Continuous Manufacturing Poised to Disrupt Pharma Sector
This article was originally published in The Gold Sheet
As pharmaceutical companies begin taking advantage of continuous manufacturing, they are realizing how it can transform an industry rooted in batch processing. Now they have drafted a survival guide.
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ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.
The COVID-19 pandemic has prompted the ICH to delay by six months its efforts to develop Q13 guideline on continuous manufacturing, now not expected until May 2022.
The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.