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

They are the same thing

Answer

QC is only for pharmacists

Answer

QC refers to equipment and QA to personnel

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

Any CFU count greater than zero

Answer

Greater than 3 CFU per plate

Answer

Greater than 10 CFU per plate

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

To determine the market price

Answer

To satisfy insurance requirements

Answer

To test taste and appearance

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

Simply discard the failed product and continue

Answer

Wait until the next annual review

Answer

Assign blame to the technician

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

They only order supplies

Answer

They only perform final product verification

Answer

They manage financial accounts

Question 6

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

Accepted Answer

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

Answer

Any temperature reading is acceptable if used quickly

Answer

A normal variation requiring no action

Answer

Only affects non-sterile products