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  2. Interagency Coordinating Committee on the Validation of ...

    en.wikipedia.org/wiki/Interagency_Coordinating...

    ICCVAM logo. The ICCVAM Authorization Act of 2000 created ICCVAM to "establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid safety testing methods that protect human and animal health and the environment while reducing, refining, and replacing animal tests and ensuring human safety and product ...

  3. Analytical quality control - Wikipedia

    en.wikipedia.org/wiki/Analytical_quality_control

    Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. [5] Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness.

  4. Verification and validation - Wikipedia

    en.wikipedia.org/wiki/Verification_and_validation

    Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000. The words "verification" and ...

  5. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  6. Laboratory quality control - Wikipedia

    en.wikipedia.org/wiki/Laboratory_quality_control

    Validation or verification is generally needed when a health facility acquires a new device to perform medical tests. The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring ...

  7. Clinical Laboratory Improvement Amendments - Wikipedia

    en.wikipedia.org/wiki/Clinical_Laboratory...

    Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level.

  8. OECD Guidelines for the Testing of Chemicals - Wikipedia

    en.wikipedia.org/wiki/OECD_Guidelines_for_the...

    Section 5: Other Test Guidelines; Guidelines are numbered with three digit numbers, the section number being the first number. Sometimes guidelines are suffixed with a letter. Guidelines are under constant review, with guidelines being periodically updated, new guidelines being adopted, and guidelines being withdrawn.

  9. Calibration curve - Wikipedia

    en.wikipedia.org/wiki/Calibration_curve

    A calibration curve plot showing limit of detection (LOD), limit of quantification (LOQ), dynamic range, and limit of linearity (LOL).. In analytical chemistry, a calibration curve, also known as a standard curve, is a general method for determining the concentration of a substance in an unknown sample by comparing the unknown to a set of standard samples of known concentration. [1]

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