USP 797 Tip: Spread out Employee Competencies for Early Warning System

I liked this suggestion given by Eric Kastango in Pharmacy Purchasing & Products magazine’s Cleanrooms & Compounding supplemental issue in 2009:

The activities associated with hand hygiene, media fill, surface sampling, and gloved fingertip sampling are often misunderstood. The purpose of these quality elements is to demonstrate proper aseptic technique for compounding personnel…

Once all compounding and supervisory personnel—including pharmacists and technicians—have completed their initial training (regardless of their previous experience), these elements can be integrated into each employee’s annual or semi-annual training. It may be best to validate the competency of a few employees each month, avoiding a mass staff competency verification performed once a year. By dividing staff and performing these activities on a monthly basis, this process will also provide a baseline of microbial bioburden data for the controlled work areas. These data can serve as an early warning system to prevent processes, personnel, and/or facility operations from migrating out of a state of control.

By spreading media fill, glovetip, and surface sample competencies through the year, not only do you avoid the stress of doing them all at once, but perhaps more importantly you will know as soon as results are starting to creep out of range rather than waiting until the 6-month certification.


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