When the U.S. Food and Drug Administration (FDA), under the leadership of Ajaz Hussain, then the Associate Director of the FDA’s Center for Drug Evaluation and Research (CDER), launched the Process Analytical Technology (PAT) Initiative a decade ago, it set in motion a multifaceted search for a more scientifically based approach to pharmaceutical manufacturing and quality assurance. Hussain’s call for more PAT in the industry’s manufacturing operations was really more of a challenge to current practices than a proscriptive program. The pharmaceutical industry has responded with a renewed emphasis on understanding the scientific basis of its processes, and toward that end has made significant investments in personnel and tools.
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