Quality Control and Assurance Flashcards
7 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Control and Assurance flashcards as text
Which statistical method is used to determine if a compounding process is within acceptable limits by plotting data points over time?
Answer: Control chart (Shewhart chart)
Control charts (Shewhart charts) plot process data over time to detect trends or shifts that indicate the process is out of statistical control.
A batch of sterile compounded preparations fails particulate matter testing. What is the FIRST action the pharmacy should take?
Answer: Quarantine the entire batch and initiate an investigation
The entire batch must be quarantined immediately to prevent patient harm while a root-cause investigation is conducted.
What does the term 'process validation' mean in sterile compounding?
Answer: Documented evidence that a process consistently produces a product meeting its specifications
Process validation provides documented evidence that a compounding process consistently and reproducibly produces a product meeting its predetermined specifications.
Per USP , how often must surface sampling for microbial contamination be performed in an ISO 5 PEC during Category 2 compounding?
Answer: Monthly
USP requires surface sampling in ISO 5 PECs used for Category 2 CSPs to be performed at least monthly.
Which test method uses agar contact plates or swabs applied directly to equipment surfaces to detect microbial contamination?
Answer: Surface sampling
Surface sampling uses contact plates (RODAC plates) or swabs directly on surfaces to quantify microbial contamination.
A compounding pharmacy finds colony counts exceeding action levels during routine environmental monitoring. Which response is MOST appropriate?
Answer: Cease compounding, perform enhanced cleaning, investigate the root cause, and re-sample before resuming
Exceeding action levels requires halting compounding, performing enhanced disinfection, identifying the root cause, and confirming environmental control before resuming.
What is the primary purpose of conducting a media-fill (process simulation) test in sterile compounding?
Answer: To qualify the aseptic technique of compounding personnel and demonstrate that the process can produce sterile preparations
Media-fill tests simulate the actual compounding process using microbiological growth media to demonstrate that aseptic technique can produce sterile product.