FDA regulatory oversight and enforcement have never been more intense or potentially more costly. According to the business intelligence firm FDAzilla, the agency is on pace in 2011 to break its record for 483s for the third year in a row, issuing well over 10,000 citations a year—that's one every 52 minutes. For biopharmaceutical companies, with their highly complex and expensive operations, the total cost of cGMP compliance continues to constitute a significant percentage of the cost of goods sold.
Meanwhile, a variety of factors have made compliance and quality more challenging. Complex global supply chains increase the likelihood of lapses. Economic pressures to cut costs can result in compromised processes and increased operational as well as quality risk. Conversely, anxiety about regulatory action and inadequate understanding of risk can lead to expensive gold-plating and redundancy in quality and compliance activities. Company growth, the introduction of new products, and entry into new global markets can also attract an increase in regulatory scrutiny. In mergers and acquisitions, achieving consistency in quality and compliance can be especially daunting, particularly when a traditional small-molecule manufacturer acquires a biologics manufacturer or licenses a biologic product, thereby requiring interaction and compliance with a totally different branch of FDA with which it has little or no prior experience.
In the face of these pressures, the business case for optimal quality and compliance is compelling: improved operating performance, greater productivity, less compliance risk, less rework, and fewer interruptions of supply to the market resulting in lost revenue. Yet, in many companies, compliance problems persist, often because the company culture consists more of fighting fires than of thinking right-first-time and maintaining a reliable state of quality and compliance throughout the company. For an organization to do this successfully—and sustainably—this mindset and behavior focused on quality compliance must start at the top and be emulated by individuals at all levels and in all functions within the company. Moreover, in a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance and benefits of this thinking and behavior and appreciate the risks of not adopting it.Consider the wildly divergent views of quality that were uncovered when a major biopharmaceuticals manufacturer undertook a comprehensive assessment of quality across a number of its global operations. The company's manufacturing sites, as well as corporate headquarters, were polled on such questions as how well leadership defined and communicated their vision of the desired quality culture, whether management had identified what was required to create and sustain a quality culture, whether the individual had the tools and resources to get his or her job done correctly, and much more. When asked whether the right behaviors were encouraged for sustaining a quality culture, a strong majority of respondents at one site responded favorably, yet overall, barely one third of the staff polled at several other sites, including their corporate headquarters, responded positively.
Not every dimension that was assessed turned up such divergence. For example, nearly everyone agreed that they were held accountable for the quality of their work; and by overwhelming majorities throughout the company, respondents agreed that if they observed noncompliant activities they felt comfortable calling it to someone's attention. But in many areas there were wide divergences and in others—like whether the company's people had the skills to do a high quality job—there was low favorability almost across the board. It also emerged that the company was perceived by employees as focusing on short-term fixes in quality issues, and that personal development, teamwork, rewards, and recognition were inadequate for promoting a quality culture. Instead of a single, unified environment, the company had many disparate cultures.