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    GLP Vs 17025

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    Nadhra Halig
    ISO 17025 and GLP are standards for laboratory quality management systems and non-clinical research studies. ISO 17025 is intended for repetitive testing in ISO member countries, with quality systems described in a quality manual, while GLP is for single studies in OECD member countries, with quality systems in SOPs. GLP has more specific personnel responsibilities and record retention requirements than ISO 17025 and requires study plans, validated methods, and storage of samples and data until results are accepted.

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    GLP Vs 17025

    Uploaded by

    Nadhra Halig
    1K views6 pages
    ISO 17025 and GLP are standards for laboratory quality management systems and non-clinical research studies. ISO 17025 is intended for repetitive testing in ISO member countries, with quality systems described in a quality manual, while GLP is for single studies in OECD member countries, with quality systems in SOPs. GLP has more specific personnel responsibilities and record retention requirements than ISO 17025 and requires study plans, validated methods, and storage of samples and data until results are accepted.

    Original Description:

    This documents categorise the differences between Good Laboratory Practice (GLP) and ISO 17025

    Original Title

    GLP vs 17025

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    ISO 17025 and GLP are standards for laboratory quality management systems and non-clinical research studies. ISO 17025 is intended for repetitive testing in ISO member countries, with quality systems described in a quality manual, while GLP is for single studies in OECD member countries, with quality systems in SOPs. GLP has more specific personnel responsibilities and record retention requirements than ISO 17025 and requires study plans, validated methods, and storage of samples and data until results are accepted.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    1K views6 pages

    GLP Vs 17025

    Uploaded by

    Nadhra Halig
    ISO 17025 and GLP are standards for laboratory quality management systems and non-clinical research studies. ISO 17025 is intended for repetitive testing in ISO member countries, with quality systems described in a quality manual, while GLP is for single studies in OECD member countries, with quality systems in SOPs. GLP has more specific personnel responsibilities and record retention requirements than ISO 17025 and requires study plans, validated methods, and storage of samples and data until results are accepted.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 6

    What is the differences

    between GLP & ISO 17025?

    ISO 17025

    VS

    GLP

    1. ISO Members
    2. The same
    standard for all
    ISO
    3. Designed for
    repetitive studies
    4. Description of
    Quality System in
    Quality Manual

    1. OECD Members
    2. Different
    regulations in
    different countries
    3. Designed for
    single studies
    4. Description of
    Quality System in
    SOPs

    ISO 17025

    VS

    GLP

    1. General
    statements for
    responsibilities of
    personnel
    2. No specific
    requirements for
    storage of records
    and reports

    1. Very specific
    responsibilities of
    personnel
    2. Specific
    requirements for
    storage, retention
    and archiving

    ISO 17025

    VS

    GLP

    1. No study plans
    required
    (standardized
    methods should
    be used)
    2. Written operating
    procedures
    without specific
    format

    1. Study plan
    required for each
    study

    1. SOPs with detailed


    requirements for
    format and
    content

    ISO 17025

    VS

    GLP

    1. Analysis methods
    1. Validation through
    must be verified
    inter-laboratory
    through intertests not required
    laboratory test (PT) 2. In case of
    2. Documented
    problems, only
    complaints
    course of law
    procedures
    3. Storage of test
    1. Storage of test
    samples and data
    samples according
    until client accepts
    to local regulatory
    results
    requirements

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