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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