Ensuring Real-Time Quality In Manufacturing
A few years back, US drug authority Food and Drug Administration (FDA) published a guidance work that introduced the concept of Process Analytical Technology (PAT) and redefined quality assurance and pharmaceutical manufacturing for the future. In the same guidance a concept known as "real-time release," was introduced, which is defined as "the ability to assess and certify the suitable quality of final and/or in-process product based on process data". PAT enables the introduction of innovative technologies into manufacturing in the pharmaceutical industry. In today's competitive environment, firms must strive to enhance pharmaceutical quality control while lowering production costs. PAT’s goal is to improve understanding and regulate the manufacturing process, which is as per the FDA's existing drug quality system. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities, and ...