Tag: control strategy development

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…

Designing Pharmaceutical Processes for Validation Readiness

Designing Pharmaceutical Processes for Validation Readiness How to Design Pharmaceutical Processes for Stage 1 Validation Readiness Stage 1 of process validation—Process Design—lays the scientific and regulatory foundation for the entire pharmaceutical manufacturing lifecycle. It precedes process qualification and continued verification,…