FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act). The SSM will use risk factors consistent with section […]

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