Search

The article aims to address the challenges and present a framework for the implementation of material traceability applicable to continuous pharmaceutical manufacturing. The traditional manufacturing practices have complied with the guidelines for decades. The traditional batch processes continuous processes have a flow of material traveling through them, from one unit operation to the next.

The article offers information on the implementation of material traceability to continuous pharmaceutical manufacturing. Topics discussed include acceptable tablet critical quality attributes in a single batch; residence time distribution of the continuous system and predicting behaviour of powder during a component batch change; and systematic framework for implementation of material traceability.