CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers 2 — Questions and Answers
Question 1: What is the difference between quality control (QC) and quality assurance (QA)?
- They are the same thing
- QC involves testing individual products, while QA encompasses the entire system of policies and oversight (Correct answer)
- QC is only for pharmacists
- QC refers to equipment and QA to personnel
Correct 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.
A facility needs both: the best QC testing cannot compensate for poor QA systems, and the best QA systems still require QC verification of individual products.
Question 2: What action level triggers an investigation for viable air sampling in an ISO Class 5 PEC?
- Any CFU count greater than zero
- Greater than 1 CFU (Correct answer)
- Greater than 3 CFU per plate
- Greater than 10 CFU per plate
Correct answer: Greater than 1 CFU
In an ISO Class 5 PEC, the action level for viable air sampling is greater than 1 CFU.
When the action level is exceeded, compounding must be suspended, the cause investigated, corrective actions implemented, and the environment re-sampled to verify return to acceptable levels.
Question 3: What is the purpose of end-product testing?
- To determine the market price
- To verify the final CSP meets specifications for identity, potency, sterility, and pyrogen content (Correct answer)
- To satisfy insurance requirements
- To test taste and appearance
Correct 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.
Testing may include visual inspection, pH testing, potency testing, sterility testing, and endotoxin testing depending on the compounding category and route of administration.
Question 4: How should corrective and preventive actions (CAPA) be implemented?
- Simply discard the failed product and continue
- Identify root cause, implement corrective action, develop preventive measures, document everything, verify effectiveness (Correct answer)
- Wait until the next annual review
- Assign blame to the technician
Correct 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.
The CAPA process transforms individual failures into opportunities for systemic improvement using tools like fishbone diagrams and 5-Whys analysis.
Question 5: What role does the designated person play in quality assurance?
- They only order supplies
- They have overall responsibility for the quality of CSPs including all operations and quality systems (Correct answer)
- They only perform final product verification
- They manage financial accounts
Correct 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.
While they may delegate specific tasks, they cannot delegate the overall accountability for quality. They must have the education, training, and experience to understand all aspects of sterile compounding.
Question 6: What is a temperature excursion and how should it be handled?
- Any temperature reading is acceptable if used quickly
- A deviation from the specified storage temperature requiring investigation and assessment of affected products (Correct answer)
- A normal variation requiring no action
- Only affects non-sterile products
Correct 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.
If stability data cannot confirm products are still acceptable, they must be discarded. Even brief excursions can be significant for proteins and biologics.
CSPT - Compounded Sterile Preparation Technician Quality Control and Assurance Questions and Answers 2
What is the difference between quality control (QC) and quality assurance (QA)?