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Implementing Elemental Impurities Testing: ICH Q3D, USP <232> and <233> Requirements
A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs.
Now this guideline is being broadened to affect all approved Rx’s, branded and generic alike. Phase II implementation of ICH Q3D, USP <232> and <233> is about to take place. You have until Jan. 1, 2018, to get ready.
FDAnews is stepping into the breach with a timely presentation featuring a recognized expert, Dr. Wayland Rushing of EAG Labs. Dr. Rushing has led CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems.
Starting with a recap of the history of elemental-impurity testing, you’ll move on to examine:
Drug and biologics makers, API suppliers and excipient manufacturers all will benefit from this presentation. Make haste though — Jan. 1, and full compliance, will be here before you know it.
Dr. Wayland Rushing is Director of Scientific Affairs, EAG Labs. For 15+ years he has led CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems. He boasts expertise in chemistry, manufacturing and controls program design, analytical development and regulatory submissions.
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