Nitrosamines and Impurities Resource Kit

Learn how to comply with the given regulations Access the updated Nitrosamine and Impurities resource kit created by Arjan Timmerman & Antonia Wierzbicki, Pharma Market Development Managers EMEA at Waters.

Over four years ago, the nitrosamine crisis shook the pharmaceutical world, and it still remains a hot topic. Since then, more stringent regulations have been put in place. According to the EMA guidelines Step 2: Confirmatory testing should now be completed in the identified active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination. Submission of any changes should include confirmatory testing.

If you want more information on how to comply with the requirements of ICH M7, watch this webinar. It provides an overview of a systematic approach to the conduct of a mutagenic impurity risk assessment, providing concrete examples. It also examines the future of ICH M7.

Watch the webinar now →

Fill in the form below to access your impurity resource kit.

The resource kit includes:

• Brand new resources to help you assessing your risk
• New Webinars to learn about the regulations and how to update your methods
• Authority (FDA, EMA, USP) information
• Podcasts

Contact us with any question about impurity analysis, GTIs and nitrosamines!

Arjan Timmerman

Pharma Market Development Manager EMEA at Waters

Email: arjan_timmerman@waters.com

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Antonia Wierzbicki

Pharma Market Devlopment Manager EMEA at Waters

Email: Antonia_Wierzbicki@waters.com

Connect with me!

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