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Quality-Control Analytical Methods: Microbial Testing Aspects of USP <797> for Compounded Sterile Preparations

Author(s):  Kupiec Thomas C

Issue:  Jan/Feb 2005 - Sterile Preparations
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Abstract:  Both in principle and to comply with the new United States Pharmacopeia (USP) Chapter <797> standards for sterile compounding, compounding pharmacists must ensure the strength, quality, identify, and purity of the compounds they prepare. An outside analytical laboratory can assist by providing quality control and quality assurance. Quality-control testing should include, but is not limited to, sterility and endotoxin or pyrogen tests to ensure a microbe-free preparation. The key to quality control is to develop a protocol that is appropriate, logical, and well thought out for each compounding process. Tragedies resulting from poor quality control in compounding pharmacies can be prevented if pharmacies take a proactive role in quality control and quality assurance.

Related Keywords: Thomas C. Kupiec, PhD, United States Pharmacopeia, USP Chapter <797>, sterility testing, pyrogen testing, contract laboratories, quality assurance, microbes


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