By Eden M. Venti, ASQ CQA

Facilities that prepare, store, and dispense compounded sterile preparations (CSPs) are responsible for ensuring continued compliance with USP Chapter <797> through a series of in-process and finished-process quality checks. Appropriate quality checks will ensure preparations are consistently compounded correctly. In addition, risk assessments should be performed prior to the release of a medication. Risk assessments will ensure that all of the variables (materials, people, environment, methods, intended use, etc.) surrounding the preparation, in addition to performed and recorded quality checks, are taken into consideration prior to the finished preparation’s release.

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