Quality System and Data Integrity  
Serial Number | Inspection Items and Requirements | Regulatory/Guideline Basis | Self-Inspection Results | Issue Description and Corrective Actions  
1 | Quality Department (QCU) is independently established, with authority to approve or reject all materials, intermediates, and finished products, to review batch records, and initiate investigations, with responsibilities clearly defined in SOP. | 21 CFR 211.22(a) | |  
2 | Closed-loop operation of systems including deviations, changes, CAPA, OOS, EM exceedances; sterile-related deviation investigations cover depth of sterility/endotoxin impact assessment. | 211.192, 211.100 | |  
3 | Data integrity complies with ALCOA+ principles: no shared accounts, no data deletion/modification, audit trails enabled and reviewed, time stamps controlled. | 21 CFR Part 11; FDA Data Integrity Guide | |  
4 | Complete audit and approval procedures for suppliers (API, packaging materials, rubber stoppers, filters, culture media); complete on-site audit records for key suppliers. | 211.84; FDA 2004 Guide | |  
5 | Self-inspection/internal audit procedures cover sterility assurance system; regular implementation with corrective action tracking; management regularly reviews sterility data trends. | FDA 2004 Guide; ICH Q9/Q10 | |  
6 | Contamination control strategy (CCS) documented: integrated risk control across facility, personnel, environment, validation, monitoring, and materials, dynamically updated via deviations/changes. | EU GMP Annex 1 (2023); FDA Current Expectations | |  
7 | Complete batch production records including sterilization curves, filter integrity tests, EM data, personnel monitoring, deviations, and release conclusions, ensuring traceability. | 211.188, 211.194 | |  
8 | Annual product review (APR/PQR) includes sterility, endotoxin, EM, and simulated filling trend analysis. | 21 CFR 211.180(e) | |