CSPT Quality Control and Assurance 5 — Questions and Answers
Question 1: Which document provides a step-by-step written procedure that ensures consistency in how a compounding process is performed each time?
- Standard operating procedure (SOP) (Correct answer)
- Master formulation record (MFR)
- Compounding record (CR)
- Certificate of analysis (CoA)
Correct answer: Standard operating procedure (SOP)
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?
- Out of specification (Correct answer)
- Out of service
- Order of sterilization
- Operational oversight system
Correct answer: Out of specification
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?
- Endotoxin and sterility test results (Correct answer)
- Color and odor description only
- Retest date and warehouse location
- Supplier's internal batch number only
Correct answer: Endotoxin and sterility test results
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?
- The positive pressure cascade may be compromised, potentially allowing contamination to enter the cleanroom (Correct answer)
- The HEPA filters need to be replaced immediately
- The room temperature is too high
- The pass-through chamber is blocked
Correct answer: The positive pressure cascade may be compromised, potentially allowing contamination to enter the cleanroom
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?
- The needle tip and the opening of a vial after removal of the stopper (Correct answer)
- The outer surface of the final bag label
- The outside of a sealed ampule before scoring
- The surface of the laminar airflow workbench prefilter
Correct answer: The needle tip and the opening of a vial after removal of the stopper
Critical sites are any openings or junctions that provide a direct pathway into the sterile preparation, including needle tips, vial stoppers, and injection ports.
Question 6: What is the purpose of the 'first air' concept in a laminar airflow workbench (LAFW)?
- Critical items must be placed so that HEPA-filtered air reaches them before passing over any other object to prevent contamination (Correct answer)
- Air from outside the hood must be filtered first before entering the workspace
- The first air change of the day must run for 30 minutes before use
- All compounding must begin at the front of the hood first
Correct answer: Critical items must be placed so that HEPA-filtered air reaches them before passing over any other object to prevent contamination
First air is the uninterrupted HEPA-filtered air that flows directly from the filter to critical sites without passing over any obstacles that could cause turbulence or contamination.
Question 7: Which quality indicator would BEST demonstrate that a sterile compounding pharmacy's cleaning and disinfection program is effective?
- Consistently passing microbial surface and air sampling results within action levels over time (Correct answer)
- Having written SOPs for cleaning procedures posted in the cleanroom
- Using only EPA-registered disinfectants on all surfaces
- Training all personnel on the cleaning schedule annually
Correct answer: Consistently passing microbial surface and air sampling results within action levels over time
Environmental monitoring data (surface and air sampling results) are the objective evidence that the cleaning program is actually achieving microbial control.
CSPT Quality Control and Assurance 5
Which document provides a step-by-step written procedure that ensures consistency in how a compounding process is performed each time?