Quality Control and Assurance Flashcards
6 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 6 Quality Control and Assurance flashcards as text
What is the purpose of trending environmental monitoring data over time?
Answer: To identify gradual changes or patterns indicating developing problems before action levels are exceeded
Trending detects gradual increases that may indicate deteriorating conditions, enabling proactive intervention.
What competency assessments are required for sterile compounding personnel?
Answer: Media-fill testing, written assessment, didactic training, and direct observation of aseptic technique
USP 797 requires a comprehensive multi-faceted competency assessment program.
What is the significance of surface sampling in environmental monitoring?
Answer: It detects microbial contamination on surfaces, indicating cleaning effectiveness and contamination risks
Surface sampling provides direct evidence of cleaning effectiveness and identifies potential contamination sources.
Why is pharmacist verification of the final CSP a critical quality control step?
Answer: The pharmacist performs an independent check of ingredients, quantities, technique, labeling, and appearance
Pharmacist verification provides an independent expert review of the entire compounding process.
What is a quality event and how should it be managed?
Answer: Any occurrence deviating from quality standards, requiring documentation, investigation, root cause analysis, and corrective action
Quality events include errors, near-misses, environmental excursions, equipment failures, and complaints.
What is the role of an annual quality management review?
Answer: To comprehensively evaluate all quality indicators, trending data, CAPA effectiveness, and compliance
The annual review evaluates the overall quality program to identify strengths, weaknesses, and improvement opportunities.
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