Quality Assurance in Pharmacy Compounding

Quality Control Procedures

Quality assurance in compounding ensures that every preparation meets required standards for potency, purity, and sterility. Key quality control measures include ingredient verification, weight checks, visual inspection, pH testing, and end-product testing when required.

For sterile preparations, environmental monitoring includes viable and nonviable air sampling, surface sampling, and personnel competency testing (media fill tests and gloved fingertip sampling). These tests verify that the clean room environment and personnel technique maintain sterility.

Documentation Requirements

Every compounded preparation requires a master formulation record (the recipe) and a compounding record (the log of each individual batch). The compounding record must include the date, formula used, ingredients with lot numbers and expiration dates, quantity prepared, assigned BUD, and the identity of personnel involved.

Standard operating procedures (SOPs) must be written and followed for all compounding activities. Personnel must be trained initially and demonstrate ongoing competency through regular assessments.

Exam Preparation

Quality assurance knowledge is valuable for the PTCB exam. Study with flashcards and test yourself with mini exams.