As ICH Q3D Metal Impurity Limits Near, Industry Worries What New Tests May Find
This article was originally published in The Gold Sheet
Executive Summary
With ICH planning to propose Q3D metal impurity limits in June and USP requiring new metals test methods soon thereafter, pharmaceutical companies are wondering whether any of their ingredients might fail the tests, perhaps requiring them to reformulate products or suspend production. Early indications from FDA and industry testing are largely reassuring, while highlighting some areas for further inquiry.
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