The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...

A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...