Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
“This Guide serves as a reference for continuous manufacturing of oral solid dosage forms, providing guidance for companies, regulators, engineering firms, and vendors engaged in this technology,” said Guide Co-lead Gregory Connelly, Senior Director, Continuous Manufacturing, Vertex Pharmaceuticals.
NORTH BETHESDA, Md. (PRWEB)
May 03, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced the release of the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms. This Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment requirements for each system to function as part of an integrated process train. While most of the units are well-understood and used in batch manufacturing, the Guide considers the changes in physical and automation requirements that will allow each unit to work in concert as part of a successful continuous manufacturing platform.
“Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial production, with minimization or elimination of scale up activities, all leading to Real Time Release. It offers potential safety benefits and requires a smaller facility footprint,” said Guide Co-lead Dave DiProspero, Director of Pharmaceutical Process Technology, CRB.
As more companies integrate continuous manufacturing into their development and commercial operations, an increased demand for more flexible, modular, and robust systems accommodating a wider range of products and production control strategies is anticipated. This Guide provides a valuable resource for new and existing companies as they design and integrate continuous processing equipment into their operations, highlighting best practices and opportunities for enhancement to both vendors and end-users already engaged in developing continuous manufacturing lines of the future.
“This Guide is intended to serve as a comprehensive reference for continuous manufacturing of oral solid dosage forms, providing guidance for pharmaceutical companies, regulators, engineering firms, and vendors engaged in this emerging technology,” said Guide Co-lead Gregory Connelly, Senior Director, Continuous Manufacturing, Vertex Pharmaceuticals.
Purchase the ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms, the latest among ISPE’s many educational resources, online at ISPE.org/Publications/Guidance-Documents.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 20,000+ Members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.
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