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Home » FDA Clarifies Procedure for Reporting Deviations in Biologics Manufacturing
FDA Clarifies Procedure for Reporting Deviations in Biologics Manufacturing
October 18, 2006
In an effort to help biological 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.