Control of Nitrosamine Impurities in Biological Medicines: how to cope with regulatory guidelines? 

In this White Paper we offer an overview on EMA’s guidance for human medicines regarding the detection, management, and prevention of presence of N-nitrosamines, covering its recent update on the scope of September’s 2019 “call for review” to include biological medicinal products.

In it you will find out:

  • What is expected from Marketing Authorisation Holders (MAH) and applicants for human medicines
  • An Outline of the CHMP's assessment report and the topics it covers
  • Considerations about product prioritisation and root causes for presence of N-nitrosamines
  • Where to find the relevant information about this matter
  • A set of 4TE’s recommendations to tackle this complex issue that encompasses the entire supply chain

iRISK™ - The Risk Management Platform


We deliver iRISK™ to our clients. What is iRISK™?

iRISK™ is the next generation Risk Management Platform for the pharmaceutical industry to identify, quantify and prioritise risks, enabling the formulation of the risk mitigation strategy throughout the processes and products lifecycle.

iRISK_nitrosamine (2)-02-1

4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.


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