1. The Quality Control Unit (QCU) is independently established, has the authority to approve or reject all raw materials, intermediates, and finished products, can review batch records and initiate investigations, with responsibilities clearly defined in the SOP. 21 CFR 211.22(a)
2. Systematic closed-loop operation for deviations, changes, CAPA, OOS, EM exceedances, and sterility-related deviation investigations cover product sterility/pyrogen impact assessments. 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 Guidance
4. Complete audit and approval procedures for suppliers (API, packaging materials, stoppers, filters, media), with full documentation of key supplier on-site audits. 211.84; FDA 2004 Guidance
5. Self-inspection/internal audit programs cover sterility assurance systems, conducted regularly with corrective action tracking; management reviews sterility data trends periodically. FDA 2004 Guidance; ICH Q9/Q10
6. Contamination Control Strategy (CCS) documented: integrates risk control across facilities, personnel, environment, validation, monitoring, and materials, dynamically updated via deviations/changes. EU GMP Annex 1 (2023); FDA Current Expectations
7. Complete batch production records include sterilization curves, filter integrity tests, EM data, personnel monitoring, deviation logs, and release conclusions, ensuring traceability. 211.188, 211.194
8. Annual product review (APR/PQR) includes sterility, endotoxin, EM, and simulated packaging trend analysis. 21 CFR 211.180(e)
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