Process Analytical Technology: Real-Time Reliability

Although the pharmaceutical industry has pioneered information technology as a research and development tool, it has consistently lagged behind other industries in using technology to automate and streamline manufacturing processes. Although in some cases, massive investments in drug discovery technology have yielded successful new products, inefficient production processes have prevented companies from meeting market demands quickly and cost effectively.

As the US Food and Drug Administration's Center for Drug Evaluation and Research has observed, "While Americans have the highest quality of drugs in the world, the process used to produce them can be expensive and wasteful" (1). Government and industry initiatives addressing this problem attribute much of that inefficiency to limited automation and point to manual recordkeeping and information collection as major contributors leading to the industry's poor manufacturing-efficiency record. Meanwhile, the pharmaceutical industry accepts equipment use rates that hover below 40%, a figure no other major industry tolerates, and batch quality failures range from 5 to 15%. With batches worth as much as $1 million apiece, these failures add up to significant loses. By comparison, the semiconductor market, which dealt with similar process problems 25 years ago, currently maintains waste well below 1%.