Pharmacy Quality Assurance Flashcards
7 cards from real PTCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacy Quality Assurance flashcards as text
Which USP chapter governs sterile compounding environmental quality standards, including ISO classifications?
Answer: USP
USP sets environmental monitoring requirements and ISO classification standards for sterile compounding facilities.
An ISO Class 5 environment is required for which compounding activity?
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.
Which action is the most appropriate response when a compounding technician discovers a significant calculation error after the CSP has been dispensed?
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.
What is the primary purpose of media-fill testing in a sterile compounding environment?
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.
Environmental surface sampling in a sterile compounding area is performed primarily to:
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.
A pharmacy receives a complaint that a batch of compounded oral suspension tastes unusually bitter. What QA step should be initiated first?
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.
Which of the following is an acceptable garbing sequence when entering a cleanroom for sterile compounding?
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.