Another significant accelerator for change will be increased interest in benchmarking activities. Historically, our industry has not worried about comparative metrics. However, with increased pressure to perform, there is significant interest in gauging progress against other best-in-class performers within the industry. Previously this sort of benchmarking has been achieved through the compilation and analysis of survey data. Today, however, there are benchmark databases available, which are constructed from actual performance data from industry organizations. This data is scrubbed to ensure anonymity but represents the true — not perceived — level of performance achieved by best-in-class organizations. What does this mean for our industry with regard to maintaining a renewed focus on scientific understanding? First, Cost of Poor Quality (COPQ) data can now be used to gauge improvement in our quality systems. Key manufacturing metrics such as Overall Equipment Effectiveness (OEE), a metric which measures the percentage of time equipment is utilized to make quality products, and Cycle Erosion, which measures our ability to manage minor stops that cannibalize cycle time, can be used to chart progress towards great productivity. When coupled with QbD activities, the two types of metrics allow management to effectively and efficiently steer product development while encouraging process stability. If combined with risk-based methods, added benefits of reduced cost, resources and time can be realized as part of the marriage of these two benchmarking methodologies.
Drug Pedigree Legislation
Perhaps the least obvious but potentially most significant driver for change to consider is FDA’s decision not to delay the drug pedigree legislation requirement. A growing number of firms are purchasing API from overseas suppliers. India, China, Croatia and Korea all are major suppliers of API to European and U.S. pharma companies. With this emergence has come a heightened concern about ensuring product integrity. While not an explicit component of the ICH and cGMP guidelines, the ability to effectively implement anti-tampering technology — such as RFID — requires an in-depth understanding of the process train, sources of variability, and risks to product integrity. The same tools to characterize the process as specified in ICH Q8 and Q9 will need to be applied to the drug pedigree process. This merger of regulatory, technical and business sensibilities will elevate the urgency in adopting these new principles.
So let’s keep in mind that the rules that determine what is acceptable from a product development perspective are changing. Effectively integrated strategic and tactical goal-setting is becoming more prevalent. Coupled with the emergence of low-cost, highly skilled CROs overseas, the strategic exposure to a misstep will continue to escalate, prompting us to establish a more methodical roadmap to ensure business and technical risks are addressed. This synergy between business, technical and regulatory drivers will, for the first time, force us to embrace the new data-driven roadmap demanded by the new regulatory guidance.