CSPT Quality Control and Assurance 5

Question 1

Which document provides a step-by-step written procedure that ensures consistency in how a compounding process is performed each time?

Accepted Answer

Standard operating procedure (SOP)

Answer

SOPs provide detailed, standardized instructions for performing specific tasks, ensuring consistency and compliance across all personnel.

Question 2

What does OOS stand for in the context of pharmaceutical quality control?

Accepted Answer

Out of specification

Answer

OOS refers to 'out of specification,' meaning a test result falls outside the predetermined acceptance criteria established for that product.

Question 3

When reviewing a certificate of analysis (CoA) from a raw material supplier, which piece of information is MOST critical for verifying sterile compounding suitability?

Accepted Answer

Endotoxin and sterility test results

Answer

Endotoxin and sterility test results are critical because raw materials used in sterile compounding must be free of microbial contamination and pyrogens.

Question 4

A technician notices that the pressure differential between the buffer room and anteroom is not within specification. What does this indicate?

Accepted Answer

The positive pressure cascade may be compromised, potentially allowing contamination to enter the cleanroom

Answer

Proper pressure differentials maintain a positive pressure cascade that prevents less-clean air from entering cleaner zones; deviations indicate potential contamination risk.

Question 5

Which of the following represents a 'critical site' in sterile compounding that must be protected from contamination?

Accepted Answer

The needle tip and the opening of a vial after removal of the stopper

Answer

Critical sites are any openings or junctions that provide a direct pathway into the sterile preparation, including needle tips, vial stoppers, and injection ports.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Quality Control and Assurance 5