ISPE has published the Oral Solid Dosage (OSD) Forms Baseline Guide, Second Edition - the latest ISPE publication reviewed by the US FDA.
This second edition updates content from the original Oral Solid Dosage Forms Baseline Guide to current industry standards, practices and regulatory requirements.
Specifically it addresses the latest interpretation of 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 OSD Baseline Guide, Second Edition utilises 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.
Highlights from the table of contents include concepts and regulatory philosophy, product protection, product and processing, process support and utilities, HVAC, electrical, control and instrumentation, risk-based approaches to commissioning and qualification, cost factors in OSD manufacturing, summary of quality risk-management processes, risk management tools, and HSE international regulations and standards cross references.
The first public introduction of the guide will be at the ISPE 2009 Annual Meeting Session, 'Why the New OSD Guide is Vital', to be held 11 November in San Diego, California.
