PTCE Pharmacy Quality Assurance 3 — Questions and Answers
Question 1: Which USP chapter governs sterile compounding environmental quality standards, including ISO classifications?
- USP <795>
- USP <797> (Correct answer)
- USP <800>
- USP <1075>
Correct answer: USP <797>
USP <797> sets environmental monitoring requirements and ISO classification standards for sterile compounding facilities.
Question 2: An ISO Class 5 environment is required for which compounding activity?
- Non-sterile cream preparation
- Direct compounding of sterile preparations (Correct answer)
- Labeling of packaged medications
- Oral solid dosage form counting
Correct answer: Direct compounding of sterile preparations
ISO Class 5 (also called the Primary Engineering Control) is required for the actual preparation of CSPs to limit microbial and particulate contamination.
Question 3: Which action is the most appropriate response when a compounding technician discovers a significant calculation error after the CSP has been dispensed?
- Document the error quietly and continue working
- Notify the pharmacist immediately and initiate a recall if needed (Correct answer)
- Wait to see if the patient reports a problem
- Correct the log entry to reflect the right amount
Correct answer: Notify the pharmacist immediately and initiate a recall if needed
Immediate pharmacist notification and potential product recall is the correct response to protect patient safety after a dispensing error.
Question 4: What is the primary purpose of media-fill testing in a sterile compounding environment?
- To test for pyrogens in the final product
- To evaluate the aseptic technique of compounding personnel (Correct answer)
- To measure humidity in the cleanroom
- To verify container closure integrity
Correct answer: To evaluate the aseptic technique of compounding personnel
Media-fill testing uses microbiological growth media to simulate CSP preparation and assess whether personnel aseptic technique can prevent contamination.
Question 5: Environmental surface sampling in a sterile compounding area is performed primarily to:
- Assess employee hand hygiene compliance
- Monitor for microbial contamination on work surfaces (Correct answer)
- Measure temperature variations in the cleanroom
- Verify HEPA filter installation dates
Correct answer: Monitor for microbial contamination on work surfaces
Surface sampling detects microbial bioburden on compounding surfaces to ensure the environment remains within acceptable contamination limits.
Question 6: A pharmacy receives a complaint that a batch of compounded oral suspension tastes unusually bitter. What QA step should be initiated first?
- Discard all remaining product immediately
- Review batch records to identify potential ingredient or process errors (Correct answer)
- Reformulate the suspension immediately
- Contact the patient's prescriber for guidance
Correct answer: Review batch records to identify potential ingredient or process errors
Reviewing batch records is the first step to identify the root cause of the quality complaint before taking further corrective action.
Question 7: Which of the following is an acceptable garbing sequence when entering a cleanroom for sterile compounding?
- Gloves → shoe covers → gown → mask → hair cover
- Shoe covers → hair cover → mask → gown → gloves (Correct answer)
- Mask → gown → gloves → shoe covers → hair cover
- Gown → gloves → shoe covers → mask → hair cover
Correct answer: Shoe covers → hair cover → mask → gown → gloves
The correct garbing sequence (shoe covers first, gloves last) minimizes contamination risk by moving from lowest to highest cleanliness zones.
PTCE Pharmacy Quality Assurance 3
Which USP chapter governs sterile compounding environmental quality standards, including ISO classifications?