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.

FDA regulation is certainly nothing new to pharmaceutical manufacturers. Regulations such as the Current Good Manufacturing Practices guidelines have been around for years. But the FDA recently began to take a new approach to enforcing those regulations, according to experts. The agency no longer expects pharmaceutical companies only to comply with regulations such as CGMP; it also wants to see the rationale behind companies' compliance processes.

"In the old world, you recorded the end state in the submission process, which said, 'I ran this process three times. Here are the results and everything looks OK,' " says Hussain Mooraj, research director for life sciences at AMR Research. "But what was missing was, why are you doing what you are doing?"

Drug safety is the driver behind the regulations, according to the FDA. To avoid shipping bad product, many pharmaceutical manufacturers have stepped up testing. "Today, every product made is put under quarantine and they test the hell out of it," says Bob Honor, vice president of Rockwell Automation's life sciences group, referring to pharmaceutical companies' compliance efforts. Ultimately, however, even when they follow FDA orders, these companies are not avoiding risk altogether. "They are just managing risk more selectively," Honor says.

Selective risk management often means following new quality guidelines under the FDA's Process Analytical Technology (PAT) methodology, which states that quality should be built into the manufacturing process "by design." There are also risk management and quality guidelines associated with drug development that are outlined specifically for the pharmaceutical industry. These guidelines, called Q9 Quality Risk Management and Q8 Pharmaceutical Development, fall under the International Conference on Harmonization (ICH), a tripartite group comprising government regulators in the United States, the European Union, and Japan.

While such working guidelines can help pharmaceutical manufacturers get a handle on regulations, following them is not the complete answer to compliance, experts say. Instead, compliance efforts should be undertaken in a holistic fashion, not isolated to a single product line or function. In fact, approaching compliance in a tactical, stovepipe fashion could lead to inflexible processes, the experts say.

Instead, pharmaceutical companies should work on compliance and risk management collaboratively with government agencies, such as the FDA. More important, the companies need to incorporate risk management into the corporate fabric, just like the IT infrastructure. It must be defined in detail with a top-level strategy, an organizational structure, a model of categories, tools to measure and monitor risk, and ongoing optimization.

"Leading organizations, like Novartis, Merk & Co., and Shering-Plough, look at compliance as part of the operational excellence initiative," says AMR Research's Mooraj. "When you do compliance, it should not be done for the sake of nonconformance, but to better your processes."