Hi, I’m Yosuke Mino. I take responsiblity for ICH M7 and also work as a member of working group for risk assessment of nitrosamine impurities in drug substances and products in my company, Japan Tobacco. I got the Neiffer’s excellent materials of Joint MHLW/PMDA-USP Workshop last week and rushed into this community. Now I’m very happy to have scientific and exciting discussions in this group. Let’s overcome this strong and difficult enemy, nitrosamine impurities together!!
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Hi all, I am Bettine Boltres, working for WEST Pharmaceutical Services as Principal Scientific Affairs and Nitrosamines was one of my busiest topics last year 
So, I am happy to learn more for other involved people and exchange as this topic evolves.
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@GENERAPHARM Thanks for joining the Nitrosamine Exchange. With those years’ immersed on the Nitrosamine challenges, I am sure you can share some perspectives or tools that have become useful to you and your team when conducting a risk assessment. Any perspective to share?
@Julien Thanks for joining the community; welcome!
18 months working on establishing a roadmap? What has been the biggest challenge faced in that process? I’m sure we can start a discussion thread on that…
@BettineBoltres Welcome to our community!
Last year? I am sure you have overcome some enormous challenges with your team. Do you mind sharing some of those with the members?
@Yosukemino thanks for taking the invitation. Great audience and participation at MHLW/PMDA-USP Workshop. Welcome to the community!
Hi everyone, I am Tony Bristow, Principal Scientist for Measurement Science, based in Chemical Development at AstraZeneca in Macclesfield in the UK. I have been working on the nitrosamine issue for approximately 2 years, focussed on AZ’s trace analysis strategy. This has included the implementation of new technology and methodology in both analytical development and operations QC. I look forward to collaborating with you all. Cheers. Tony
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Hello everybody, I am Ulrich Rose from EDQM in Strasbourg France. I am head of division A in the European Pharmacopoeia department and my group is responsible for the elaboration of monographs on APIs, finished products, general methods and herbals. In this context we are also in charge of the elaboration and revision of texts related to the nitrosamine issue. I am looking forward to future exchanges with you.
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Dear colleagues,
My name is Vimal Sachdeva and am from the World Health Organization (WHO), Geneva, Switzerland. I have been working with the WHO since 2010 as a Technical Officer (Inspector) within the Inspection Services of the Prequalification Unit. I am mainly responsible for the GMP inspections of the APIs (drug substances/DS), drug products (DP) and vaccines facilities located around the globe. Prior to joining the WHO, I worked with Singapore’s Health Sciences Authority as a Senior GMP Auditor.
As an inspector, I am responsible to ensure DS & DP manufacturers have an adequate quality management system in place whereby suppliers of the solvents and reagents are periodically audited as per GMP requirements. An adequate system of recovered solvents is in place regardless of whether recovery of solvents is carried out on the same manufacturing site or outsourced. The recovered solvents are adequately tested before they are used back in the manufacturing process, with the traceability maintained.
I am happy to part of this Nitrosamines Community@USP and looking forward to sharing our experiences and learning from each other.
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Greetings all, sorry for my delayed introduction to the Exchange members. I am currently the Vice-Chair of the General Chapters - Chemical Analysis Expert Committee and the Chair of the Joint Steering Committee for Nitrosamines in Pharmaceuticals in USP. In my day job, in the recent past I was responsible for developing analytical methods, strategies and laboratories (HPLC-MS/MS and GC-MS/MS) for nitrosamines in pharmaceuticals. In addition, I was responsible for developing the analytical responses to global HA queries and comments. Looking forward to many productive discussions.
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Sorry that I did not identify myself in the original post - Mark Schweitzer
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Hi everybody ! My name is Céline Martin and I am a toxicologist in Eurofins (France). At the end of 2019 my team has developed a risk analysis method for pharmaceutical products based on currently available guidelines. We have already worked on different types of pharmaceutical products and even some boderline products between pharma and medical devices. We try to keep up to date with the evolution of the nitrosamines field and try to make this method evolve. Thank you for setting up this group which I am sure will be very helpful to me
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@celine.martin003 Welcome to the community. It’s quite intriguing the model you mention. I understand Eurofins have been conducting a lot of work with several companies on that front. Do you think we could host you for a brief presentation about the basics of that ‘risk method’ and some of the challenges that faced when developing the approach? I’m sure there are a lot of lessons learnt there to share with the community.
@schwemg thanks for joining the community and your leadership on USP General Chapter Joint steering committee. I hope you find this forum productive and insightful. We continue growing the community and joining efforts altogether to face Nitrosamine Challenges!
Dr Vimal @Vimal thank you for taking the invitation to join our Nitrosamine Exchange community. As you can see this community provide a forum for everybody dealing with Nitrosamine to come together and share knowledge, information, and challenges. I’m happy to have you here to share and contribute your perspective. Welcome!
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Dr. Rose @Ulirose57 welcome to our Nitrosamine Exchange community. This community provide a forum and a voice to everybody facing Nitrosamine challenges. we come together to share best practices, information, knowledge, deepen discussions and share outcomes… Welcome!
@TonyBristow welcome to our Nitrosamine Exchange… Looking forward deepen discussions on the analytical challenges that we will face moving forward as companies embark on the confirmatory testing phase. Please also let me introduce my colleague @AmandaGuiraldelli leading our analytical technical engagement. Welcome!
Hi everyone! My name is YongMoon Lee, a professor working with LC-MS/MS analysis at College of Pharmacy, Chungbuk National University in South Korea. I am leading a research project for pharmaceutical analysis, especially genotoxic impurities such as NDMA. I read the ICH M7(R2) Q&A that should provide clearer explanation about the M7 Guideline. But, I still have a few question to know more.
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Prof Lee @ymleefn welcome to Nitrosamine community. Your perspective and contribution would be a great asset to the community. Your work in analytical development can be key in some of our discussions.
Dear Nitrosamine Community,
I’m David Frigyes of Egis Pharmaceuticals, Budapest, Hungary. My work is connected to nitrosamines in several ways. I used to be the person responsible for genotoxic/mutagenic impurities in our company which included mutagenic assessments based on different kinds of QSAR, determining of the relevant limits, purge factor calculations and so, and more general tasks, like developing the mutagenic impurity workflow. In this way I consulted a lot with toxicologists, process chemists, chemical safety experts and analytical chemists. As an analytical chemist, I also develop, apply, and validate LC/MS/MS methods for determining nitrosamines in APIs and drug products.
I am very happy to be part of such an information exchange platform, as I have a lot of urging questions in the field (e.g. applying read across for nitrosamines having no literature TD50 values but having structural relatives) but much less answers, and I feel that I’m not the only one so. It is still a very new field and getting to know new questions, new solutions and new points of view are very important.
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