Pharmaceutical manufacturing can achieve the same successes with APC that other industries have realized. The concepts, techniques and technology are transferable; but the industry needs to look at quality from a modern perspective.
Incentives and opportunities
Of course there is good news; actually great news. One of the main reasons (perceived or real) for pharma’s risk avoidance in manufacturing has been the regulatory environment. Yet now one of the key global regulatory agencies, the U.S. FDA, is dramatically changing its approach to quality in a positive way for everyone involved, especially the patients.
Critically, the FDA is encouraging companies to take a risk based approach to development, manufacturing and control. This is not so that it can reduce the amount of effort going into development, manufacturing and control, but redirect the efforts currently deployed to inefficient documentation efforts towards the most important aspects of manufacturing and control based upon risk management.
The incentives from the FDA come in the form of rapid approvals, more flexibility to adjust the process through continuous improvement initiatives, and reduced compliance oversight based upon modern risk management. The cost for these is simple; risk management, process knowledge, and control. These come from putting the technology in place, securing the right skills and experience (either internally or through partnerships) and focusing manufacturing and control from an integrated risk management approach.
Think big but act small
Evolution is by definition a gradual process, but can only happen when more individual facilities develop the infrastructure and change their cultures to focus on continuous improvement. When starting your journey to APC, think big but act small. Ask yourself how development, manufacturing and control will look ten years from now. How close to that vision are you now? What will it take to bridge the gaps between where you are today and where you want to go? If the gap is large, one may be overwhelmed, and react by procrastinating. Acting on a small scale, one can take quantifiable steps that will not only yield a positive return on investment, but won’t require huge capital outlays or structural changes.
In short, process control evolution is inevitable. But it must begin with you, within your facilities, divisions and companies.
About the Authors:
David A. Radspinner, Ph.D. joined Thermo Electron Corp. in May of 2005 as PAT Development Director and is located in Madison, Wis. He works on delivering PAT-related solutions for the pharmaceutical industry in areas of enhanced measurement systems, data management, process monitoring and control, process risk management, process mapping, and real-time release. He also helps customers define and implement their PAT strategy. Radspinner joined Thermo Electron from Sanofi-Aventis Pharmaceuticals, where he was the Drug Product PAT leader of their strategic PAT initiative. He developed a scientific, risk-based approach to PAT at Sanofi-Aventis on a full-scale production process for a high volume drug product leading to the first major comparability protocol filed and approved with the FDA.
Matt Tormollen joined Pavilion in January of 2003 and has more than 20 years of software industry experience. He is responsible for Pavilion’s worldwide market development, product management, communications and branding. Tormollen has been instrumental in supporting the company’s PAT solution offering, including multivariable data analysis, Soft Sensors, and advanced process control.
Figure 1: APC in Relation to the Manufacturing Automation Hierarchy
Figure 2: Fonterra Moisture Variability (before APC)
Figure 3: Fonterra Moisture Variability Reduction (with APC)