QbD Elements in Pharma: QTPP, CQA, CMA, CPP, and Control Strategy Explained Practically Quick Summary: QbD is not theory. It has 5 clear elements. First we define QTPP – what quality we want for patient. From QTPP we derive CQA – what must be controlled. Then we find CMA (material) and CPP (process) that impact … Read more
Process Analytical Technology (PAT) Techniques: How to Move From Testing Quality to Building Quality in Real-Time Quick Summary: PAT is process analysis in real-time. Instead of taking sample to lab and waiting 2 days for result, PAT measures quality during manufacturing itself. It is a shift from product-centric testing to process-centric understanding. At-line, on-line, in-line … Read more
Knowledge of Quality by Design (QbD) in Pharma: From Concept to Design Space & Control Strategy Quick Summary: You can’t test quality into drug products. Quality should be built in by design. That’s the core of QbD. In this blog, I will explain QbD in simple language – What is QbD, why ICH Q8, Q9, … Read more
WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more
