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ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms
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- Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2009
- Publisher: ISPE
$253.00$505.00
This revision - the latest ISPE publication reviewed by the US FDA - 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.
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