Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy
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Abstract: Undeniably, one of the most important considerations in a compounding pharmacy’s procedures is quality. Developing a comprehensive quality-control potency program must begin with the most basic activities performed at a compounding pharmacy to the most crucial activities. If the basics are not met, the crucial activities of compounding sterile and non-sterile preparations and the quality of the end product are in jeopardy. Basic definitions are provided in this article as well as a discussion on a three-step method on setting up a quality-control potency testing program, to include (1) process design and how to reduce the potential of variations and mistakes in compounded preparations, (2) process verification, and (3) how to set up a sampling plan to monitor ongoing quality. Also included are suggestions on how to get started on the development of a quality-control potency testing program.
Related Keywords:
William J. Zolner, PhD, quality control, quality assurance, potency testing, compounding mistakes, process design, sampling plan
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