CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers 2

Question 1

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

Accepted Answer

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

Answer

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

Question 2

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

Accepted Answer

Greater than 1 CFU

Answer

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

Question 3

What is the purpose of end-product testing?

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 5

What role does the designated person play in quality assurance?

Accepted Answer

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

Answer

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

CSPT - Compounded Sterile Preparation Technician Practice Test