When it comes to process and quality control, the pharmaceutical industry has historically taken a reactive approach. When something broke, then it was fixed-that is, when a product-quality issue arose, only then was it addressed. Now, however, that’s changing, and the industry is moving away from post-product quality testing and toward a quality-by-design approach. And this approach meshes well with the twin objectives of lean manufacturing-waste reduction and continuous improvement.
In 2003 the FDA promulgated its 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 efficiencies, both manufacturing and regulatory, and has 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 inventory identified by lean manufacturing.
Early on, efforts with PAT were focused chiefly on the single aspect of developing and applying analytical tools for timely in-process measurements. But 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), tools for process analysis, tools for process control, and tools for continuous improvement. Then, with these tools, pharmaceutical manufacturers can move toward goals shared by both PAT and lean manufacturing: reduced cycle times, fewer rejects, increased automation, and continuous improvement in the process.
Still, the pharmaceutical Industry 4.0 Technologies Pdf has been slow to take to the PAT initiative and to lean manufacturing solutions and for largely the same reasons. The main reason, and probably the hardest to overcome, is one having to do with cultural issues and mindset. In this industry a decades-long attitude of risk aversion has produced a narrow focus on avoiding mistakes rather than improving processes. So error-free documentation (and that largely paper-based) becomes more important than radical knowledge of the process. The problem here is that PAT calls for a risk-based approach and process understanding.
In addition, some companies and some divisions within plants just aren’t technologically ready for advanced control. Some still use chart recorders where operators manually record data on paper batch records. Starting from this early evolutionary stage with respect to technology has 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 mainly because of, again, culture and mindsets. The industry is highly compartmentalized, and so the manufacturing process is composed of many discrete parts rather than being a continuous, integrated flow. It’s difficult to improve a process that isn’t quite a process yet. Also, there’s a reluctance to make necessary changes when changing a batch size means the extra burden of extensive documentation and testing. As with PAT, the very things that need improvement prevent companies from taking the necessary steps toward that improvement.
It seems that the principles of the FDA’s PAT initiative and lean manufacturing solutions are well suited to work in unison or at least in tandem. They have similar goals Manufacturing Engineering Journal and similar obstacles to their full implementation-obstacles that can seem far less daunting when pharmaceutical consultants and lean manufacturing consultants step in.

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