Process Validation: Monitor Batch to Batch Consistency

Quality By Design (Qbd) Is Facilitated By Real-Time Monitoring Of Crystal Population

Within the pharmaceutical industry, process performance qualification requires documentation confirming that critical quality attributes consistently meet specifications. With the adoption of the Quality by Design and Process Analytical Technology (QbD/PAT) initiatives, it has been made clear that quality cannot be tested into products and should be built in by design.

For solid dosage forms involving crystallization of the active ingredient, the crystal size distribution is always of critical importance – as it relates directly to bulk powder flow properties which in turn greatly influence content uniformity and bioavailability in the final drug product.

FBRM, as a precise and sensitive measurement of the crystal count, dimension and shape, provides an in-line confirmation of batch-to-batch consistency of the crystal size distribution. FBRM can also identify process deviations – even within the acceptable operating design space – providing real-time dynamic information that plays a key role in ongoing process improvement by aiding further understanding, optimization and control of the crystallization step.