ISPE Releases Oral Solid Dosage Forms Baseline Guide
- Posted on 01 January 2010
ISPE has announced the release of its Oral Solid Dosage (OSD) Forms Baseline Guide, Second Edition.
This second edition updates content from the original Guide to current industry standards, practices, and regulatory requirements.
Specifically, it addresses the latest interpretation of Good Manufacturing Practice (GMP) requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction, and validation of the OSD manufacturing facility.
The guide utilizes a practical, pragmatic, non-theoretical approach, giving the reader guidance on solving problems and serving as a valuable tool for addressing regulatory inspections and compliance issues.
