CSPT Quality Assurance Protocols 4 — Questions and Answers
Question 1: Which parameter is most critical to monitor during a media fill (process simulation) test?
- Incubation temperature and duration (Correct answer)
- The color of the growth medium
- The weight of each filled container
- The number of technicians present
Correct answer: Incubation temperature and duration
Media fill vials must be incubated at specified temperatures (20–25°C and 30–35°C) for at least 14 days to allow microbial growth if contamination occurred.
Question 2: Under USP <797>, what action is required if a media fill unit shows turbidity after incubation?
- The batch is placed on quarantine and an investigation is initiated (Correct answer)
- The turbid unit is discarded and the batch is released
- The incubation is extended by 7 days
- The result is documented but no action is taken
Correct answer: The batch is placed on quarantine and an investigation is initiated
Any turbidity (evidence of microbial growth) in a media fill unit triggers a full investigation, quarantine, and potential re-qualification before returning to production.
Question 3: What is the primary purpose of endotoxin (LAL) testing in sterile compounding quality assurance?
- To detect bacterial pyrogens that could cause fever if injected (Correct answer)
- To confirm the correct pH of the finished preparation
- To verify that particulate matter is absent
- To measure the potency of the active pharmaceutical ingredient
Correct answer: To detect bacterial pyrogens that could cause fever if injected
The Limulus Amebocyte Lysate (LAL) test detects gram-negative bacterial endotoxins that are pyrogenic and can cause serious systemic reactions even in sterile solutions.
Question 4: A pharmacy uses a new lot of sterile vials and notices the filled preparations have a slightly cloudy appearance not present with the previous lot. What is the FIRST QA action to take?
- Quarantine the batch and perform particulate matter and compatibility investigations (Correct answer)
- Release the batch and monitor for patient complaints
- Add a chelating agent to clear the cloudiness
- Increase the filtration pressure during filling
Correct answer: Quarantine the batch and perform particulate matter and compatibility investigations
Unexpected cloudiness is a visual defect requiring quarantine and investigation for particulate contamination, incompatibility, or container leachables before any product is dispensed.
Question 5: Which of the following best describes a 'corrective and preventive action' (CAPA) in sterile compounding QA?
- A documented process to identify root causes of deviations and prevent recurrence (Correct answer)
- A checklist used during daily cleaning of the ISO 5 hood
- A log of all medications dispensed from the cleanroom
- A standard procedure for reconstituting lyophilized drugs
Correct answer: A documented process to identify root causes of deviations and prevent recurrence
CAPA is a quality management tool that investigates the root cause of a nonconformance (corrective) and implements system changes to prevent it from happening again (preventive).
Question 6: How often must air velocity and HEPA filter integrity (DOP/PAO testing) typically be verified in an ISO 5 primary engineering control per USP <797>?
- At least every 6 months (Correct answer)
- Every 2 years
- Only upon initial installation
- Quarterly (every 3 months)
Correct answer: At least every 6 months
USP <797> requires ISO 5 PECs to undergo HEPA filter integrity and airflow velocity testing at least every 6 months (and after any maintenance or relocation).
Question 7: What does a 'beyond-use date' (BUD) on a compounded sterile preparation represent?
- The date and time after which the preparation should not be used, based on sterility and stability data (Correct answer)
- The expiration date printed on the original manufacturer's vial
- The date the preparation was ordered by the physician
- The maximum shelf life regardless of storage conditions
Correct answer: The date and time after which the preparation should not be used, based on sterility and stability data
BUD is assigned based on sterility risk category, storage conditions, and available stability data, and represents the limit of safe use specific to the compounded product.
CSPT Quality Assurance Protocols 4
Which parameter is most critical to monitor during a media fill (process simulation) test?