Regulatory Open Forum

 View Only

  • 1.  Combination Product Stability Question

    Posted 02-Aug-2019 16:36

    Hi everyone, 

    I am hoping to get some guidance/feedback on stability requirements/expectations for a drug-device combination product (co-packaged combination product (drug-delivery device). 
    What's the minimum stability data required prior to BLA and MAA submission? And do you typically set the expiry date based on the constituent with the shortest shelf life or do you set the expiry date based on the entire combination product?
    We were planning on submitting with 6 months RT and Acc. data of the DRUG and establishing the expiration date on the drug. 

    Are you aware of any requirements (or guidance documents) for also submitting combination product shelf life data (i.e. functionality testing of the delivery device and drug product quality post-delivery device) even if the expiration date is solely based on the drug? 

    Any information you can share is greatly appreciated. 

    Thanks and have a good week-end!

    Sabrina 



    ------------------------------
    Sabrina Dessources
    Boston MA
    United States
    ------------------------------


  • 2.  RE: Combination Product Stability Question

    Posted 04-Aug-2019 07:49

    Hi Sabrina,

     

    In order to give a clear answer, you would need to provide information on the device.  If it is an "off-the-shelf" device and you are not "processing" it (re-sterilizing, etc.), then you would not need stability or expiration data (functional or package integrity) on the device.   If the device is not previously cleared or approved, or is modified or processed, then you need to provide stability or supporting data on the expiration (functional or package integrity) on the device, at least to the expiration date on the box, which is usually limited by the drug expiration date.

     

    Regardless, the expiration on the co-packaged product is always the shortest expiration of the components in the package.

     

    As for guidance, many of the FDA guidance document expect information on the performance of the device at the end of expiration. Again, even if not in a guidance, theis is a requirement.

     

    Lee

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


  • 3.  RE: Combination Product Stability Question

    Posted 05-Aug-2019 23:46
    Hi Sabrina,

    Thank you for asking the question and I appreciate more information to provide you with more accurate suggestions.

    But please consider some general points:
    1. The combination products stability profile needs to consider using aged components to build up your data base. For example, if you claim your device shelf life is 5 years and your drug's is 1 year, then you probably need to put together both aged components to study the stability of the combination product.
    2. In addition to necessary drug's testing, the device performance testing must also be built in your stability specification till the end of shelf life of the combination product you claim.

    Please feel free to reach out to me if you want to explore more specifics.

    Gene Zhu, Ph.D., RAC


    ------------------------------
    Gene Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
    ------------------------------

    Original Message


  • 4.  RE: Combination Product Stability Question

    Posted 05-Aug-2019 10:45
    Hi Sabrina,
    I work on combination products.  My experience has been the combination product shelf-life is based on the consistent with the least amount of shelf-life data.   You need to look at the expiration date for all items going into the package and whichever items will expire first, becomes the expiration date for the combo product.  

    As far as minimums go, It is really whatever your company can tolerate and what the market will demand.  I've had products with proposals for only 6 months, but in the distribution and supply chain, that can be very difficult to manage.  Often end customers will want to see a minimum of several months of shelf-life once they receive it, so 6 months from start of production, to patient use, can be difficult if not impossible.  
    I hope that helps.
    Sara


    ------------------------------
    Sara Coon
    Director, Regulatory Affairs
    MN United States
    ------------------------------

    Original Message


  • 5.  RE: Combination Product Stability Question

    Posted 06-Aug-2019 14:14
    Thank you everyone for the information. 

    Sabrina

    ------------------------------
    Sabrina Dessources
    Boston MA
    United States
    ------------------------------

    Original Message


Related Content