The newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms supports the broader adoption of CM by both innovative pharmaceutical companies and manufacturing organizations. By aligning scientific principles, regulatory expectations, and industry best practices, this Guide offers a cohesive framework that supports both scientific innovations while meeting regulatory, standards, which will accelerate the delivery of safe, effective, and affordable medicines to patients through modern, efficient, and sustainable manufacturing.
“Continuous manufacturing has long been standard in other industries because it is more efficient than batch. In pharma, adoption has been slower—not due to lack of value, but because it requires a shift in mindset, planning, and day-to-day operations”, said Guide Co-Lead Anthony Tantuccio, Fellow Scientist of Continuous Tableting, Hovione LLC. “The authors of each of the chapters in this guide are subject matter experts that have implemented CM at both large and small companies. This Guide distills that experience into practical advice, so you can avoid pitfalls and realize the benefits that continuous manufacturing can offer for the patient and the organization deploying it.”
“The benefits of CM are well proven,” added Guide Co-Lead Alexandre Bonnassieux, Senior Manager, Technical Operations, Vertex Pharmaceuticals Inc. “Batch manufacturing has given our industry decades of reliable, high-quality medicines. Implementation of CM is key to further improve on our manufacturing standards—a practical guide like this can help turn scientific principles into actionable strategies for a variety of manufacturing organizations.”
“In batch manufacturing, you only find problems after production is finished—sometimes too late for patients, resulting in stockouts and supply delays. With continuous manufacturing, issues are detected in real time, only the affected material is removed, and production continues under the control of quality management system.” said Tantuccio.
The ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms presents unique and practical aspects for the development and deployment of control strategies for CM of OSD process platforms. While other modalities may draw on the same principles covered in this Guide, CM of OSD is arguably the most mature to draw practical experience and examples from. This includes topics of process model development (including residence time distribution determinations), integration of spectroscopic techniques, sampling strategy, use of statistical tools, and regulatory requirements.
This Guide also covers the established concepts relevant to CM control strategies, the practical aspects of developing these concepts in a GMP manufacturing environment (both clinical and commercial), and the relationships and considerations for lifecycle management that may be novel.
“Ultimately, it's still about getting medicines in the hands of patients faster, more reliably, within the right quality and regulatory requirements,” said Bonnassieux. “Continuous Manufacturing can help us, as an industry, to do that.”
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