Quality by Test was the only way to guarantee quality of drug products before FDA launched
current Good Manufacturing Practice. To clearly understand the manufacture processes …

Continuous drug product manufacturing is slowly being implemented in the pharmaceutical
industry. Although the benefits related to the quality and cost of continuous manufacturing …

The implementation of process analytical technology and continuous manufacturing at an
FDA approved commercial manufacturing site is described. In this direct compaction process …

A dynamic model of a continuous direct compression process for pharmaceutical tablets is
presented. The objective is to assess the impact of the variability from the feeder system on …

The implementation of continuous pharmaceutical manufacturing requires advanced control
strategies rather than traditional end product testing or an operation within a small range of …

There has been a noticeable shift from pharmaceutical batch processing towards a more
continuous mode of manufacture for solid oral dosage forms. Continuous solid oral dose …

Near infrared (NIR) spectroscopy has been widely recognized as a powerful PAT tool for
monitoring blend uniformity in continuous manufacturing (CM) processes. However, the …

Direct compaction (DC) is the preferred choice for tablet manufacturing; however, only less
than 20% of active pharmaceutical ingredients could be compacted via DC as its high …

Near-infrared spectroscopy (NIRS) is nowadays an established analytical technique in the
pharmaceutical industry. The aim of this review is to present the progress of NIRS in …

As is the case with batch-based tableting processes, continuous tablet manufacturing can be
conducted by direct compression or with a granulation step such as dry or wet granulation …