Impurities Workshop Part II: Nitrosamine Impurities - Live Online Training
Practical Approaches for Assessing the Risks of Impurities
Wednesday, 28 October 2026 9 .00 - 15.45 h
Course No. 22759
Speakers
Dr Ulrich Rose
Straßburg
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Osama Chahrour
Astra Zeneca
We offer a discount up to 800€, when booking the training together with the courses “Impurities Workshop Part I: General Strategies for Identification and Control of Impurities” and “Impurities Workshop Part III: Elemental Impurities”. Book these three courses as a combination here.
Target Group
This Live Online Training is addressed to all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This training will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.
Objectives
In Part II of the Impurities Workshop the relevant aspects of root cause analysis and risk assessment with respect to potential Nitrosamine contamination in drug substances and drug products will be discussed. You will hear what you need to know about the required risk assessments for medicinal products containing chemically synthesized APIs. In particular you will learn
which root causes for Nitrosamine Impurities should be considered,
which practical approaches can be applied to assess the risks related to potential Nitrosamine contamination,
which regulatory actions are to be taken in case of Nitrosamine Impurities and what authorities expect in these cases.
You will get advice from industry experts on how to cope with the challenge of performing risk assessments. Furthermore, you will be informed about the European Pharmacopoeia activities (policy) on mutagenic impurities with focus on Nitrosamines.
Background
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 a genotoxic and carcinogenic agent in animals and is classified as a Class 2A carcinogen to humans. After a referral under Article 31 of Directive 2001/83/EC triggered by the European Commission 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. In an EMA Questions & Answers Document various potential sources of Nitrosamine contaminations are described. In September 2019 EMA published a press release where pharmaceutical companies were advised on steps to be taken to avoid nitrosamines in human medicines. In another document which appeared at about the same time Marketing Authorisation Holders are requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs. As a consequence in case of contamination with Nitrosamines Marketing Authorisation Holders are requested to file a variation application.
Programme
Part II: Nitrosamine Impurities Practical Approaches for assessing the Risk of Nitrosamines and other Mutagenic Impurities in Drug Substances and Drug Products
European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines
Ph. Eur. General policy on DNA reactive impurities
Control of Nitrosamines in Ph. Eur.
Changes in individual and general monographs following the Sartan case
New general chapter on control of nitrosamines
Root Causes for Nitrosamine Impurities and other Mutagenic Impurities – Practical Approaches to Assess the Risks
Development of a systematic risk based approach
Key factors and the development of a decision tree
API
Drug Product
Packaging
Case Study: Conducting a Nitrosamine Risk Assessment - Evaluation through Case Studies
Several case studies will be presented and a risk assessment for different scenarios is shown taking into account e.g. manufacturing equipment, dosage form of the drug product, etc.
Nitrosamines and other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements
The assessor’s approach: principles of toxicological assessment
Structural alerts
Limits and Permitted Daily Exposure
The ALARP principle
Examples of low daily dose drug substances
Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
Nitrosamines – the Valsartan case
Potential mutagenicc residual solvents
Impurities derived from metal catalysts
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 990 APIC Members € 1,090 Non-ECA Members € 1,190 EU GMP Inspectorates € 595 The conference fee is payable in advance after receipt of invoice
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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