Specialty & Emerging

Nitrosamine Impurities: Risk Assessment and Control

The ICH M7(R2) addendum risk classification framework, common root causes of nitrosamine formation, and lifecycle risk assessment.

What this course covers

This course covers the regulatory background behind the nitrosamine contamination crisis and the risk assessment requirements FDA and EMA now expect as a result, the ICH M7(R2) addendum framework for nitrosamine risk classification, common root causes of nitrosamine formation including API synthesis routes and nitrite-containing excipients, and control strategies and confirmatory testing approaches once a risk is identified.

Who this course is for

Regulatory affairs and CMC staff managing nitrosamine risk assessments
QA and analytical staff involved in confirmatory testing

What you'll learn

The regulatory background behind the nitrosamine crisis and FDA/EMA's resulting risk assessment requirements
The ICH M7(R2) addendum framework for nitrosamine risk classification
Common root causes of nitrosamine formation, including API synthesis routes and nitrite-containing excipients
Control strategies and confirmatory testing approaches once a risk is identified
How to build and maintain a nitrosamine risk assessment across a product's lifecycle

Why it matters

Nitrosamine contamination drove one of the largest and most sustained recall waves in recent pharmaceutical history, and the risk assessment obligation it created did not end with the original recalls. New formation pathways continue to surface, and a one-time assessment is no longer considered sufficient by regulators.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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