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Quality Control and Basics of Sterile Compounding: Attempting to Avoid Out-of-Specification Results and Patient Harm in Sterile Compounding

Author(s):  Martin Matt

Issue:  Jan/Feb 2019 - Volume 23, Number 1
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Abstract:  What do you do when something goes wrong in your cleanroom? What do you do when a sterility test fails and what are the implications of such a failure? What should you do when your environmental monitoring or personnel monitoring provides results that exceed your action levels? A root cause analysis is needed in any situation where action levels are exceeded or tests are out of specification. However, should the questions be what can be done to prevent these occurrences, and how can the development be noticed before they occur? In this article, we will discuss going beyond the recommendations of United States Pharmacopeia Chapter <797> to attempt to build a program that limits the possibility of contamination through monitoring of the facility, personnel, and procedures in aseptic processing. We will also discuss other resources published by the U.S. Food and Drug Administration that address monitoring of sterile compounding and aseptic processing.

Related Keywords: Matt Martin, PharmD, out of specification results, root cause analysis, sterile compounding, United States Pharmacopeia Chapter <797>, USP, U.S. Food and Drug Administration, FDA, pharmacy inspection, Guidance for Industry, GFI, drug contamination, Current Good Manufacturing Practice, CGMP, sterility testing, environmental monitoring, aseptic processing, gloving, gowning, surface sampling, air sampling, compounded sterile preparation

Related Categories: ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, ADVERSE DRUG EVENTS

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