Visible Particles, Drug Shortages, DSCSA Spotlighted In CDER’s 2020 Quality/GMP Guidance Agenda
The US FDA plans to issue new guidance this year on visible particle inspections, drug shortage risk management plans, and several guidances related to DSCSA implementation, one on identifying trading partners and the other on establishing verifications systems.
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Mylan's Manufacturing Maelstrom: Trans-Atlantic Recalls And Personal Citation By Gottlieb
GMP quality, once Mylan's calling card, is now an ongoing problem, forcing product discontinuations and apologies to customers. Firm's valsartan products have European certificate of suitability suspended as Morgantown, W.Va. facility draws US FDA warning letter.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.