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// September 15, 2023
Pharmaceutical Continuous Manufacturing: Regulatory landscape in the spotlight at USP...
The science of pharmaceutical continuous manufacturing (PCM) may not be entirely new but increasing interest in adoption of advanced manufacturing technologies (AMT) including PCM among industry and policymakers in recent years has been accompanied by strong support by FDA.
// September 15, 2023
Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hu...
// August 29, 2023
Part two: Industry examining FDA guidance on nitrosamines...
This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recently publishing new or revised guidances on nitrosamines.
// August 23, 2023
Part One: Industry examining FDA guidance on nitrosamines...
Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S. Food and Drug Administration (FDA). In this two-part Quality Matters blog series, we take a look at the FDA’s recent guidance on nitrosamines and what it means for industry.