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CPC Quality Assurance & Standards Flashcards

6 cards from real CPC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Traceability of measurement results in a laboratory context means that results can be related to:

    Answer: A stated reference through an unbroken chain of calibrations with stated uncertainties

    Metrological traceability requires an unbroken chain of comparisons to higher-level standards (ultimately to SI units or accepted references) with stated uncertainties at each link.

  2. In Good Laboratory Practice (GLP), a study director is responsible for:

    Answer: Overall conduct of the study and ensuring the study protocol is followed

    Under GLP regulations (FDA 21 CFR Part 58, EPA TSCA/FIFRA), the study director is the single point of study control, responsible for overall scientific conduct and protocol compliance.

  3. A laboratory's proficiency testing (PT) result is evaluated using a z-score. A z-score of |z| > 3 indicates:

    Answer: Unsatisfactory performance requiring corrective action

    In PT evaluation, |z| ≤ 2 is satisfactory, 2 3 is unsatisfactory, indicating the laboratory result is more than 3 assigned standard deviations from the consensus value.

  4. Under 21 CFR Part 11 (FDA), electronic records are acceptable if they include:

    Answer: Audit trails, access controls, and electronic signatures meeting specified requirements

    21 CFR Part 11 requires electronic records to have audit trails capturing changes, controlled access, secure electronic signatures, and system validation to ensure authenticity and integrity.

  5. The purpose of running a method blank in environmental analysis is to:

    Answer: Identify contamination introduced by the analytical process itself

    A method blank contains all reagents processed through the complete analytical procedure without the sample, detecting contamination from reagents, glassware, or laboratory environment.

  6. Recovery percentage in spiked sample analysis is calculated as:

    Answer: (Spiked result − unspiked result) / spike added × 100

    % Recovery = [(spiked result − unspiked result) / amount spiked] × 100, assessing how completely the method recovers the analyte from the sample matrix.