Quality Assurance Protocols Flashcards

Which environmental monitoring method uses settle plates exposed to room air to assess viable microbial contamination?

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.

A sterile compounding facility finds mold on a surface sample taken inside the ISO 7 buffer area. According to USP , what is the MOST appropriate immediate response?

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.

In sterile compounding QA, what is the purpose of a 'lot-specific certificate of analysis' (COA) for a bulk active pharmaceutical ingredient?

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.

What is the significance of establishing action levels (vs. alert levels) in environmental monitoring programs?

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.

Which sterility testing method exposes the entire sample volume to culture media by filtering it through a membrane?

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.

Under a robust QA program, which document formally authorizes the release of a compounded sterile preparation batch for dispensing?

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.

A compounding pharmacy discovers during a retrospective audit that BUDs were assigned without supporting stability data. Which USP concept was violated?

Answer: The requirement that BUDs be based on chemical stability, sterility, and storage conditions supported by literature or testing

USP requires that BUDs reflect actual chemical and physical stability data from recognized references or validated studies, not arbitrary time limits.