CSPT Quality Control and Assurance 4 — Questions and Answers
Question 1: Which statistical method is used to determine if a compounding process is within acceptable limits by plotting data points over time?
- Control chart (Shewhart chart) (Correct answer)
- Pareto analysis
- Fishbone diagram
- Failure mode and effects analysis
Correct answer: Control chart (Shewhart chart)
Control charts (Shewhart charts) plot process data over time to detect trends or shifts that indicate the process is out of statistical control.
Question 2: A batch of sterile compounded preparations fails particulate matter testing. What is the FIRST action the pharmacy should take?
- Quarantine the entire batch and initiate an investigation (Correct answer)
- Discard only the vials that failed and release the rest
- Re-filter the batch through a 0.22-micron filter
- Notify the prescriber and continue dispensing
Correct answer: Quarantine the entire batch and initiate an investigation
The entire batch must be quarantined immediately to prevent patient harm while a root-cause investigation is conducted.
Question 3: What does the term 'process validation' mean in sterile compounding?
- Documented evidence that a process consistently produces a product meeting its specifications (Correct answer)
- A one-time check that equipment is functioning properly
- Verification that a compounding technician is competent
- Confirmation that raw materials meet USP standards
Correct answer: Documented evidence that a process consistently produces a product meeting its specifications
Process validation provides documented evidence that a compounding process consistently and reproducibly produces a product meeting its predetermined specifications.
Question 4: Per USP <797>, how often must surface sampling for microbial contamination be performed in an ISO 5 PEC during Category 2 compounding?
- Monthly (Correct answer)
- Every 6 months
- Annually
- Weekly
Correct answer: Monthly
USP <797> requires surface sampling in ISO 5 PECs used for Category 2 CSPs to be performed at least monthly.
Question 5: Which test method uses agar contact plates or swabs applied directly to equipment surfaces to detect microbial contamination?
- Surface sampling (Correct answer)
- Active air sampling
- Passive air sampling (settle plates)
- Volumetric air sampling
Correct answer: Surface sampling
Surface sampling uses contact plates (RODAC plates) or swabs directly on surfaces to quantify microbial contamination.
Question 6: A compounding pharmacy finds colony counts exceeding action levels during routine environmental monitoring. Which response is MOST appropriate?
- Cease compounding, perform enhanced cleaning, investigate the root cause, and re-sample before resuming (Correct answer)
- Increase the frequency of monitoring only and continue compounding
- Discard all CSPs in quarantine and resume compounding after wiping surfaces
- Document the exceedance and continue normal operations
Correct answer: Cease compounding, perform enhanced cleaning, investigate the root cause, and re-sample before resuming
Exceeding action levels requires halting compounding, performing enhanced disinfection, identifying the root cause, and confirming environmental control before resuming.
Question 7: What is the primary purpose of conducting a media-fill (process simulation) test in sterile compounding?
- To qualify the aseptic technique of compounding personnel and demonstrate that the process can produce sterile preparations (Correct answer)
- To test the potency of API raw materials
- To verify the sterility of the final product container
- To calibrate the laminar airflow workbench
Correct answer: To qualify the aseptic technique of compounding personnel and demonstrate that the process can produce sterile preparations
Media-fill tests simulate the actual compounding process using microbiological growth media to demonstrate that aseptic technique can produce sterile product.
CSPT Quality Control and Assurance 4
Which statistical method is used to determine if a compounding process is within acceptable limits by plotting data points over time?