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I. GMP Audit Regulatory Requirements  1.1 Interpretation of China’s *Regulations on Drug Inspection (Trial)*  ● **Inspection Types**:  - Licensing inspections (corresponding to *Dru...…
TIME: 2026/9/15 11:12:51

FDA Audit Checklist

Quality System and Data Integrity   Serial Number | Inspection Items and Requirements | Regulatory/Guideline Basis | Self-Inspection Results | Issue Description and Corrective Actions&n...…
TIME: 2026/9/15 9:02:20

Purpose of FDA factory inspection

 Quality Management System Development and Operations: Oversee the establishment and optimization of the group headquarters' biopharmaceutical全产业链 quality management system, covering R&...…
TIME: 2026/9/15 8:52:30
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