Live Online Training: Pre-Conference Session APIC/CEFIC Conference: Nitrosamine Impurities - GMP and Regulatory requirements

Live Online Training: Pre-Conference Session APIC/CEFIC Conference: Nitrosamine Impurities - GMP and Regulatory requirements

Seminar Nr. 17692


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Marieke van Dalen, Aspen Oss B.V., The Netherlands
Dr Andrew Teasdale, Astra Zeneca, United Kingdom
Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany


During this pre-Conference Session you will hear an update on how to deal with Nitrosamine Impurities from a GMP perspective and how to handle cases of Nitrosamine contamination in terms of filing changes/variations. You will get to know
  • Which “lessons learned” future risk mitigation strategies can be based on
  • How a comprehensive supply chain quality oversight should look like
  • What has to be considered regarding the CEP procedure in case of Nitrosamine Impurities
You will receive first hand information from speakers representing  the European QP Association and APIC.
This pre-conference session ideally complements the following 23rd APIC/CEFIC Global GMP & Regulatory API Conference.


In June 2018 EU authorities were notified that a Chinese API manufacturer has detected the presence of N-nitrosodimethylamine, NDMA, in batches of Valsartan. NDMA is known to be genotoxic and carcinogenic and is classified as a Class 2A carcinogen to humans. After a referral under Article 31 of Directive 2001/83/EC the CHMP assessed the impact of the presence of this impurity on the benefit-risk balance of valsartan-containing drug products and issued a recommendation whether the concerning marketing authorisations can still be maintained or should be suspended.
Meanwhile, different Nitrosamines (NDMA, NDEA and others) were detected in almost every drug product which contains a sartan derivative as an API. Marketing Authorisation Holders have been requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs.


This pre-conference session is of interest to all personnel involved in risk assessments of drug substances and drug products regarding potential Nitrosamine contamination. Scientific staff, Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments as well as people working in the regulatory affairs area are addressed.


Nitrosamine Impurities – Lessons Learned
  • Initial cause of Valsartan contamination and other causes
  • Article 31 and its implications
  • Where do we go from here?
How to evaluate Risks associated with Nitrosamine Impurities
  • Key factors of a systematic risk based approach
  • Challenges of assessing the risks of
    - Drug Products
    - APIs and Excipients
    - Packaging Materials
    - Implication of ICH M7
Nitrosamine Impurities and Supply Chain Quality Oversight
  • How to deal with the challenge of complex supply chains
  • What the QP has to consider
  • Communication – which parties and key persons have to be involved?
Nitrosamine Impurities – handling Changes/Variations in a global Environment
  • Variations/Changes as consequences to mitigate the risks
  • Filing a variation/change
  • Is a global approach workable?


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