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The Biopharmaceutical Manufacturing Facilities Baseline Guide may be used by industry for the design, construction, commissioning, and qualification of new facilities for the manufacture of biopharmaceutical Active Pharmaceutical Ingredients (APIs).

The appendices consider non-U.S. regulatory differences, with input by ISPE Members from both Europe and Asia - particularly Japan.
 

Document History

  1. ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities


    ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

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