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    Inspection Feedback Form Interpretation Requirements

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    SANTHOSH MOORTHY
    This 3 sentence summary provides the key details from the document: This document is an inspection feedback form from the Therapeutic Goods Administration (TGA) that manufacturers can use to provide comments on how TGA inspectors interpreted GMP/QMS requirements during an inspection, with the goal of improving consistency and training, while manufacturer and inspector details will remain confidential. The form requests manufacturer and inspection details, and asks the manufacturer to describe any situations where they believe the inspector incorrectly interpreted requirements, and whether the issue led to a deficiency and if there was opportunity for discussion.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Inspection Feedback Form Interpretation Requirements

    Uploaded by

    SANTHOSH MOORTHY
    23 views2 pages
    This 3 sentence summary provides the key details from the document: This document is an inspection feedback form from the Therapeutic Goods Administration (TGA) that manufacturers can use to provide comments on how TGA inspectors interpreted GMP/QMS requirements during an inspection, with the goal of improving consistency and training, while manufacturer and inspector details will remain confidential. The form requests manufacturer and inspection details, and asks the manufacturer to describe any situations where they believe the inspector incorrectly interpreted requirements, and whether the issue led to a deficiency and if there was opportunity for discussion.

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    inspection-feedback-form-interpretation-requirements.docx

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    This 3 sentence summary provides the key details from the document: This document is an inspection feedback form from the Therapeutic Goods Administration (TGA) that manufacturers can use to provide comments on how TGA inspectors interpreted GMP/QMS requirements during an inspection, with the goal of improving consistency and training, while manufacturer and inspector details will remain confidential. The form requests manufacturer and inspection details, and asks the manufacturer to describe any situations where they believe the inspector incorrectly interpreted requirements, and whether the issue led to a deficiency and if there was opportunity for discussion.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    23 views2 pages

    Inspection Feedback Form Interpretation Requirements

    Uploaded by

    SANTHOSH MOORTHY
    This 3 sentence summary provides the key details from the document: This document is an inspection feedback form from the Therapeutic Goods Administration (TGA) that manufacturers can use to provide comments on how TGA inspectors interpreted GMP/QMS requirements during an inspection, with the goal of improving consistency and training, while manufacturer and inspector details will remain confidential. The form requests manufacturer and inspection details, and asks the manufacturer to describe any situations where they believe the inspector incorrectly interpreted requirements, and whether the issue led to a deficiency and if there was opportunity for discussion.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    TGA use only

    This form, when completed, will be classified as 'For official use only'.
    For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at
    <https://www.tga.gov.au/treatment-information-provided-tga>.

    Inspection feedback form – Interpretation of


    requirements

    Please note
    The terms ‘inspection’ and ‘inspector’ are synonymous with the terms
    ‘audit’ and ‘auditor’ used by the Medical Devices Branch.

    Important notice
    This form is intended to provide the TGA with comments about the interpretation of the
    Manufacturing Principles, Code of GMP, ISO 13485, conformity with the Essential Principles, and
    the legislative framework. Feedback received will be used to assess the consistency of inspectors’
    interpretations and assist in our training programs.
    Feedback received in this form will not be treated as a complaint. If you wish to lodge a
    complaint, please follow the Inspection & inspectors complaint process
    It is necessary for the purposes of continuous improvement to identify both the manufacturer and
    the inspector(s) involved. These details will be kept strictly confidential and will be de-identified for
    training purposes and/or any corrective action.
    For information about how your personal information is protected under the Privacy Act 1988
    please go to <https://www.tga.gov.au/privacy>.

    Part 1: Manufacturer and inspection details

    Manufacturer      

    Address of
    manufacturing      
    premises

    Date of Inspector(s)
    inspection(s)
          names
         

    Please provide me with a reply.


    No reply is required.

    PO Box 100 Woden ACT 2606 ABN 40 939 406 804


    Phone: 1800 020 653 Fax: 02 6203 1605 Email: [email protected] https://www.tga.gov.au/
    Reference: R16/955277
    Name       Position      

    Signature Date      

    The TGA thanks you for your comments.

    Part 2: Interpretation of GMP/QMS requirements


    Describe the situation(s) where you believe the inspector(s) did not correctly interpret the
    requirements of the Manufacturing Principles, Code of GMP or ISO standard, Essential Principles
    and/or the regulatory framework. You should provide as much detail as possible and explain why
    you believe the practice or process (leading to a deficiency or nonconformity) should have been
    interpreted differently. Add additional pages if required.

    Comments:

         

    Yes No

    Did the interpretation lead to a critical or major deficiency/nonconformity?

    Was the deficiency/nonconformity included in the items for discussion


    provided to you at the conclusion of the inspection?

    Did the inspector clearly explain the rationale for the


    deficiency/nonconformity?

    Did you have the opportunity to discuss your views?

    Inspector Feedback Form – Interpretation of requirements (June 2017) Page 2 of 2


    For official use only

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