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Home » FDA Clarifies Procedure for Reporting Deviations in Biologics Manufacturing
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FDA Clarifies Procedure for Reporting Deviations in Biologics Manufacturing
November 15, 2006
In an effort to help biologic product manufacturers report deviations from current good manufacturing practices (cGMPs), the FDA issued a guidance detailing the correct steps to take when an event occurs that may affect the safety, purity or potency of products.
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