Regulatory Open Forum

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  • 1.  Request for recommendations for finished good testing services

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jan-2017 16:55
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I work for a very small organization and we are looking for a testing service to perform regular finished good lot testing for our product.  These will be product specific tests (not ISO 10993 or other similar tests) and we will work with the service to provide training.  If you could provide me with any suggestions for testing services providers I would really appreciate the help.

    Thank you.



  • 2.  RE: Request for recommendations for finished good testing services

    Posted 12-Jan-2017 06:41
    What kind of testing are you looking for? In vivo or in vitro? Can you provide more details?
    You can contact me at ZuzanaKarjala@PacificBioLabs.com If you would like to discuss.


    Thank you.
    Zuzana

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    Zuzana Karjala
    El Cerrito CA
    United States
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  • 3.  RE: Request for recommendations for finished good testing services

    Posted 12-Jan-2017 10:14

    Are you looking for device, biologic, or small molecule testing? And is any of the testing compendial? 

     

    Best,

     

    Cathy



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    Catherine Anderson PHD
    Senior Manager - Regulatory CMC
    Hillsborough NC
    United States
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  • 4.  RE: Request for recommendations for finished good testing services

    Posted 12-Jan-2017 10:55
    As I understand these are product specific Lot release test.  For such tests you are required to have a in house validated Test Method protocol that you expect your contractor to follow.  First step is to establish a quality agreement specifying roles and responsibilities of the testing lab, 2nd step is to write a method transfer protocol, have it approved by both the parties, third step execute the method transfer protocol, then write a report on the outcome of the transfer, once the pre set acceptance criteria are met, contract lab is ready to conduct routine testing for your product using your method

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    Dalip S. Gill, PhD, United States
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