In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus reducing the wastes of waiting and excess inventory already identified by lean manufacturing.

The early efforts with PAT were focused chiefly on the single aspect of developing and applying analytical tools for timely in-process measurements. However, to fully realize PAT’s goal of complete understanding and control of the manufacturing process, a bigger toolkit must be used. The tools recommended by the FDA are multivariate tools to handle design, information gathering and analysis, process analysis, process control, and continuous improvement. With these tools, pharmaceutical manufacturers can move toward the common goals of reduced cycle times, fewer rejects, increased automation, and continuous improvement in the process that are shared by PAT and lean manufacturing.

The pharmaceutical industry has historically taken a reactive approach to process and quality control – that is, issues were addressed as they arose and not before. Today, however, the industry is moving away from that stance, and toward a quality-by-design approach – an approach that meshes well with the waste reduction, and continual improvement objectives of lean manufacturing. However, the pharmaceutical industry has been slow to take to both the PAT initiative, as well as lean manufacturing solutions, basically for the same reasons. The main obstacle, and probably the hardest to overcome, has to do with cultural issues and mindset. A deeply entrenched attitude of risk aversion in the industry has resulted in a narrow focus on avoiding mistakes, rather than improving processes. Because of this, error-free documentation (largely paper-based) becomes more important than advanced knowledge of the process – a philosophy that is in direct conflict with the risk-based approach and process understanding set forth by PAT.

Another factor is that some companies simply aren’t ready for advanced control from a technological standpoint. Chart recorders – where operators manually record data on paper batch records – are still being used in some plants, and transitioning from this early evolutionary stage to the principles set forth by PAT places an enormous negative impact on a company’s ability to analyze data and control processes, take necessary corrective and preventive measures, and pursue continuous process improvement.

The pharmaceutical industry has been similarly slow in fully adopting lean manufacturing, again, because of culture and mindsets. The highly compartmentalized nature of the industry fosters a manufacturing process composed of many individual parts rather than one continuous, integrated flow. Improving a process that isn’t quite a process yet can be very challenging. Additionally, there’s a reluctance to make the necessary changes – batch size,for instance – when those changes result in the added burden of extensive documentation and testing. As with PAT, the very things that need improvement are preventing companies from taking the necessary steps toward that improvement.

While the principles of the FDA’s PAT initiative share similar goals with lean manufacturing solutions, and are well suited to work in unison, or at least in tandem, there are also similar obstacles preventing their full implementation. However, those obstacles are far less daunting when pharmaceutical consultants and lean manufacturing consultants step in to advise and guide the way.

To learn more about how lean manufacturing strategies can streamline your business and improve your bottom line, visit Smart Lean Manufacturing.