Quality Assurance Protocols Flashcards

Which parameter is most critical to monitor during a media fill (process simulation) test?

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.

Under USP , what action is required if a media fill unit shows turbidity after incubation?

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.

What is the primary purpose of endotoxin (LAL) testing in sterile compounding quality assurance?

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.

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?

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.

Which of the following best describes a 'corrective and preventive action' (CAPA) in sterile compounding QA?

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).

How often must air velocity and HEPA filter integrity (DOP/PAO testing) typically be verified in an ISO 5 primary engineering control per USP ?

Answer: At least every 6 months

USP requires ISO 5 PECs to undergo HEPA filter integrity and airflow velocity testing at least every 6 months (and after any maintenance or relocation).

What does a 'beyond-use date' (BUD) on a compounded sterile preparation represent?

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.