Mastering the Art of Regulatory-Driven Specification Setting: A Creative Approach
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Mastering the Art of Regulatory-Driven Specification Setting: A Creative Approach
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About this listen
This audiocast highlights the importance of setting specifications for FDA-regulated products to ensure quality and safety. The FDA provides guidance on scientific-based specifications that should be regularly reviewed. Specific requirements exist for various dosage forms, and testing should follow validated methods and established specifications. Compliance with FDA regulations allows for tailored specifications while meeting federal law.
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