FDA updates the Risk Based Site Selection Model (SSM) for routine Surveillance inspections. The SSM model for prioritising manufacturing sites for inspection factors compliance history of site, compliance history of establishments in the country where the site is located, history of recalls, capable foreign regulatory authority inspection history, hazard signals-Field Alert reports, inherent product risk (dosage form, sterile products). Revised MAPP (Manual of Policies and Procedures)- Understanding of CDER’s Risk Based Site Selection model details the revisions. Read More..
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