ICH Q9(R1) — Gap Analysis
Quality Risk Management — ICH Q9(R1) 2023 RevisionAbout ICH Q9(R1)
ICH Q9(R1) is the harmonised framework for Quality Risk Management in the pharmaceutical industry, originally adopted in 2005 and revised in January 2023. It provides principles and examples of tools applicable across the product lifecycle: development, manufacturing, distribution, inspection, regulatory submission, complaints, deviations, and product transfer/discontinuation. Q9(R1) clarified subjectivity in risk assessments, the formality of QRM, and risk-based decision-making.
Issuing Body
International Council for Harmonisation (ICH) — adopted by EMA, FDA, PMDA, MHRA, Health Canada and others
Edition
2023
Coverage
Systematic process for assessment, control, communication, review of risks to quality across the lifecycle of medicinal products and APIs.
Typical Users
Pharmaceutical manufacturers, API producers, contract manufacturers, biopharma, ATMP developers, marketing authorisation holders, inspectors, regulators.
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
ISO Xpert — Get in touch
UK-based consultancy specialising in management-system gap analysis, training and certification preparation across ISO, API, Halal, GFSI, ESG, cybersecurity and industry-specific standards.
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