ISPE has announced the third edition of the ISPE Baseline® Guide: Oral Solid Dosage (OSD) Forms. This newly revised guide is available in book and PDF format.
“The key takeaway for the OSD Baseline® Guide is to give owners, engineers, and equipment vendors a tool for developing designs for their facilities”, said Dave DiProspero, Director of Pharmaceutical Process Technology, CRB Consulting Engineers. “It’s not a prescriptive how to guide, but it’s more of a guidance document to allow you to build your arguments in your design cases in an oral solid dosage form tablet and capsule facility.”
The third edition of the ISPE Baseline® Guide: Oral Solid Dosage (OSD) Forms utilizes both current and new technologies, such as process analytical technology (PAT); continuous manufacturing processes, and other inventive paths to help meet regulatory requirements and pursue industry best practices. This publication emphasizes product, process, and protection, based on the increased regulatory requirements for OSD forms manufacturing. The purpose for this guide is to provide a tool for constant structure for regulatory interpretation, while allowing a flexible, innovative and compliant approach to facility design, construction, commissioning, and qualification.
This updated Baseline® Guide was created by an internationally diverse team, under the guidance of:
• Jack C. Chu, PE/MBA RPA Associates/Merck & Co., Inc. retired, USA
• Dave DiProspero, CRB Consulting Engineers, USA
• Robert E. Matje, CPIP, RemTech, LLC, USA
The work was supported by the ISPE Oral Solid Dosage Community of Practice (OSD COP). Find the new edition of the ISPE Baseline® Guide: Oral Solid Dosage (OSD) Forms on the ISPE website.
ISPE also offers training related to Oral Solid Dosage through the ISPE Training Institute. Please refer to www.ISPE.org/training for an upcoming event.