Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1.

ABSTRACT

Compounders engaged in making sterile preparations need to employ a quality assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility's quality control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U.S. Food and Drug Administration. In part 1 of this 2-part article, we discuss the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 will examine the United States Pharmacopeia's discussion on the principles of quality assurance and quality control in sterile compounding.