Section 2 establishes management responsibility for the Pharmaceutical Quality System (PQS). Section 2.1 Management Commitment and Leadership: senior management has ultimate responsibility for establishing + maintaining + continual improvement of PQS; demonstrate commitment through visible engagement + resource allocation + decision-making + accountability + setting tone at the top + culture of quality + product safety; ensure PQS effectiveness; designate Quality Unit / Quality Function (independent from operations + production); periodic review at appropriate intervals. Section 2.2 Quality Policy: documented + communicated + understood across organisation + linked to corporate strategy + reviewed periodically + commits to compliance + continual improvement + customer/patient focus. Section 2.3 Quality Planning: identifying + planning + communicating + measuring objectives + targets + KPIs; cascading from corporate to functional to site to process level; align with regulatory requirements + business strategy + ICH Q8/Q9/Q11/Q12. Section 2.4 Resource Management: ensure adequate human + facility + utilities + equipment + materials + IT systems + qualifications + training + experience; competence assessment + development planning + succession. Section 2.5 Internal Communication: between management levels + functions + sites; communicate PQS objectives + status + issues + lessons learned + good practices; Quality Unit + Operations interface. Section 2.6 Management Review of PQS: periodic review of: PQS effectiveness + objective achievement + audit results + customer/regulatory feedback + supplier performance + CAPA status + improvement initiatives; output: improvement actions + resource allocation + PQS evolution; documented + actioned + monitored. Coordinates with FDA Quality Metrics + EMA + PMDA + ISO 9001 Section 5 (Leadership) + Section 6 (Planning) + Section 9 (Performance Evaluation). ICH Q10 Section 2 + Management Responsibility applies.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.