Category: <span>Unit Operations</span>

The FDA’s ICH Q9 quality risk management (QRM) guidance material is the foundation for understanding and evaluating patient risks associated with developing and manufacturing pharmaceuticals. This three-part paper describes approaches a team of subject matter experts (SMEs) can use for implementing two important applications of QRM. Part I provides a method for identifying and remediating threat risks that may affect the product’s quality or other important aspects of a manufacturing enterprise’s lifecycle, from product research and development to commercial manufacturing. The second QRM application covered in Part II manages patient risks by identifying, evaluating, and managing risks associated with process parameters (PP) on the product’s critical quality attributes (CQAs). The final paper, Part III, describes an approach for accepting or further mitigating the risks evaluated by the QRM exercise…

Biologics Production Guidance Mammalian Cell Culture Quality Risk Management (QRM) Regulatory Unit Operations

Biologics Production Buffer Formulations Chromatography Low-Pressure Liquid Chromatography (LPLC) Manufacturing Process Automation Unit Operations