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Full Description

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.
 

Document History

  1. ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms


    ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

    • Most Recent
  2. ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

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    ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

    • Historical Version
  3. ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms


    ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

    • Historical Version