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  • Questionnaries VENDOR QUALIFICATION

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    Dharmesh Patel
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    The document contains 5 questions related to vendor and supplier qualification for a pharmaceutical company. It asks who is responsible for identifying and assessing vendors, the frequency of re-qualification for secondary packaging (every 2 years) and raw materials (every 3 years), and whether a trial report and quality control test report are required for approving new raw materials. It also asks if a vendor can be approved based on a certificate of analysis and test report from an external lab.

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    questionnaries VENDOR QUALIFICATION

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    The document contains 5 questions related to vendor and supplier qualification for a pharmaceutical company. It asks who is responsible for identifying and assessing vendors, the frequency of re-qualification for secondary packaging (every 2 years) and raw materials (every 3 years), and whether a trial report and quality control test report are required for approving new raw materials. It also asks if a vendor can be approved based on a certificate of analysis and test report from an external lab.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    23 views1 page

    Questionnaries VENDOR QUALIFICATION

    Uploaded by

    Dharmesh Patel
    The document contains 5 questions related to vendor and supplier qualification for a pharmaceutical company. It asks who is responsible for identifying and assessing vendors, the frequency of re-qualification for secondary packaging (every 2 years) and raw materials (every 3 years), and whether a trial report and quality control test report are required for approving new raw materials. It also asks if a vendor can be approved based on a certificate of analysis and test report from an external lab.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Questio Question Marks

    n No. obtaine
    d
    1. Who is responsible to identify the vendor / supplier and to arrange
    vendor assessment from the respective vendor?

    2. Vendor may be qualified as an approved supplier based on the COA


    of pre-supplied sample and test report of RHIL Quality Control /
    External analytical testing laboratory.

    True / false

    3. Re – Qualification of Secondary printed packing material shall be


    conducted every 2 years

    True / false

    4. Re – Qualification of Raw materials (API and Excipients) shall be


    conducted every 3 years

    5. In case of New Raw Materials, approval shall be done based on


    Trial/Pilot scale Report and test report from QC.

    True / false

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