CRB Contributes to ISPE OSD Baseline Guide

CRB Contributes to ISPE OSD Baseline Guide
Posted: Dec 07 2016
The ISPE OSD Baseline Guide, Vol. 2 Third Edition has been officially released and is now available to the industry. CRB is proud to be a part of this important document and recognizes all the hard work that went into this very important publication.

According to CRB's Dave DiProspero, Director of Pharmaceutical Process Technology - who was the re-write steering committee co-leader and a contributing author - this effort took well over three years to accomplish and involved nearly 100 professionals from around the world. The guide went through an extensive international industry review and several hundred comments were issued and addressed.  Final review and additional comments came from the ISPE Guidance Documents Committee, consisting of senior, well-recognized industry leaders. It was a challenging undertaking, with lots of bumps along the way, but the new guide will set the stage for OSD Factories of Today as wells as the OSD Factories of the Future.

Congratulations to Dave, as well as other CRB contributing authors including Mark von Stwolinski, Mike Wilson and Aimee Penko.

The ISPE Baseline® Guide for New and Renovated Oral Solid Dosage (OSD) facilities focuses on compliance with the current regulatory expectations. The Guide is intended to be used by various industry professionals for the planning, design, engineering, construction, commissioning, qualification and operation of both new and renovated pharmaceutical OSD facilities. It is intended to be used to develop technically sound and compliant solutions while offering flexibility to meet specific facility and project needs.

The guide can be found on line here! 

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