Although pharmaceutical manufacturing has a rich history of delivering lifesaving drugs and therapies to patients, quality control concerns within manufacturing facilities as well as patient safety incidents prompted the creation of regulatory agencies. Thus, the history of pharmaceutical manufacturing is intertwined with the evolution of worldwide regulations intended to ensure the safety of medicines, writes Paul C. Collins in the May AIChE Journal Perspective article, “Chemical Engineering and the Culmination of Quality by Design in Pharmaceuticals.”
“Many of the regulatory expectations were enacted during a time when the ability to provide process monitoring and true process control in pharmaceutical manufacturing facilities was not technically possible,” says Collins. “Therefore, the quality controls exacted upon pharmaceutical manufacturing processes, referred to as Good Manufacturing Practices (GMPs), were largely procedural in nature.” The focus on procedural compliance meant that pharmaceutical manufacturing technologies lagged behind those of other chemical processing industries.
The current regulations were formed to help existing manufacturing...
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