Quality Risk Management Audit Readiness (ICH Q9)
Assess your quality risk management programme across every FDA system
Overview
What's Inside
Quality Risk Management is the overarching discipline that connects every quality subsystem in pharmaceutical manufacturing. ICH Q9 and Q10 require that risk-based thinking be embedded in decision-making across production, facilities, laboratory controls, materials, packaging, and documentation — yet many organisations struggle to implement QRM beyond isolated risk assessments.
This 13-page checklist provides a structured self-assessment covering ten domains: Quality System risk governance, Production System risk controls, Facilities & Equipment risk protocols, Materials System supplier and incoming material risks, Laboratory Controls OOS/OOT risk procedures, Packaging & Labeling risk management, Documentation & Change Control, Training & Personnel competency, Complaint & Recall Management, and Monitoring & Continuous Improvement.
Each section contains ten Yes/No/NA audit questions drawn from real inspection focus areas. Use it as a site-wide QRM health check, a pre-inspection self-assessment, or a framework for building out your Contamination Control Strategy and quality risk management plan.
Why It Matters
FDA and EU inspectors increasingly expect documented, risk-based rationale behind every quality decision — from cleaning validation hold times to supplier qualification frequency. Sites that cannot demonstrate a systematic QRM programme face scrutiny across all six systems. This checklist ensures your risk management is comprehensive, not siloed.
What's Covered
Sections in this checklist
- Quality System risk governance, roles, and NQE procedures
- Production System risk controls and aseptic filling risk plans
- Facilities & Equipment validation, cleaning, and maintenance risks
- Materials System supplier risk assessment and grade change protocols
- Laboratory Controls OOS/OOT risk procedures and data integrity
- Packaging & Labeling visual inspection and recall risk management
- Documentation & Change Control risk assessment integration
- Training & Personnel QRM competency and refresher programmes
- Complaint & Recall Management risk-based escalation and trending
- Monitoring & Continuous Improvement benchmarking and review
Who It's For
Target roles
Regulatory Basis
ICH Q9, ICH Q10, 21 CFR 211, EU GMP Part I Chapter 1, FDA Compliance Program 7356.002
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