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by Lauren Gibbons Paul, Contributing Editor Posted on Monday, November 19, 2007 10:48:20 AM   | Abstract: | Pharmaceutical companies are struggling to reduce process variability, and the FDA's Process Analytical Technology (PAT) initiative aims to help. |
In some respects, the life sciences sector is unique among industries. Every move pharmaceutical and biotech manufacturers make is tightly monitored by the U.S. Food and Drug Administration (FDA), and the quality of the end product is literally a matter of life and death. So, it's no surprise that these manufacturers do everything possible to ensure the highest quality of their end product at all times. But quality comes at an extremely high cost. Goods are laboriously tested before being released to the market, resulting in an industry average for rework and scrap rates of 50%, according to AMR Research (Boston). The costs of this post-facto approach to quality control are high -- a single scrapped batch can cost a company as much as $3 million to $4 million, according to AMR. These error rates, which are much higher than those in other process industries such as oil & gas and food & beverage, mean the entire industry suffers not only in terms of cost but in protracted cycle times. Pharma cycle times typically run 30 to 90 days, according to AMR, but when processes go awry, that time can double. [Click to continue] |