Which term refers to the system of procedures and oversight ensuring the compounding process consistently meets quality standards?

• A. Quality Control
• B. Quality Assurance
• C. Validation
• D. Verification

Answer: (B)

Quality Assurance is the overarching system of procedures and oversight that ensures the entire compounding workflow consistently meets quality standards. It sets up and maintains the framework—SOPs, training, document control, change control, internal audits, CAPA, deviation management, and supplier qualification—that prevents quality problems by designing processes correctly and monitoring them continuously. In compounding, QA covers the whole quality management system from aseptic technique procedures to batch records and environmental monitoring, making sure every batch is produced to specification.

Quality Control, by comparison, concentrates on testing the product to detect defects after production. Validation is about proving that a process or method reliably yields results that meet predefined criteria under specified conditions. Verification involves confirming that a process or product fulfills its stated requirements at particular stages.