Designated Persons in USP 795, 797, 800, and 825
The United States Pharmacopeia requires each facility to have a designated person for chapters 795, 797, 800, and 825. This role is vital to maintaining a facility's adherence to quality standards.
The designated person, or persons, may be designated for more than a single site and does not have to be a pharmacist or in an administrative position. This allows for a diverse range of personnel to take on this responsibility.
Designated Person Responsibilities include, but not limited to:
· Quality Assurance and Quality Control Programs
· Personnel Training and Evaluations
· Personal Hygiene and Garbing
· Facilities and Engineering Controls
· Environmental Quality and Control
· Microbiological Air and Surface Monitoring
· Equipment, Supplies, and Components
· Compounding
· Sterilization Methods
· Establishing Beyond Use Dates
· Complaints and Adverse Reporting
· Develop, Monitor, and Review Standard Operating Procedures
· Corrective Actions
· Documentation
· Drug Product Handling and Storage
· Drug Product Quality
· Ensure Compliance with the Chapter
American Society of Health-System Pharmacists provides a resource document charting designated person(s) responsibility assignment and chapter applicability. Click here to access.
ARL provides resource documents for:
· Personnel Qualification and Environmental Monitoring
· Drug Product Quality Tests for Sterile and Non-Sterile
· USP 800 Surface Wipe Sampling
· Establishing Beyond Use Dates
Each facility should subscribe to the United States Pharmacopeia Compounding Compendium and refer to its state board of pharmacy guidelines and accreditation entities for additional designated personnel requirements.
To request a quote for testing services to support your facility’s compliance with quality standards, contact info@arlok.com or 800-393-1595.
Resources:
· United States Pharmacopeia Compounding Compendium
· Fourth Annual USP Compounding Workshop – September 25-26, 2024
· American Society of Health-System Pharmacists Compounding Resource Center