ICH Experts Aim To Set Elemental Impurity Exposure Limits For Topical Drug Products
Executive Summary
ICH expert working group is encountering challenges in setting permitted daily exposure limits for elemental impurities in topical drugs, the group's rapporteur says. Nevertheless, the group is forging ahead and plans to have a Step 2 draft document ready for public consultation in May.
You may also be interested in...
The Quality Lowdown: Cadmium, Quality Metrics, Heparin Testing And Continuous Manufacturing
ICH relaxing a new limit for inhaled cadmium in drugs; FDA relaxes timeline for quality metrics site visit invitations; US FDA looks for heparin test to sort the porcine from the bovine and ovine; and universities win FDA grants for research into continuous pharmaceutical manufacturing.
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.