In the production of pharmaceutical tablets, a QbD approach can bring benefits that include faster process and product development, reduced waste, and the capacity to deal with the variability in raw materials, Tim Freeman – owner of UK-based powder flow and characterisation analysis company Freeman Technology – told in-Pharmatechnologist.com.
Freeman was talking at last week’s TechnoPharm/POWTECH show in Nuremberg, Germany where he told us that while QbD had been more traditionally applied to batch production, there is a shift towards continuous manufacturing within the industry and a QbD approach will become essential for tablet makers to adopt.
“For the development of a continuous process, QbD is almost a fundamental requirement as there is no opportunity for retrospective testing within a series of continuous process steps like there is following each operation of a batch process,” he explained.
“It is therefore critical to understand the design and control space of the process, a key objective of QbD.”
However, Freeman added drugmakers need to have a good understanding of the relevant material properties and process variables in order to take a QbD approach, both of which determine the quality of the intermediate and final product, and called for continuous – for want of a better word – research in the field.
“Whilst QbD has encouraged better material and process understand, there remain many relationships between material properties, process variables and product quality that are yet to be understood. Identifying the material properties that are relevant, rather than just easily attainable remains an on-going objective.”
And on and on and on and on…
According to Freeman: “Continuous manufacturing will inevitably become more widely adopted, replacing many of the traditional batch processes,” and has many advantages over batch production – most notably the ability to efficiently scope material properties and Critical Process Parameters (CPP) and to ascertain how changes impact the properties of the material leaving a particular stage of the continuous line.
“This means that product and process development can be achieved in a matter of hours rather than days and weeks. As a consequence, time to market of a new product can be reduced and equipment can be utilised more effectively,” he said, adding such production can also lead to more consistent product and higher yields.
While batch manufacturing continues to be commonplace, there has been a call over the past few years by a number of processing companies towards the continuous process. Onyx Scientific recently invested $140,000 in continuous equipment at its facility in Sunderland, UK following demand from its clients, while last year across the pond the US Food and Drug Administration (FDA) teamed up with GEA Process Engineering to implement a validate continuous processes.
At the time, GEA spokesman Michael Fazio told this publication that while the project is a work in process, it signals the “start of the end for batch manufacturing.”