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Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmacy Compounding Sterile Preparations, Part 17: Elements of Quality Control

Author(s):  Okeke Claudia C, Allen Loyd V Jr

Issue:  Jan/Feb 2010 - Pediatrics and Wellness
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Abstract:  To ensure the quality of compounded preparations, an efficient quality-assurance program is necessary. This article clearly defines the elements necessary to establish a quality-assurance program that meets the standards set forth in the United States Pharmacopeia in the area of personnel training. It is essential that compounders have knowledge of the substances used in compounding and the devices used in the compounding facility. Specific and continuous training is essential to provide the compounder with the necessary knowledge to get the job completed. Knowledge of basic science principles is necessary to enable the compounder to understand and interpret scientific data and reports provided by the suppliers. In addition, handling and manipulating the equipment requires specific training to ensure that the results generated by the equipment are correct and accurate.

Related Keywords: Claudia C Okeke, PhD, Loyd V Allen, Jr., PhD, RPh, United States Pharmacopeia Chapter <797>, USP standards, environmental control, quality assurance, employee training, sterile compounding, equipment, ingredients

Related Categories: ENVIRONMENTAL , SOPs, STERILE PREPARATIONS, QUALITY CONTROL, PHARMACY EDUCATION, UNITED STATES PHARMACOPEIA CONVENTIONS

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