Solid dosage guide released

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 


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.