In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process parameters (CPP) that impact a product’s critical quality attributes (CQA).¹ When applying quality by design (QbD) principles it is possible to define a process design space for a unit operation and integrate real-time process analytics into pharma and biopharma manufacturing processes. This creates the opportunity for real time release testing (RTRT) to replace conventional end-product testing, potentially saving a drug sponsor facility environmental control costs, inventory carrying costs, and testing costs for product release.

• Phamatech Associates

• PAT

1. Control strategy
2. CQA
3. pat
4. QbD
5. RTR
6. Sensor