(4) CPhT Exam Review: Pharmacy Quality Assurance

Quality Assurance correct answer: - Establishes systems for ensuring the quality of the product - Is established by the QA department to ensure that quality procedures are developed for the company - Guided by standard operating procedures - Monitored through audits Quality Control correct answer: - Uses the application of total quality management (TQM) and quality improvement - Follows standard operating procedures directed toward assuring the quality, purity, and effectiveness of the drug - Uses good manufacturing practices (GMPs) - Involves the day-to-day control of quality - Control of packaging to include materials used - Includes storage conditions of the product - Labeling must be 100% correct before product is dispensed Organizations Promoting QA correct answer: - U.S. Pharmacopeia - Food and Drug Administration (FDA) - The Joint Commission (TJC) - Institute of Safe Medication Practices (ISMP) - American Pharmacists Association (APhA) - American Society of Health-System Pharmacists - Accrediting Council of Pharmacy Education (ACPE) - State Boards of Pharmacy (BOPs) - National Association of Boards of Pharmacy (NABP) - Occupation Safety and Health Administration (OSHA) United States Phamacopeia correct answer: - Sets standards for ID, strength, quality, and purity of meds, foods, food ingredients, and dietary supplements - Publishes the United States Pharmacopeia and National Formulary (USP-NF); contains standards for chem and bio drug subs, dosage forms, compounded preps, excipient, medical devices, and dietary supplements - Drugs marketed must conform to USP-NF standards - Establishes sterile compounding reqs under USP <797> to include infection control - Establishes nonsterile compounding reqs under <795> - Standards established limit adulterants and contaminants that may be found in dietary drug supplements - Establishes reqs for labeling of meds, whether they're multidose vial or unit-dose container, an IV admixture, or a compound Food and Drug Administration (FDA) correct answer: - Oversees food, drugs, medical devices, vaccines, blood, biologics, veterinary, cosmetics, radiation-emitting products, and tobacco - Devleoped policies on biotech and provides info on dietary supplements - Addresses bioterrorism, drug preparedness, and natural disaster response during emergencies - Provides info on recent drug approvals and drug shortages; provides drug safety info - Established clinical trials, submission of drug applications, and req labeling of meds - Issues warning letters to public regarding specific meds an