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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.

Read the first 6 CPC Quality Assurance & Standards flashcards as text

  1. What is the purpose of a certificate of analysis (CoA) for a chemical reagent used in the laboratory?

    Answer: To provide lot-specific test results confirming the reagent meets specified quality criteria

    A CoA provides lot-specific analytical data confirming identity, purity, assay value, and other critical quality attributes, allowing laboratories to verify suitability before use.

  2. Gage repeatability and reproducibility (Gage R&R) studies in measurement systems analysis evaluate:

    Answer: The contribution of measurement system variation to overall process variation

    Gage R&R quantifies repeatability (variation from the same operator/instrument) and reproducibility (variation between operators/conditions), partitioning measurement system variation from true part-to-part variation.

  3. In pharmaceutical QC, the United States Pharmacopeia (USP) general chapter describes requirements for:

    Answer: Validation of compendial procedures

    USP provides guidance on validating compendial methods, including categories for assay, impurity testing, and limit tests, with appropriate validation characteristics for each.

  4. Which corrective action tool is most commonly used to identify root causes of quality failures in a laboratory?

    Answer: Fishbone (Ishikawa) diagram

    The fishbone (Ishikawa or cause-and-effect) diagram is a systematic tool for brainstorming and categorizing potential root causes (people, process, equipment, materials, environment, measurement) of a quality problem.

  5. Under CLIA (Clinical Laboratory Improvement Amendments), laboratories must perform and document quality control at minimum:

    Answer: As specified by the method or at least each day of patient testing

    CLIA requires at minimum two levels of QC per day of patient testing for most quantitative tests (more for some high-complexity tests), with frequency specified by manufacturer or laboratory policy.

  6. The Limit of Quantitation (LOQ) in analytical chemistry is typically defined as:

    Answer: 10 times the standard deviation of a low-level blank or the signal-to-noise ratio of 10:1

    The LOQ (often set at 10σ or S/N ≥ 10) is the lowest concentration that can be quantitatively measured with acceptable accuracy and precision, above the detection limit (3σ or S/N ≥ 3).