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  • lianhuajin replied to the topic Regulations with quality in the forum Quality Control and Quality Assurance 7 years, 6 months ago

    The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s)
    I found the types of CGMP Drug Inspections online.
    • Surveillance Inspections
    – Risk-based frequency
    – Sites selected by risk model and local judgment
    • For-Cause (Compliance) Inspections
    – Local/HQ/Center initiated, e.g., f/u past violations
    – External complaint/allegation
    • Pre-Approval and Post-Approval Inspections
    – Center established criteria (product-specific)
    – Center or local office initiated for-cause