The pharmaceutical industry’s current focus on manufacturing efficiency can be traced back to the early 2000s and the introduction of Quality by Design (QbD) alongside a near simultaneous increase in generic activity. The result was a compelling alignment of regulatory and commercial interests. As ‘Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach’ made clear in 2004, “quality and productivity improvement share a common element – reduction in variability through process understanding”. Competing effectively in today’s marketplace requires knowledge of how to process materials to a highly consistent product and by extension a robust understanding of which material attributes influence in-process behaviour.
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed and operated on the basis of empirical correlations between material properties and performance. The development of materials properties databases (MPDs), for pharmaceutical excipients and actives, has the potential to enhance such correlations and, more generally, to facilitate activities throughout the pharmaceutical lifecycle. A growing body of work in this area shows exciting promise, illustrating the capabilities of MPDs to add value within the QbD environment that now prevails.
Click here to read the full article ‘Material Properties Databases to Advance Pharmaceutical Processing’ in Pharmaceutical Engineering.