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  • ICH Q6 Decision Tree For Microbiology D PDF

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    The document describes a decision tree for determining the microbial quality attributes of drug substances and excipients. It involves assessing whether the drug substance or excipient is capable of supporting microbial growth, whether it is sterile, whether its synthesis or processing involves steps that inherently reduce microorganisms, and whether scientific evidence and monitoring data demonstrate levels below established acceptance criteria. The outcomes determine whether microbial limits, acceptance criteria, and testing are necessary or not.

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    ICH Q6 Decision tree for Microbiology d.pdf

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    The document describes a decision tree for determining the microbial quality attributes of drug substances and excipients. It involves assessing whether the drug substance or excipient is capable of supporting microbial growth, whether it is sterile, whether its synthesis or processing involves steps that inherently reduce microorganisms, and whether scientific evidence and monitoring data demonstrate levels below established acceptance criteria. The outcomes determine whether microbial limits, acceptance criteria, and testing are necessary or not.

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

    ICH Q6 Decision Tree For Microbiology D PDF

    Uploaded by

    mailtorubal2573
    The document describes a decision tree for determining the microbial quality attributes of drug substances and excipients. It involves assessing whether the drug substance or excipient is capable of supporting microbial growth, whether it is sterile, whether its synthesis or processing involves steps that inherently reduce microorganisms, and whether scientific evidence and monitoring data demonstrate levels below established acceptance criteria. The outcomes determine whether microbial limits, acceptance criteria, and testing are necessary or not.

    Copyright:

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