@ketanagravat Welcome to Nitrosamine Exchange - knowledge community. A common experience in all our consultant community members is the diversity of challenges and points of view when working with different organizations. With that unique perspective, can you share with us your hardest challenge to overcome when working with organizations that face Nitrosamines Impurities? → Nitrosamines Exchange - Learn, share and discuss best practices to implement Nitrosamine Risk Assessments
Dr. Nitish, Thanks for joining Nitrosamine Exchange - knowledge community. Speaking from my own experience doing work on education and research provides a unique lens to the topic of Nitrosamine. I know the community will welcome your experience and that particular point of view.
I invite you to visit our Analytical category and share some of your insights related to analytical challenges; we also encourage members to share information that can be useful to other community members → Nitrosamines Exchange - Learn, share and discuss best practices to implement Nitrosamine Risk Assessments
@mugeguleli Thanks for joining Nitrosamine Exchange - Knowledge community. I’m really looking forward to you sharing your experience on Excipients and primary packaging… The debate about the role of excipients and packaging materials as direct or indirect contributors is still ongoing. I hope you can visit the category of risk assessment → Nitrosamines Exchange - Learn, share and discuss best practices to implement Nitrosamine Risk Assessments and help us navigate some of the topic and questions posted there.
Hi all!
My name is Tsukasa Kikuno, Japanese.
I am a president and CEO of Pharmaceutical Impurities Safety Assessment Research Institute, Co., Ltd., Japan (PhiAS). PhiAS was established by him in February 2019 as Japan’s only neutral and fair contract research organization that is specialized in support of corporate ICH M7, Q3C and Q3D compliance. Support for ICH M7 compliance has been provided to various clients, including pharmaceutical companies (e.g. drug substances, drug products, and generic drugs), venture companies, universities and others and this support has been highly rated. I was a researcher in cytogenetics laboratory, Faculty of Sciences, Kwansei Gakuin University (1985-1987). I joined Chemicals Evaluation and Research Institute, Japan (CERI), and worked for 32 years (1987-2019). I participated in JICA-Malaysia risk management project of hazardous chemical substances as a long-term expert of mutagenicity and transferred mutagenicity tests to SIRIM Berhad in Malaysia (1998-2002). I researched in Division of Genetics and Mutagenesis, NIHS, Japan, as research student (1991), where Dr. Masamitsu Honma taught me molecular biological techniques. In CERI, I engaged in mutagenicity tests and general toxicity tests of pharmaceuticals, pesticides and general chemicals as study director. In Tokyo office of CERI, I undertook many investigations and researches for EU regulation of chemicals, GHS classification, safety data sheet, mutagenicity and toxicity assessments of chemicals and pharmaceuticals (2007-2019). I have produced reports for ICH M7, especially mutagenicity and carcinogenicity, and PDE values for chemicals. Very happy to be joined in this group. Looking forward to hearing your information.
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Hi Everyone,
My Name is Georg Pour and I am a development Scientist in mid-size Pharma Company EVER Valinject GmbH located in Austria. I am an organic chemist by training with strong focus on analytical methods (HPLC,GC, NMR,…) For the last 3 years I have been working in the field of analytical method development and supporting our Regulatory team regarding topics, Extractables/Leachables, elemental impurities and nitrosamine and generating/establishing risk assessment - processes in those areas.
Best regards
Georg
@kikuno Welcome to Nitrosamine Exchange - Knowledge community / A large track of experience on ICH M7, it’s wonderful to have you here in the community.
I would really like to hear your perspective on the current industry landscape related to Nitrosamines Impurities…We created a post to start that conversation: Current Nitrosamine Landscape in Japan? Thanks
@Georg_Ever2018 Welcome to Nitrosamine Exchange - Knowledge community / I hope you find the community insightful. Here in the community, we continue to see a debate about Nitrosamines in E&L assessment. We also host an analytical category where you can post questions or help us with some of the analytical challenges discussion related to Nitrosamines > Nitrosamines Exchange - Learn, share and discuss best practices to implement Nitrosamine Risk Assessments
I’m David Shell. I’m currently a Team Leader for Nitrosamines. My team is chartered with nitrosamine risk assessment, confirmatory testing and mitigation at Hikma, Columbus.
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Hello everyone,
I’m Jun Nagai in charge of anarytical deveropment at Maruho, Japan. I have just begun to consider risk assessment and analysis methods.
Thank you.
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Hi All,
I am Sarada Prasad Jena, working in office of risk & compliance at Strides Pharma, Bangalore. A generic pharmaceutical company catering to various markets.
Related to Nitrosamine my current role as a team member for holistic risk assessment.
Currently I am working on NDSRI Assessment.
I am looking for more discussions & way forward to this new challenge.
Very happy to join this dedicated knowledge sharing group of elite scientists across the globe.
Appreciation to our Host Naiffer for managing this group & continued dedication.
Thankyou.
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@Dshell welcome to Nitrosamine Exchange / I’m sure as leader of the Nitrosamine team in Hikma, you have come across several Nitrosamine challenges. I hope we can count on your contributions and share your experiences on tools and best practices that have been effective in your team, also the community provides a forum to discuss new challenges and ideas with other Nitrosamine colleagues. Thanks for joining
@JunNagai Thanks for joining NItrosamine Exchange / I hope you have useful information in all our categories related to Nitrosamine. I recently added you to a discussion we are hosting related to the landscape of Nitrosamine in Japan industry. I hope you can share your experience as a newcomer to the Nitrosamine Challenges.
@Sarada.jena Welcome to Nitrosamine Exchange / Wonderful to count on your experience and perspective from the office of risk & compliance. I hope you share your experience and challenges with our community in the different categories. Thx
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Hi My self Dr Manish Tillashi.I am leading the analytical method development team in Cadila pharmaceutical india.
I am more focus on nitroso impurities method development validation and control strategy.
I am thankful to admin for creating such type of knowledge forum.
Hi, I am Dr.Gopal. I am associated with MSN Pharmaceutical – Global Pharmaceutical company in India and USA, wherein I am heading Analytical R&D at US site. Being API & DP manufacturing company, we ensure our products should be free from Nitrosamines. We are extensively working on Nitrosamines risk assessment and analytical method development. I am happy to be part of the community wherein can learn and share our knowledge/ experience. Thanks
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@mtillashi Welcome to Nitrosamine Exchnage. We have a dedicated category to confirmatory testing and analytical challenges. I am hoping you can help us guide some discussion around analytical challenges and best practices here: Nitrosamines Exchange - Learn, share and discuss best practices to implement Nitrosamine Risk Assessments
@gopalv Welcome to the Nitrosamine Exchange community. Been gone through the experience of performing risk assessments for the portfolio of products. I hope you can help us provide perspective on the tools (or even lack of) that made it possible to navigate the development of risk assessment. We continue hearing from firms just looking to test 6/7 nitrosamine as part of their strategy (Testing VS Risk Assessment)
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Hi, I am Jonathan Soares. I am associated with Brainfarma Chemical and Pharmaceutical Industry in Brazil, as Regulatory Affairs analyst. Now we are extensively working on Nitrosamines risk assessments. We have found problems during carring out the assessments for finished products, once there are different approaches for this subject. So now I’m really happy to be part of this group to exchange ideas and help each other. Thank you!
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Hi I am Mijo Stanic,
Owner, CMO and Technical Director of/at Chromicent GmbH in Berlin/Germany.
Chromicent is an analytical service provider in all 3 stages of analytical life cycle management (dev/val/routine and release) and we are GMP-Certified. We also have our own analytical R&D part for the analitical solutions for the future. Since 2018 one of these main topics are the nitrosamines by using SFC-MS/MS and LC-MS/MS. Currently our 3rd publication about nitros is available (I think Naiffer already shared the link). Thank you
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Hi everyone,
Thank you for inviting me.
My name is Marcos Lima.
I work at Pfizer in Brazil in a global area (GTE) as analytical development coordinator.
I was a member at Anvisa in the Working Group on Nitrosamines in 2021 contributing to make the legislation and guideline about this subject.
Best regards,
Marcos
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