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Quality Control Analytical Methods: Strategies to Ensure a Robust Quality-control Microbiology Program

Author(s):  Griffiths Tricia, Connors Anne

Issue:  Mar/Apr 2013 - Volume 17, Number 2
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Abstract:  As the regulatory environment for compounding pharmacies continues to evolve, facilities can take immediate steps to strengthen their quality-control microbiology and environmental monitoring programs. Robust programs that are timely, comprehensive, and effective will minimize risk and help support positive patient outcomes. This article provides a roadmap for putting in place a robust quality-control microbiology program in the face of United States Pharmacopeia Chapter <797> standards, and highlights several technologies for environmental monitoring that support a successful program.

Related Keywords: Tricia Griffiths, BA, Anne Connors, BS, United States Pharmacopeia Chapter <797>, USP, compounded sterile preparations, microbial contamination, microbiology control, quality testing, drug safety, environmental monitoring, contact plates, swabs, airborne contaminants, surface contaminants, settle plates, active air samplers, particle counters, microorganisms

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, INFECTIOUS DISEASE

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