CSPT Quality Assurance Protocols 5 — Questions and Answers
Question 1: Which environmental monitoring method uses settle plates exposed to room air to assess viable microbial contamination?
- Passive air sampling (Correct answer)
- Active air sampling
- Surface contact plate sampling
- Glove fingertip sampling
Correct answer: Passive air sampling
Settle plates (passive air sampling) are petri dishes with agar left open for a set time to allow airborne microorganisms to settle and grow, providing a qualitative measure of bioburden.
Question 2: A sterile compounding facility finds mold on a surface sample taken inside the ISO 7 buffer area. According to USP <797>, what is the MOST appropriate immediate response?
- Cease compounding, perform thorough disinfection with a sporicidal agent, and re-sample before resuming (Correct answer)
- Continue compounding while scheduling a cleaning for after hours
- Wipe the area with 70% IPA and resume normal operations
- Notify the board of pharmacy and await their instructions before doing anything
Correct answer: Cease compounding, perform thorough disinfection with a sporicidal agent, and re-sample before resuming
Mold (fungal contamination) in the buffer area requires immediate cessation of compounding, sporicidal disinfection (since IPA is not sporicidal), and verification re-sampling before resuming.
Question 3: In sterile compounding QA, what is the purpose of a 'lot-specific certificate of analysis' (COA) for a bulk active pharmaceutical ingredient?
- To verify that the specific lot meets identity, potency, purity, and quality specifications (Correct answer)
- To confirm the ingredient was purchased from a licensed supplier
- To document the quantity of ingredient used in each batch
- To replace the need for in-house testing of the ingredient
Correct answer: To verify that the specific lot meets identity, potency, purity, and quality specifications
A lot-specific COA provides analytical test results (identity, assay, impurities, microbial limits) for that exact lot, confirming it meets specifications before use in compounding.
Question 4: What is the significance of establishing action levels (vs. alert levels) in environmental monitoring programs?
- Action levels require mandatory investigation and corrective action, while alert levels signal a trend requiring increased vigilance (Correct answer)
- Action levels are set lower than alert levels to provide an early warning
- Alert levels require the facility to shut down, while action levels only require documentation
- Action and alert levels are interchangeable terms with no practical difference
Correct answer: Action levels require mandatory investigation and corrective action, while alert levels signal a trend requiring increased vigilance
Alert levels indicate a potential drift from normal conditions and prompt review, whereas action levels mandate immediate investigation, corrective action, and documentation to prevent patient harm.
Question 5: Which sterility testing method exposes the entire sample volume to culture media by filtering it through a membrane?
- Membrane filtration method (Correct answer)
- Direct inoculation method
- LAL gel-clot method
- Turbidity assay
Correct answer: Membrane filtration method
The membrane filtration method passes the entire preparation through a 0.45 µm membrane that retains microorganisms, which are then incubated in culture media, making it suitable for large-volume preparations.
Question 6: Under a robust QA program, which document formally authorizes the release of a compounded sterile preparation batch for dispensing?
- A batch record reviewed and signed by a pharmacist verifying all quality checks were met (Correct answer)
- The original physician prescription
- A verbal confirmation from the compounding technician
- The packing slip from the ingredient supplier
Correct answer: A batch record reviewed and signed by a pharmacist verifying all quality checks were met
Batch release requires a pharmacist to review the completed batch record confirming ingredient identity, quantities, process parameters, and QC test results before the preparation is dispensed.
Question 7: A compounding pharmacy discovers during a retrospective audit that BUDs were assigned without supporting stability data. Which USP <797> concept was violated?
- The requirement that BUDs be based on chemical stability, sterility, and storage conditions supported by literature or testing (Correct answer)
- The rule that all preparations must undergo sterility testing before release
- The guideline mandating active air sampling every 6 months
- The requirement to perform fingertip sampling after each garbing event
Correct answer: The requirement that BUDs be based on chemical stability, sterility, and storage conditions supported by literature or testing
USP <797> requires that BUDs reflect actual chemical and physical stability data from recognized references or validated studies, not arbitrary time limits.
CSPT Quality Assurance Protocols 5
Which environmental monitoring method uses settle plates exposed to room air to assess viable microbial contamination?