I’m Amanda Guiraldelli, scientific affairs manager at USP, and I’m located in São Paulo Brazil. I’ve been working on nitrosamines analysis in pharmaceuticals using chromatography coupled with mass spectrometry and I’m always seeking to learn more about the different sources of nitrosamines and topics related to nitrosamines risk assessment. Happy to be part of this community where I’m quite sure I’ll find rich discussions around nitrosamines.
Hi, My name is BM Rao, Ph.D. currently working at Dr. Reddy’s, Hyderabad, India (since Sep, 2015) as Head - EM QA, CQC & ASAT. I am working along with my colleagues from Analytical Science & Technology (ASAT) on the methods development for nitrosamines (both APIs & DPs) followed by method validation and confirmatory testing. Very happy to be part of this group. thank you for sharing the invite.
I am Dr. Sourish Karmakar, AGM QA. I have been managing In process QA for past 2 years. Previously, I worked in roles of both R&D and Manufacturing of Biologics (Recombinant Protein).
This is Dr Adwait Deo from Ajanta Pharma. we have been working on nitrosamine risk assessment and related method development. Nice to be part of this group and looking forward to fruitful interaction with you all.
Thanks! I lead the group responsible at Merck & Co for structural characterization and mechanism elucidation for degradation products, kinetics of formation, and the strategy for Nitrosamine risk assessment and control in drug products. Excited to be here!
A post was split to a new topic: Risk Assessment checklist, is that enough?
Hello Dr. Nitesh, how are you? Thanks for sharing your valuable insights.
For your question related to ONCO products, you can refer to EMA/369136/2020 ‘Committee for Medicinal Products for Human Use (CHMP)’ published on 25 June 2020 (Recommendations section: point no. 6), which is as follows:
“Exceptions to sections 3. and 4. include some products falling outside the scope of the ICH
M7(R1) guideline, i.e. certain active substances and finished products intended for advanced
cancer indications or when the active substance is itself genotoxic. For finished products
intended only for advanced cancer, N-nitrosamine impurities should be controlled according to ICH Q3 A(R2) and ICH Q3B(R2), as specified in the Q&A document to ICH S9. When the active substance itself is genotoxic at therapeutic concentrations, N-nitrosamine impurities could be controlled at limits for non-mutagenic impurities according to ICH M7(R1)”.
nitrosamines-emea-h-a53-1490-assessment-report_en.pdf (1.3 MB)
You can also refer to ‘EMA/409815/2020 Rev.1’ Qand A published on 29 January 2021.
2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf (499.7 KB)
How do you consider this approach?
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
4 posts were merged into an existing topic: Why LTL approach is not been considered?
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!
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?
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?
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 !!!
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.