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OQ and CPP

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by leomac83, Jun 28, 2020.

  1. leomac83

    leomac83 Member

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    Hi,
    I've a question: Is it correct when I say that during an OQ protocol must be tested all the CPPs and their ranges?
    Thanks.

    Pharma GMP Annex 15:
    Critical process parameter (CPP): A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

    Operational Qualification (OQ): The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
     
    leomac83, Jun 28, 2020
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  2. leomac83

    leomac83 Member

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    Are there opinions? Anyone?
     
    leomac83, Nov 3, 2020
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