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Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests

Author(s):  Kupiec Thomas C

Issue:  Sep/Oct 2007 - Veterinary Compounding
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Abstract:  It is apparent that the quality assurance program of a compounding pharmacy cannot adhere to the strict requirements of some of the general chapters in the United States Pharmacopeia. Those chapters containing such strict requirements that may impact pharmacy compounding should be studied thoroughly by the appropriate United States Pharmacopeia expert committee. Afterward, a determination should be made of which standards are reasonable and which can be modified and implemented to ensure timely preparation of quality compounded medications.

Related Keywords: Thomas C. Kupiec, PhD, quality control, United States Pharmacopeia, USP Chapter <71>, sterility tests, sterile preparations, standards, quality assurance, microbial contamination

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

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