ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

A new ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment has been published that provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use and comply with regulatory requirements