ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms

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

Published:

11/01/2009

ISBN(s):

1931879672

Number of Pages:

188