One of the most important factors for compliance with USP 797 is a reliable system to track its many facets. These standards include employee training programs with ongoing competency evaluations, environmental testing logs, quality assurance programs, and documentation of activities related to compounded sterile preparations (CSPs).
USP Chapters numbered between <1> and <999> are considered to be requirements and official standards of the USP. Pharmacies are subject to inspection against these standards by the FDA, state pharmacy boards, as well as independent accrediting organizations such as The Joint Commission. Given recent publicity surrounding compounding pharmacies, there is increased scrutiny on CSP quality outcomes and greater oversight of compounding processes. Such oversight encourages pharmacies and other compounding locations to diligently follow all of the relevant USP 797 guidelines.
One of the best solutions for ensuring USP 797 compliance is to use web-based tools that streamline compliance management tasks, documentation requirements and staff competency assessments and show all of this activity in turnkey dashboards. This type of solution allows pharmacies and other CSP preparation sites to attain and maintain a state of control. A strong quality management solution should include:
- A set of expert-based policies and procedures.
- A reference library that provides up-to-date information on techniques, policies and other key compliance facts.
- The capability to maintain and standardize documents electronically to eliminate paper records for organizations.
- Customization capabilities for the facility for the provision of surveillance activities, benchmarking, and quality systems review.
- Continuously updated information to remain compliant with any and all changes in USP 797 guidelines, procedures and policies.
- Access to ACPE-approved online continuing education that includes videos and interactive experiences.
- Ability to track all training, schedules and tasks, including notification of overdue items, exceptions and out-of-range measurements.
- Staff competency tests based on best-practice analysis and note annual test due dates for each employee.
- Ability to manage Master Formulation and Compounding Records in a centralized location.
- Access to robust analytics and dashboards to streamline inspections.
Often times, USP Chapters provide the guidelines on what to do to maintain compliance, but not how to do it. Rely on a quality management solution that helps you maintain compliance with USP 795, 797 and 800. Rely on Simplifi 797.