Industry-wide initiatives, such as Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving today’s pharmaceutical manufacturers to improve product and process quality and efficiency. From a high level, product and process understanding in manufacturing includes identifying and monitoring Critical Process Parameters (CPPs) and Key Performance Indicators (KPIs) for one site or across the extended manufacturing network comprised of geographically dispersed sites and contract manufacturing organizations. Analysis of process data helps improve understanding for better decision-making.
As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments
Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.
Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall