Process Parameters & Critical Controls
Identifying CPPs & CQAs: A Guide to Process Robustness in Pharma
Identifying CPPs & CQAs: A Guide to Process Robustness in Pharma A Complete Guide to Identifying CPPs and CQAs in Pharma for Robust Process Control Establishing a robust pharmaceutical manufacturing process requires clear identification of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). These elements form the backbone of a well-controlled and validated process. Whether developing a new product or optimizing an existing line, QA, QC, and Validation teams must understand how to define, assess, and control CPPs and CQAs to meet FDA, EMA, and ICH expectations. This article offers a practical, risk-based, and step-by-step approach to identifying and…