ISPE has released Oral Solid Dosage (OSD) Forms Baseline Guide, Second Edition, at its annual meeting in San Diego this week. The FDA-reviewed publication updates content from the original work to current industry standards, practices, and regulatory requirements.
The not-for-profit association says the guide addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance related to the design, construction, and validation of solid dosage manufacturing facilities. A non-theoretical approach gives readers guidance on solving problems and addressing regulatory inspections and compliance issues.
Topics include regulatory philosophy, product protection, process support and utilities, risk-based approaches to commissioning and qualification, and cost factors in oral solid dose manufacturing.
- here's the table of contents [1]
Related Article:
GMP deviators keep paying [2]
Links:
[1] http://www.ispe.org/galleries/publications-files/ISPE_BG_vol2-OSD2_TOC.pdf
[2] http://www.fiercepharmamanufacturing.com/story/gmp-deviators-keep-paying/2009-11-04