International journal of pharmaceutical compounding
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Process analytical technology was introduced by the U. S. Food and Drug Administration about 20 years ago to assist the pharmaceutical industry in making changes that should reduce batch failures, ensure performance, and enhance quality. ⋯ The purpose of this article is simply to introduce the concept of process analytical technology into compounding with the understanding that it will take a number of years for it to be evaluated and implemented, even on a small scale. It is not feasible to do it all at once; just one step at a time. Since patient safety is uppermost in compounding, this concept should be considered.