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Basics of Compounding for Sterile, Nonsterile, and Quality Control Compounding: Process Analytical Technology: Appropriate for Sterile and Nonsterile Compounding?

Author(s):  Allen Loyd V Jr

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Abstract:  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. Its premise is that “quality cannot be tested into preparations; it must be built-in or should be by design.” One proposed advantage was to reduce end-product testing by ensuring each process was functioning properly. In compounding, there are a number of processes that could be advantageously incorporated into process analytical technology since end-product testing is not generally done due to the nature of compounding. 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.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, process analytical technology, quality assurance, quality control, US Food and Drug Administration, FDA, sterile compounding, compounded sterile preparations, physical stability, chemical stability, contamination, consistency, scale up processes, risk assessment, hazards, preparation design, production design, continual quality improvement


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