A Process Verification Model for Quality Assurance in a Compounding Pharmacy
Author(s): Zolner William J
Issue: May/Jun 2008 - Pain Management
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Page(s): 247-251
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Abstract: There are virtually thousands of examples of uses of the “process” model of quality assurance in modern industrial applications, so the precedent for this type of quality-assurance and quality-control program is well established and thoroughly accepted. The initiation of a process verification model for quality assurance and control, and the documentation involved in the process, constitute appropriate proof that a compounding pharmacy is developing quality preparations, which in turn can be used to improve a pharmacy’s operation.
Related Keywords: William J. Zolner, PhD, quality control analytic methods, quality assurance, process verification model, product testing, U.S. Food and Drug Administration, FDA, standard operating procedures, sterile preparations