ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms PDF

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.

Edition :	2nd
ISBN(s) :	1931879672
Number of Pages :	188
Published :	11/01/2009