Pharmaceutical companies take several factors into account when deciding whether to switch from established batch processes to better performing ones, including continuous processing. Such issues include the need to cut cost of goods (CoG), improve product quality consistency, increase process robustness, prevent human error by implementing automation, and so on. However, some challenges remain for some companies integrating these new ways of processing into a current good manufacturing practice (CGMP) environment. One issue is the adaptation of a quality management system. As a drug substance producer and equipment supplier, Novasep knows how quality requirements need to be addressed in this context. We have developed a downstream process (DSP) control strategy to drive a complete, integrated process line on a single skid. Here, you will discover how.
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