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Abstract:  Per United States Pharmacopeia Chapter <797>, effective November 1, 2023, uncovering non-conforming cleanroom microbiological conditions must be investigated thoroughly and in a timely manner. This article’s objective is to outline the basic elements in investigating microbiological excursions at a sterile compounding facility, which models the use of an Ishakawa diagram to conduct a root cause investigation and discusses important concepts such as: product impact analysis, corrective and preventive action effectiveness checks, trend analysis, and investigational pitfalls to avoid. While this article focuses on investigating microbiological excursions, the concepts can be applied to investigating an out-of-range temperature, relative humidity, pressure differential, total particle count, or compounded sterile preparation failure.

Related Keywords: Amy Summers, PharmD, BCSCP, microbiological excursions, sterile compounding facilities, United States Pharmacopeia Chapter <797>, USP, cleanroom, Ishakawa diagram, environmental investigations, investigative methods, root cause investigations, compounding personnel, cleanroom processes, cleanroom equipment, engineering controls, cleanroom materials and supplies, microorganism identification, aseptic technique, compounded sterile preparations, environment, product impact analysis, corrective and preventive actions, CAPA plan effectiveness checks, remediation, investigation pitfalls

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, INFORMATION RESOURCES

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