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  • Appendix 5 Check List For Change Control Assessment

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    flong
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    This check list outlines factors to consider when assessing changes to materials used in manufacturing processes. It separates factors into those relevant for non-critical materials versus critical materials. Critical materials require consideration of more factors like process validation, cleaning validation, equipment qualification, stability impact, testing requirements, regulatory impact, and downstream effects on customers.

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    Appendix 5

    Original Title

    Appendix 5

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    This check list outlines factors to consider when assessing changes to materials used in manufacturing processes. It separates factors into those relevant for non-critical materials versus critical materials. Critical materials require consideration of more factors like process validation, cleaning validation, equipment qualification, stability impact, testing requirements, regulatory impact, and downstream effects on customers.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    Download as doc, pdf, or txt
    16 views1 page

    Appendix 5 Check List For Change Control Assessment

    Uploaded by

    flong
    This check list outlines factors to consider when assessing changes to materials used in manufacturing processes. It separates factors into those relevant for non-critical materials versus critical materials. Critical materials require consideration of more factors like process validation, cleaning validation, equipment qualification, stability impact, testing requirements, regulatory impact, and downstream effects on customers.

    Copyright:

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

    Appendix 5

    Check List for Change Control Assessment

    Non Critical Materials Critical Materials


    Impact on site SOPs, batch documentation X X
    etc.
    Impact on supply X X
    Training of personnel X X
    Process validation X
    Cleaning Validation X X
    Equipment Qualification X
    Safety X X
    Environmental X X
    TSE assessment X X
    Stability Impact and the minimum period X
    before release
    Impact on testing of final product X
    Extra testing for material received X X
    Extra testing during production X
    Extra testing requirements to assess the X
    impact of the change
    Regulatory impact on the filed product with X
    all appropriate agencies.
     For new product, the filing strategy is
    developed in partnership with research.
     For old product the filing may be needed
    to be updated
    Down stream impact on customers X

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