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.
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FDA’s Peter Marks says educating academics about CMC would help them understand why it is necessary to do things in a standardized way. He predicts the field will move away from individual manufacturing platforms in the next five to 10 years.
The US FDA will begin work on operationalizing a Quality Management Maturity rating system following a public vote of confidence from its outside advisory committee. There are plenty of key details still to be worked out.
The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.