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    Tag: Validation

    VALIDATION OF STERILE PACKAGE INTEGRITY

    Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…

    pharmastateacademy-2
    PharmaState Academy 29/12/2017
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    VALIDATION OF STERILE PACKAGE INTEGRITY 1

    Package integrity is validated by sterility testing. At present there are no recognized methods for performing a whole package microbial challenge; therefore the package may…

    pharmastateacademy-2
    PharmaState Academy 25/12/2017
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    PROCESS VALIDATION: GENERAL PRINCIPLES AND PRACTICES

    General Considerations for Process Validation: – In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make…

    pharmastateacademy-2
    PharmaState Academy 03/11/2017
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    HVAC SYSTEM VALIDATION TESTS

    AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and placed in front of the AHU. The distribution of…

    pharmastateacademy-2
    PharmaState Academy 19/08/2017
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    ANALYTICAL INSTRUMENT QUALIFICATION (AIQ) 1

    AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to…

    pharmastateacademy-2
    PharmaState Academy 14/08/2017
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