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.
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.