Practice Test GeeksCSPT - Compounded Sterile Preparation Technician Practice Test
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Quality Control and Assurance Flashcards

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

Read the first 6 Quality Control and Assurance flashcards as text

  1. What is the difference between quality control (QC) and quality assurance (QA)?

    Answer: QC involves testing individual products, while QA encompasses the entire system of policies and oversight

    QC consists of specific product-focused testing activities, while QA is the comprehensive system of procedures, training, monitoring, and oversight.

  2. What action level triggers an investigation for viable air sampling in an ISO Class 5 PEC?

    Answer: Greater than 1 CFU

    In an ISO Class 5 PEC, the action level for viable air sampling is greater than 1 CFU.

  3. What is the purpose of end-product testing?

    Answer: To verify the final CSP meets specifications for identity, potency, sterility, and pyrogen content

    End-product testing verifies that the finished CSP meets all quality specifications before release for patient use.

  4. How should corrective and preventive actions (CAPA) be implemented?

    Answer: Identify root cause, implement corrective action, develop preventive measures, document everything, verify effectiveness

    CAPA requires systematic root cause analysis, immediate correction, preventive measures, documentation, and follow-up verification.

  5. What role does the designated person play in quality assurance?

    Answer: They have overall responsibility for the quality of CSPs including all operations and quality systems

    The designated person bears overall responsibility for the entire sterile compounding program.

  6. What is a temperature excursion and how should it be handled?

    Answer: A deviation from the specified storage temperature requiring investigation and assessment of affected products

    A temperature excursion requires investigation, assessment of all affected CSPs, potential product discard, equipment repair, and documentation.

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