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Quality Control Analytical Methods: Method Validation

Author(s):  Klang Mark G,Williams LaVonn A

Issue:  Sep/Oct 2016 - Volume 20, Number 5
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Abstract:  To properly determine the accuracy of a pharmaceutical product or compounded preparation, tests must be designed specifically for that evaluation. The procedures selected must be verified through a process referred to as method validation, an integral part of any good analytical practice. The results from a method validation procedure can be used to judge the quality, reliability, and consistency of analytical results. The purpose of this article is to deliver the message of the importance of validation of a pharmaceutical product or compounded preparation and to briefly discuss the results of a lack of such validation.

Related Keywords: Mark G. Klang, MS, RPh,BCNSP, PhD, LaVonn A. Williams, analytical procedures, quality assurance, United States Pharmacopeia Chapter <1163>, USP, analytic assay, analytical method validation, International Conference on Harmonisation, reference standards, quality control, data quality, system suitability tests, analytical instrument qualification, patient safety

Related Categories: STABILITIES, COMPATIBILITIES, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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