This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts can be put into practice, and detail the value and benefits of the approaches described. In addition, this revision includes new topics and details regarding Quality Risk Management (QRM), Contamination Control Strategies (CCS), and the impact of closed processes on facility design.

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