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  • 1.  Outsourcing supplier qualification audits

    Posted 10/06/20 11:49 AM
    I am looking into the feasibility of outsourcing supplier qualification audits for some of my company's international suppliers. We are a biotech company that makes a process aid for use in biopharmaceutical manufacturing which is not subject to GMP requirements. 

    I would like the community's input on reputable, independent firms who can be contracted to perform such audits on our behalf. Thanks!


  • 2.  RE: Outsourcing supplier qualification audits

    Posted 10/19/20 01:13 PM
    Hi Brittany Crocco‍  - I pinned this to the top, hoping someone might know someone....doesn't seem to be helping.  I'll trying tagging a few people I know in hopes they might be able to help you. 

    James Rooney‍ , Duke Okes‍ , Amanda Foster‍ , Susanne Burke‍, Billi Jo Johnson‍ - Could you provide any insights?  

    Thanks

    Trish


  • 3.  RE: Outsourcing supplier qualification audits

    Posted 10/20/20 10:10 AM
    No recommendations here but I would personally start by searching the web for auditing firms located in the country/region where the suppliers are located.


    And of course, depending on how complex the purchased component is a virtual audit along with prototype analysis (if feasible from a cost standpoint) could suffice, especially if supported by communications with other customers of the same supplier.


  • 4.  RE: Outsourcing supplier qualification audits

    Posted 10/21/20 09:57 AM
    Brittany - try this - I have seen many of our customers have used their services to audit their suppliers. https://www.sqaservices.com/our-process/stepq/  

    And the other option is to try Quality Auditing - https://www.qualityauditing.com/general-inquiries/services/


  • 5.  RE: Outsourcing supplier qualification audits

    Posted 10/21/20 10:30 AM
    Thank you all for your input! I am on my way with getting an audit scheduled now and appreciate your responses.