Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption
Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’
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CMC And GMP Updates In Brief: Continuous Manufacturing, Accelerated CMC Reviews
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.
Real-Time Manufacturing Volume Reporting Could Help Prevent Drug Shortages, Woodcock Tells Congress
If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.
Survey Finds Growing Interest In Continuous Manufacturing Of New Drugs
A recent survey shows that pharmaceutical manufacturers are increasingly interested in adopting continuous manufacturing. Most respondents say they plan to use this mode of manufacturing for their new drugs.