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  • Appendix 1 - CRITICAL NON-CRITICAL MATERIALS

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    This document provides examples of raw materials that are likely to be critical or non-critical in pharmaceutical manufacturing. It lists various raw material categories and indicates whether they are generally critical or non-critical, while noting that some categories marked with an asterisk may be critical if used in final API purification or isolation steps and should be reviewed as such.

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    Appendix 1_CRITICAL NON-CRITICAL MATERIALS

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    Appendix 1_CRITICAL NON-CRITICAL MATERIALS

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    This document provides examples of raw materials that are likely to be critical or non-critical in pharmaceutical manufacturing. It lists various raw material categories and indicates whether they are generally critical or non-critical, while noting that some categories marked with an asterisk may be critical if used in final API purification or isolation steps and should be reviewed as such.

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    67 views1 page

    Appendix 1 - CRITICAL NON-CRITICAL MATERIALS

    Uploaded by

    flong
    This document provides examples of raw materials that are likely to be critical or non-critical in pharmaceutical manufacturing. It lists various raw material categories and indicates whether they are generally critical or non-critical, while noting that some categories marked with an asterisk may be critical if used in final API purification or isolation steps and should be reviewed as such.

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    Appendix 1: Examples of likely Critical/ Non Critical Raw Materials

    Raw Material Critical Non Critical


    Acids X*
    API Starting Material X
    Bases X*
    Building Block X*
    Catalysts X
    Chromatographic resins X*
    Cleaning Agents/ detergents X*
    Enzymes X*
    Excipients used in API X
    formulations
    Filter Aids X
    Gasses – Process/Utility X*
    Grignard Reagents X
    Inorganic salts X
    Labels X
    Lubricants in contact with X
    products
    Media X*
    Processing Aids X
    Solvents X*
    Water X*

    X* Review criticality if used in final API Purification or isolation step.

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