I. GMP Audit Regulatory Requirements 1.1 Interpretation of China’s *Regulations on Drug Inspection (Trial)* ● **Inspection Types**: - Licensing inspections (corresponding to *Dru...…
Quality System and Data Integrity
Serial Number | Inspection Items and Requirements | Regulatory/Guideline Basis | Self-Inspection Results | Issue Description and Corrective Actions&n...…
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&...…