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The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.
The International Society of Pharmaceutical Engineering (ISPE) announced on May 3, 2022 that it has released a new guidance document for the continuous manufacturing of oral solid dosage forms. Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms reviews unit operations used in continuous manufacturing and establishes equipment requirements for systems in an integrated process train. The guide also considers changes in physical and automation requirements that enable each unit to work together.
Continuous manufacturing has become more integrated in the development and production of pharmaceutical products. According to ISPE, this creates a demand for more modular and flexible systems and a wide range of products and production control strategies. The guide provides a resource for designing and integrating continuous processing equipment.
“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, in a press release.
“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, in the release.