Quality Assurance Protocols Flashcards

What is the role of an equipment preventive maintenance program?

Answer: To ensure all equipment operates within specifications through scheduled inspections, calibrations, and servicing

Preventive maintenance ensures all compounding equipment consistently operates within required specifications.

How should a pharmacy handle a failed sterility test result?

Answer: Immediately quarantine remaining units, initiate investigation, notify care teams, determine root cause, and implement corrective actions

A failed sterility test requires immediate quarantine, clinical notification, investigation, and corrective measures.

What is the purpose of sporicidal cleaning in a sterile compounding facility?

Answer: To kill bacterial spores that are resistant to standard disinfectants like 70% IPA

Sporicidal agents kill bacterial endospores that survive standard disinfection with 70% IPA.

What is the significance of viable versus non-viable environmental monitoring?

Answer: Non-viable counts total particles; viable specifically detects living microorganisms; both are needed

Non-viable monitoring measures total particles while viable monitoring detects living microorganisms. Both provide complementary information.

What should be included in a facility self-inspection program?

Answer: Comprehensive review of all quality system elements against USP 797 requirements

Self-inspection evaluates every aspect of the sterile compounding program against applicable standards.

What is the purpose of stability testing for compounded sterile preparations?

Answer: To establish scientifically supported beyond-use dates by determining how long a CSP maintains its quality

Stability testing provides the scientific basis for BUD assignment by measuring potency, purity, and physical characteristics over time.