The sterile injectable manufacturing site of a multi-national pharmaceutical company experienced a sudden and unexpected increase in units with visible crystals. Despite the drug being on the FDA drug shortage list, manufacturing was temporarily halted. Sufficient determination of the root cause of the crystallization with proposed countermeasures was required to restart manufacturing. The company brought skilled MetaExpert in to lead the charge.
Sterile injectable crystallization is a niche technology that requires extensive expertise. MetaExpert assembled a cross-functional Black Belt team which included operators, technicians, process engineers, and chemists. In close collaboration with his team of functional subject matter experts (SMEs), MetaExpert developed and deployed a strategy to return the product to production and removal from the FDA drug shortage list. This was accomplished by:
Under MetaExpert’s leadership, the team of subject matter experts employed DMAIC (Define, Measure, Analyze, Improve, Control) and statistical tools to successfully identify the root causes and develop countermeasures to address each cause. In addition, MetaExpert led the team in creating a detailed implementation plan, updating the GMP (Good Manufacturing Processes) documentation. Finally, the team validated that the formulation was super-saturated and inherently prone to crystallization over time. A long-term plan was created to reformulate the product.
MetaExpert and his team of SMEs worked tirelessly to implement countermeasures to the root causes identified. As a result:
The project focused on reducing variation in tablet hardness, a characteristic critical to dissolution time and the release of medicine. By identifying and mitigating the sources of variation in the tablet press dyes, variation in tablet hardness was reduced by 30% and all tablet harness deviations were eliminated.
Thanks to MetaExpert unrelenting efforts and DMAIC expertise, a medically necessary drug was safely returned to the market. In addition, MetaExpert enabled the pharmaceutical company to mitigate future risks and increased costs of crystallization.
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