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  • 1.  GMP requirements for IND stability data

    Posted 26-Feb-2018 12:10
    ​Regulatory Community,

    Can anyone point me in the right direction to determine what the real GMP requirements are for stability data to support an IND, specifically, can I use non-GMP material to conduct my initial stability study?  I have read through the Guidance for Industry appropriate for INDs, particularly the one for cGMP for INDs.  I am having trouble reconciling what "representative material" means as I have not found a definition for it.

    Thanks,

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    William Coulston
    Quality & Regulatory Affairs
    San Antonio TX
    United States
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  • 2.  RE: GMP requirements for IND stability data

    Posted 27-Feb-2018 08:07
    Representative material implies material to be used in clinical trials. To proceed with FIH dosing, stability of the clinical trial material over the trial duration or more need to be demonstrated to FDA. Hope this helps.

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    Sudha Ankala Ph.D, PMP
    Edmond OK
    United States
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    Original Message


  • 3.  RE: GMP requirements for IND stability data

    Posted 27-Feb-2018 10:26

    Hi, William –

     

    It is absolutely possible to use development material to support initial stability.  "Representative material" is a catch-all term, and in practice, I tend to consider this similar to "comparable" – the manufacturing process, release test results, etc., must be similar enough to those of the material to be used in the study that it is appropriate to extrapolate the developmental lot information to the clinical trial material. 

     

    For FDA, this comes down to the strength of the scientific argument you can make.  If there are too many differences in the manufacturing process or the release tests, or if not enough quality attributes are being measured, you cannot justify the material as "representative".

     

    Also keep in mind that you are not required to set an expiry in the initial US IND.

     

    Best regards,

     

    Cathy

     

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC

     




    Original Message


  • 4.  RE: GMP requirements for IND stability data

    Posted 27-Feb-2018 21:11
    Hi William,

    I would totally agree with Cathy. It is certainly possible to use stability data from a non-GMP/pilot batch as supportive stability data for an initial IND filing. It will be nice to have the pilot batch manufactured as closely as possible to the first GMP batch that will be used for FIH study. For example, if you have done an engineering batch before doing the first GMP batch, the engineering batch could be put on stability and that data could be used during IND filling.

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    Partha Ghosh, PhD
    Germantown MD
    United States
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    Original Message


  • 5.  RE: GMP requirements for IND stability data

    Posted 28-Feb-2018 06:59
    Hi William,

    I concur with the other advice given that development batches can be used as representative stability assuming the manufacturing processes and analytical procedures are comparable to the GMP/clinical batch(es).  I also have found in the past few years that, in the IND, FDA wants to see at least 1 month of stability data on the intended clinical batch both at the intended storage condition and under accelerated storage.

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    Mark A. De Rosch, PhD, FRAPS
    Nashua, NH
    United States
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    Original Message


  • 6.  RE: GMP requirements for IND stability data

    Posted 28-Feb-2018 07:22

    I agree with Cathy and Partha's answers.

     

    Christopher Smith, CQE, RAC

    President, Coastal Pharmaceutical Consultants, Inc. ®

    7950 Old River Road, Burgaw, NC 28425 USA

    910-259-8877 (land)

    910-789-1232 (mobile)

    chrissmith@coastalpharmaconsultants.com

     




    Original Message


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