ISPE Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
With the 3rd edition of the Biopharmaceutical Manufacturing Facilities Baseline a new standard is set. It provides the latest insights on the use of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) when designing a biopharmaceutical facility to protect the product and ultimately the patient. Keeping closed processing at the core to cut the risk of (cross-)contamination at the production floor, it reviews the definition of Closed Systems by introducing the Process Zone concept providing clarity and simplicity necessary in the implementation and success of such technology. Moreover, the chapters on GMP facility layout and architecture, mechanical and electrical design and sustainability are revised and brought to current practice. The presentation will provide a structure overview of the motivation and the updates in the guideline.

Sander Thijssen

Assoc. Director BioProcess Engineering, MSD

Appearances