Farmacología clínica y biofarmacia

Abstracto

The Main Components of Pharmaceutical Process Validation

Bin Guo

Process Confirmation in Manufacturing of Biopharmaceuticals, Third Edition delves into the crucial aspects and current practices of process confirmation. It includes discussion on the final interpretation of the FDA 2011 Guidance for Assiduity on Process Validation Principles and Practices, generally appertained to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011.