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Quality-Control Analytical Methods: Minimizing the Probability of Out-of-Specification Preparations: Results that Make You Say…Hmmm!

Author(s):  Odegard Russell D

Issue:  Mar/Apr 2008 - Compounding Around the World
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Abstract:  To prevent compounding of an out-of-specification preparation, the possible causes of such an error must be identified and eliminated. Implementation of simple practices can decrease the probability of errors, resulting in a safer situation for both the patient and the pharmacy. The United States Pharmacopeia–National Formulary is the standard-setting reference for compounding procedures; all compounding pharmacists should read and adhere to those standards. This article discusses these standards as they relate to drug potency, sterility, endotoxin, and particulate matter results.

Related Keywords: Russell D. Odegard, MBA, BSc, quality control, quality assurance, out of specification preparation, potency, concentration, United States Pharmacopeia, USP standards, sterile preparations, endotoxin, particulates


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