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by Stephanie Neil, MA Editorial Staff   | Abstract: | Pharmaceutical companies, under increasing FDA scrutiny, must become agile, yet predictable, to ensure product quality. New, holistic risk management strategies can help keep them out of trouble. |
There's a list that no pharmaceutical, life sciences, or food manufacturer wants to be on. It's called the FDA Enforcement Report. Published weekly by the Food and Drug Administration and the Department of Health and Human Services, the list details product recall actions taken against manufacturers. But even if your company is lucky enough to have skirted the public recall list, you can't afford to let down your guard. If an FDA inspector has visited one of your sites recently, you could receive a warning letter, giving you 15 to 30 days to respond before legal action is taken, which could lead to anything from a slap on the wrist, to discontinuation of a product line, to a big, fat fine. Clearly, no FDA-regulated company has it easy these days. But pharmaceutical manufacturers may have it the toughest. These companies face very specific FDA guidelines governing drug development and product quality, and the FDA has become more demanding when it comes to enforcing the rules. As a result, pharmaceutical companies are being forced to reevaluate their operational and manufacturing processes and to implement new systems that emphasize agility and support activities such as product quality, lot traceability, and, of course, regulatory compliance. [Click to continue] |