On February 23, 2022 the FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for...
FROM THE INTRODUCTION: Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development,...
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