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Abstract:  Although many areas in the health-care delivery system are well managed or have externally defined practice standards providing a mandate for the delivery of consistent patient care, sterile-product compounding has been overlooked. In this article, the authors discuss historical context, current status, interim standards: United States Pharmacopeia guidelines, components of systematic process controls for sterile-product operations (data, proactive employee management, process simulation testing and monitoring the cleanroom) and putting it all together. The authors conclude that service organizations structured in a systematic manner greatly reduce management by opinion and allow for management by fact. Systematic process control generates the necessary data to provide consistent patient care; services; and, ultimately, customer satisfaction, in addition to other benefits.

Related Keywords: aseptic technique, cleanroom, proactive employee management, product consistency, product quality, SOPs, standards of practice, sterilization, systematic process control

Related Categories: BUSINESS, STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS

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