regarding the stability requirements.
     
    1. In case of a dose proportional blend for a product that has two strengths (example: 10 mg and 20 mg) is it necessary to make three batches of each strength i.e., 3 batches for 10 mg and 3 batches for 20 mg?

       

    2. Also as per one of the Q&A in the guidance:
     Q19:  In cases where an intermediate bulk material is identical between the various strengths (dose proportional blends, bulk solutions, etc.), is it sufficient to perform stability on one lot of each strength, when each strength is produced from a separate intermediate bulk?  

    A19:  No. For ANDAs that contain multiple strengths (that are dose proportional), three

    separate intermediate bulk granulations (or blends) should be manufactured.  One

    batch of bulk granulation (or blend) should be used to manufacture all the

    strengths proposed.  The other two bulk granulations (or blends) can be used to

    manufacture only the lowest and the highest strengths, in addition to the strength

    used in BE studies.  Stability testing should still use all three batches of drug

    product.

     

    As per the highlighted section, do we need to manufacture a batch large enough for 100,000 units of each of the strengths (Example: 100,000 for 10 mg and 100,000 for the 20 mg?)

    Appreciate any help in this matter.

    Thanks,
    Mehul
    -------------------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
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  • 2.  RE:Stability requirements for ANDAs

    Posted 30-Aug-2013 14:11
    Hello,

    To the best of my knowledge you need to manufacture 3 master blend(2 pilot and 1 small) which will split(via dose proportion)  into 2 different strength 10 &20mg.

    For each strength you need to fulfill the batch requirement of 100,000(for 2 pilot) and 25%(for small batch).

    except if

    -The reference listed drug product has an orphan drug designation.
    -Use of a controlled drug substance is based on a Drug Enforcement Administration allocation.
    -The test batch size is the same as the commercial batch size with the commitment that a prior approval supplement (PAS) will be provided when there is a scale-up.

    Best regards
    -------------------------------------------
    Amit Jain

    United States
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