Hello Dr. Archana,
Welcome to Nitrosamine Exchange community. Glad to connect with you through this forum. Appreciate your insights and the risk assessment resources shared by you are of great help to the community members.
Do you follow or prefer any specific tool to conduct risk assessment in APIs and DPs?
Hello Dr. Adwait,
Glad to connect with you and welcome to tthe community of experts.
@leonardo.allain Welcome to the community. Thanks for sharing your experience related to Nitrosamine. I recalled the wonderful presentation you deliver as part of USP Brazil workshop serie.
Can I ask you to share with our community some of the tools or resources (beside M7) that in your experience are a go-to when defining or developing Nitrosamine Strategy?
@AmandaGuiraldelli @Mrunal Welcome to ‘Nitrosamine Exchange’, We have some great community members whose work is focused on analytical work. One of the key pillar on Nitrosamine overall strategy. looking forward some great discussions
@drbmrao welcome to the community. I am sure the community will welcome all your experience on dealing with Nitrosamine Impurties. Please feel free to browse some of our discussions and share some of your experiences. Thx
Hello everyone,
My name is Ward D’Autry. I’m a project manager E&L and structural elucidation at Nelson Labs, located in Leuven, Belgium. In this position I’m working closely with chromatography - mass spectrometry experts, also on the topic of nitrosamines. From an E&L perspective, not surprisingly, we notice an increased interest in nitrosamine testing from packaging suppliers as well as pharmaceutical end-users. Although some aspects around nitrosamine formation from packaging are known (rubbers, nitrocellulose blisters…), there are still some blind spots in our current understanding. I’m happy to be here to exchange insights on this topic!
Cheers, Ward
2 Likes
Welcome @Adwait to our community. Your experiences and contributions on N-Nitrosamines risk assessment will be welcomed and appreciated by all our community members… Best practices, lessons learned is something one does not find published or by listening to a webinar.
I know we can count with your contributions here… Thx.
@Sourish welcome to our Nitrosamine Exchange community. We recently opened a category within the community dedicated to biologics. It’s unclear to some of us how N-Nitrosamine play a role in Biologics products. Maybe there is an opportunity to share some learnings crossing over from small molecules? Can you plase share some of your perspective related to Nitrosamine in Recombinant Protein?
2 Likes
Olá e bem-vindo à Comunidade Nitrosamines Exchange.
Se você é novo no assunto ou já está conosco há algum tempo, estamos realmente felizes em tê-lo aqui e nos ajudando a construir conhecimento e melhores práticas para realizar avaliações de risco eficazes para nitrosaminas.
Para começar, por favor, apresente-se. Estamos ansiosos para saber quem você é, que tipo de trabalho você executa e há quanto tempo você o faz.
Sinta-se à vontade para convidar amigos e colegas que se beneficiarão em fazer parte da nossa comunidade Nitrosamine Exchange.
Embora o idioma oficial do fórum seja o inglês, também queremos agradecer e dar as boas-vindas aos membros que falam português.
The challenges for nitrosamines for E&L are not very different if any than impurities in drug products. The limits are about the same (ALARP) and the formulation can be as challenging. The regulators do want to push limits lower. However, does this makes sense scientifically. If you can detect ng/component of a nitrosamine as an extractable but that component is used that delivers a dose to the patient over 30 days. The exposure to the patient is in fg or billions of molecules. How does this compare to environmental exposure of the same chemicals?
1 Like
Hello, I am Himali Ujagare, leading API Regional Regulatory activities for Europe, Canada, WHO and ANz regions at CIPLA Ltd. India.
We are extensively working on Nitrosamine impurities and over past 2 years I have been closely associated with our cross functional teams involved in these activities. This whole process has been challenging and we are working towards overcoming these challenges based on our experience so far and also based on evolving guidance from various Regulators.
I am glad to be part of this knowledge sharing community and will be happy to share my thoughts and experiences with the Industry peers and also will be looking forward to learn more about this topic… Thank you !!!
1 Like
Warm Welcome to our community @CarstenWorsoe @zdravkovic12 @HelmutR @schwemg @padmakar @nathananderson @AlbertoEAlvarez @Ana_Castro @JavierFernandez @rameshg @frigyes.
Our goal here is to create spaces for scientists to come together around emerging issues related to Nitrosamine. It represents a true change in how USP engage and empower our stakeholders outside the official and formal compendial processes.
All discussions in Nitrosamines Exchange community will be led and shaped by you and all our members.
I was hoping you can introduce yourselves to the community, and share some of your specific experience related to Nitrosamine.
Thanks
Hello Everyone, I am Padmakar Wagh, working with Waters India as demo lab and excellence center Manager. We have been actively working with Nitrosamines for quite some time now and as a part of support to our customers and scientific community, developed methods for various drug products and substances. I hope to learn a lot more through this forum and wish to contribute in best of my capacity to collectively address this cohort of concern.
Regards,
Padmakar
3 Likes
Hi All - I am Dan Lettiere, Sr. Principal Scientist in Pfizer Drug Safety Research & Development as a nonclinical toxicologist. Among my roles is supporting both research and manufacturing with regards to extractables, leachables and contaminants. Additionally, I am a company representative to the ELSIE (Extractables and Leachables Safety Information Exchange) consortium. I am excited to join this group to learn and actively participate in the development of standards with impact to the pharmaceutical industry.
1 Like
Hi,
My name is Babuji Katta working as a Manager at USP India Reference Standards Laboratory. I am new to this Nitrosamine topic whereas, working on analytical techniques of LC-MS, GC-MS for various Quantification analyses and Elemental Impurities using ICP-MS as per USP <232> and <233>.
I am excited to be a part of this group which will enhance my knowledge and expertise by exchanging the ideas and valuable insights from eminent speakers and stakeholders.
Thank you.
1 Like
@padmakar welcome to Nitrosamine Exchange. Although our community is focus on Risk Assessment, all your contributions and analytical perspective will be welcome by the community members.
1 Like
@lettieredj Welcome to Nitrosamine Exchange, I’m sure your supporting role within Pfizer comes with great learnings in researching E&L. I’m sure the community will appreciate any shared knowledge. We have several colleagues in the community working on same area.
Please help us by replying to existing discussions or post new questions you would like to share with the community. Thx
Hi, I am Yahya Nuruddeen, associated with Avalon pharmaceutical industry– A Leading Pharmaceutical company in MENA , wherein I am heading the Analytical R&D. We are a finished product manufacturing organization. We, like others, are involved extensively on Nitrosamines risk assessment and analytical method development with different approaches and understanding across pharma industry the stand on Nitrosamines. I have been closely working with regional FDA and following the evolution of the guidelines from USP & EMA for Nitrosamine topic to outline the global needs and expectations from regulatory bodies. I am glad USP is providing this platform and be part of the knowledgeable community and experts around. As mentioned by our host Naiffer knowledge sharing and exchange of ideas will be the greatest asset to help us practically have insights and develop acceptable clarity on the subject.
1 Like
Hi All,
My name is Aaron Lamb, Pharma Biopharma Marketing Manager at Thermo Fisher Scientific. My background is in in Pharmaceutical analytical testing and development. I held the position of R&D and Pharma Team Leader at Intertek Pharmaceutical Services Manchester working there for 5 years leading a team of QC & method development scientists. More recently I have worked at Thermo for 5 years in Application Specialist roles mainly performing method development on pharmaceutical, environmental and food vertical markets. I also have a masters degree in Chemistry from The University of Manchester. Since moving into a marketing role this year I have been leading pharmaceutical analytical development collaborations involving innovation, automation, and making analyses simpler and more amenable to Pharma QA QC laboratories. The analysis of nitrosamines is a key focus area for me and the pursuit of a multi drug product workflow is my main goal. Its nice to be here and meet everyone.
Aaron
1 Like