How to Develop a Quality Compliance Program for 795/797

The Designated Person identified in the USP compounding chapters has responsibility for establishing a Quality Plan that includes adherence to policies and procedures, prevention and detection of adverse events, and corrective actions that must be taken when concerns are identified. This program will review development and maintenance of the Quality Control and Quality Assurance program required by USP <797>, including identification of elements that can be included in a sustainable plan.