CSPT Quality Assurance Protocols 4

Question 1

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

Accepted Answer

Incubation temperature and duration

Answer

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?

Accepted Answer

The batch is placed on quarantine and an investigation is initiated

Answer

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?

Accepted Answer

To detect bacterial pyrogens that could cause fever if injected

Answer

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?

Accepted Answer

Quarantine the batch and perform particulate matter and compatibility investigations

Answer

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?

Accepted Answer

A documented process to identify root causes of deviations and prevent recurrence

Answer

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).

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Quality Assurance Protocols 4