The key takeaway for the OSD Baseline® Guide is to give owners, engineers, and equipment vendors a tool for developing designs for their facilities.”
Bethesda, Maryland USA (PRWEB) December 09, 2016
The International Society for Pharmaceutical Engineering (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 the http://www.ISPE.org/training for an upcoming event.
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 more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.
For more information contact:
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)