Baseline Guide Volume 2, 2nd Edition: Oral Solid Dosage Forms

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Published: November 2009
Pages: 188
Table of Contents ( 543 KB)

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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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