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  • Introdução Qualidade Assegurada

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    The document discusses quality assurance in analytical labs. It describes quality management as the system used to manage, determine, and control quality according to standards like GLP, GMP, ISO9001. It defines quality assurance as activities like method validation, standardization of reagents, and round robins to measure and maintain quality. Qualification is described as activities like training, maintenance, and certification to check and ensure proper functioning of analytical instruments.

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    INTRODUÇÃO QUALIDADE ASSEGURADA

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    The document discusses quality assurance in analytical labs. It describes quality management as the system used to manage, determine, and control quality according to standards like GLP, GMP, ISO9001. It defines quality assurance as activities like method validation, standardization of reagents, and round robins to measure and maintain quality. Qualification is described as activities like training, maintenance, and certification to check and ensure proper functioning of analytical instruments.

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    3 views8 pages

    Introdução Qualidade Assegurada

    Uploaded by

    juka andrade
    The document discusses quality assurance in analytical labs. It describes quality management as the system used to manage, determine, and control quality according to standards like GLP, GMP, ISO9001. It defines quality assurance as activities like method validation, standardization of reagents, and round robins to measure and maintain quality. Qualification is described as activities like training, maintenance, and certification to check and ensure proper functioning of analytical instruments.

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    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
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    of 8

    Quality Assurance in the

    Analytical Lab

    Analytical METTLER
    TOLEDO
    Quality?
     Depends on the requirements

    Analytical METTLER
    TOLEDO
    Quality of Test Data
     Accuracy, precision

    depend on the requirement!

    Analytical METTLER
    TOLEDO
    Quality Management
     The system used to manage, determine and control quality!

    Strategic!
    GLP, GMP, GALP
    ISO9001, EN45000, EN ISO 14000

    Analytical METTLER
    TOLEDO
    The Beginning of GLP

    Set of principles by FDA: 20. June 1978

    Guidelines for testing chemicals: OECD in 1981

    Switzerland: adopted them in 1982

    EC: 18. 12. 86, 7. 6. 88, 18. 12.89

    Analytical METTLER
    TOLEDO
    Quality Assurance
     Activities and applications used to measure and maintain
    quality

    Tactical!
    Method validation
    Standardisation of titrants
    Round Robins
    Use of reference substances

    Analytical METTLER
    TOLEDO
    Qualification
     Actvities and applications used to check and maintain proper
    functioning of analytical instruments

    Operational!
    Training
    Maintenance
    Certification

    Analytical METTLER
    TOLEDO
    Summary:
     Quality Management:
    A set of principles regarding organisation, planning, performing,
    controlling and reporting.

     Quality Assurance:
    Validation of methods, system suitability tests (SST),
    standards as samples.

     Qualification:
    Among other things: check if instrument fulfils specification.

    Analytical METTLER
    TOLEDO

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