ICH Safety Guidelines – Toxicology, Genotoxicity, Carcinogenicity & Risk Assessment
ICH Safety Guidelines – Toxicology, Genotoxicity, Carcinogenicity & Risk Assessment
The definitive guide to ICH safety regulations: Q3D (Elemental Impurities) and M7 (Mutagenic Impurities).
An indispensable reference for QA, QC, RA, Toxicology and GMP Compliance.
Inside you will find:
🔬 Principles of regulatory toxicology , PDE, TTC and limits for oral/parenteral/inhalation routes.
📊 Complete operational templates for Q3D and M7 Risk Assessment, integrated into Quality Risk Management flows.
📉 Complete case studies (small molecules, biotech, inhalers, generics).
🚨 EMA/FDA/PIC/S inspection expectations for Q3D and M7 — including actual inspection observations.
🔗 Integrated impurity management flowchart .
Perfect for those who need to prepare for quality audits and present robust and justified RAs.
Format: Professional PDF
Pages: 86
Updated: December 2025
Languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.