Regulatory Open Forum

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  • 1.  Vendor Qualification

    Posted 29-Jul-2014 11:18
    I am putting together a vendor qualification SOP and questionaire for our small biotech company.  Does anyone have a SOP or questionaire template that you are willing to share? I would be most appreciative of any suggestions.

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    Monica Jones
    Regulatory Assurance and Product Compliance
    Altor Bioscience Corporation
    Miramar FL
    United States
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  • 2.  RE: Vendor Qualification

    Posted 29-Jul-2014 12:23
    Monica,

    This is not what you've asked for.

    However, I found it very useful concerning "supplier control including supplier evaluation and acceptance: qualification" especially if you are developing your supplier/vendor control procedures.

    You may refer to GHTF/IMDRF supplier guidance.

    Otherwise, you may get it at http://www.regulatorydoctor.com/guidance-on-the-control-of-products-and-services-obtained-from-suppliers/

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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 3.  RE: Vendor Qualification

    Posted 30-Jul-2014 07:27
    Dear Monica

    such documents are accessible for free on this website http://apic.cefic.org/publications.html
    just scroll down and ou will find the supplier qualification topic

    Best regards
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 4.  RE: Vendor Qualification

    Posted 31-Jul-2014 08:30
    Ms. Jones:
       We (Gad Consulting Services) perform GMP and GLP audits and monitoring globally for clients in the pharmaceutical and medical device fields, including qualification audits.
       As part of this, we have developed (and, as life and regulations go on, continue to update audit check lists. We would be glad to share specific electronic template copies of these upon request.

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    Shayne Cox Gad PhD
    Principal
    Gad Consulting Services
    Cary NC
    United States
    www.gadconsulting.com
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    Original Message


  • 5.  RE: Vendor Qualification

    Posted 01-Aug-2014 15:41

    This website is very helpful. Thank you for sharing.
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    Andrea Stewart
    Fremont CA
    United States
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    Original Message


  • 6.  RE: Vendor Qualification

    Posted 04-Aug-2014 09:46
    To all of you who have offered help and sent great information to me about vendor qualifications - Thank you so much for the help.  This forum continues to be a great resource for me.

    Monica

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    Monica Jones
    Regulatory Assurance and Product Compliance
    Altor Bioscience Corporation
    Miramar FL
    United States
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    Original Message