Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts
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.
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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.
Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.