Section 1.6 introduces two key Pharmaceutical Quality System (PQS) Enablers - Knowledge Management and Quality Risk Management. Section 4.1 Knowledge Management: systematic approach to acquiring + analysing + storing + disseminating information related to products + manufacturing processes + components; sources include prior knowledge from public domain + new product development + technology transfer + process validation + manufacturing experience + complaints + adverse events + product quality reviews + literature; knowledge management enables science-based + risk-based decisions throughout product lifecycle; encompasses tacit (Subject Matter Expert SME experience) and explicit (documents + databases + systems) knowledge. Section 4.2 Quality Risk Management (QRM) per ICH Q9: integrated approach across the product lifecycle; risk identification + risk analysis + risk evaluation + risk control + risk communication + risk review; risk-based decision-making for: product development + manufacturing + technology transfer + commercial scale-up + change management + investigation + CAPA + audit + supplier qualification + facility design + utilities. Q9(R1) released 2023 enhanced QRM with: subjectivity in risk assessment + risk-based formality + clarity on hazard identification + improved guidance on tools (FMEA + HACCP + HAZOP + Bow-Tie). PQS Enablers underpin all Section 2 (Management Responsibility) + Section 3 (Continual Improvement) + 4 Lifecycle Stages activities. Coordinates with ICH Q9 (R1) + Q8 (Design Space + Control Strategy) + Q12 (Established Conditions) + GAMP 5 + FDA Process Validation Guidance + EMA + PMDA + ASTM E2500 (Specification + Design + Verification of Pharmaceutical Manufacturing Systems and Equipment). ICH Q10 Section 1 + Enablers + Knowledge Mgmt + QRM applies.
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