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ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms
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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.
- Edition:
- 2nd
- Published:
- 11/01/2009
- ISBN(s):
- 1931879672
- Number of Pages:
- 188
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