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Performance Qualification of HPLC Instrumentation in Regulated Laboratories
The generation of high-quality, reliable analytical data is grounded on three fundamental components: instrument qualification, method validation, and user training (1,2). For the pharmaceutical industry, these activities fall under cGMP/GLP regulations. Although the specific regulations can vary for the environmental or other industries, the principles remain the same.
The first of these, instrument qualification, is the focus of this article. A laboratory plan for analytical instrument qualification (AIQ) is a requirement for all cGMP/GLP laboratories. The pending USP guidance document <1058> (3) reflects the evolving accepted practices for the introduction and qualification of analytical instrumentation into the regulated laboratory environment.
Journal:
LCGC North America, May 2008
Copyright:
© Advanstar Communications, Inc. All rights reserved.
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