@Naiffer_Host Thanks for including me in these group and warm welcoming.
As per my experience with different Pharma industry main challenges for analytical side is expertise and regulatory framework specific for LOD and LOQ, confusion for what are the Nitrosamines need to analyse? Need to evaluate excipient, intermediate, solvents etc require or not, for Biopharmaceutical and fermentation base product require assessment or not.
Thease are few points where industry people have not clarity. Need to focus on such points and require education for that specifically regulatory side.
Dr. Jaideep @Jaideep, welcome to Nitrosamine Exchange. Limits is a fascinating topic for the community discussion, specifically for the divergence on approaches from regulatory agencies when establishing permissible limits for specific Nitrosamines. Additionally, the bio-chemistry of Nitrosamines is quite complex, which allow the question: Are all Nitrosamine equally genotoxic?
Can you share some of those questions with our community so we can start additional discussions? I hope you find insightful our discussions here… Thx
I found it difficult to figure out how to use your site. I would be glad to help if I could but as a contract packager the responsibility for this risk assessment would be with the owner/manufacturer of the products we package. I couldn’t figure out how to post my question about the Pfizer recall…
@dinamaines Thanks. We have created a very short video explaining
How to search the community
How to reply to a discussion
How to post questions to the community
While risk assessment is the responsibility of the owner/manufacturer I’m sure you have been part of those risk assessment exercises, I believe that general insight and best practices are gold nuggets for the community.
Hello @Naiffer_Host it is my pleasure to be a part of such a wonderful group I can ever think of. Surely I will be posting questions on regular basis. Regarding the question are all Nitrosamies (NAs) genotoxic: I would like to let you know that no…basics lie in the chemistry of the molecule…NH group…same also arises if we have a diazo group (N2Cl) too. Nitrogen forms covalent bonds with DNA or cellular mechanism structures and donates its electrons. That donation creates free radicals and it is troublesome. Since in toxicology, we know dose decides the toxicity. However, we have been able to only identify and quantify 75 NAs. Maybe many are there that are out of LOD or LOQ. But limitations with in-silico software are they treat all same. Now it is something under discussion from FDA and other individual regulators too that we need to change the concept of One size fits all. Since historical data with quantified NA have genotoxic data, all cant be. Moreover, no specific study has not been identified for all 7 or 8 NAs whose values have been established. So, I am still skeptical that all NAs cant be genotoxic. In turn, genotoxic will lead to carcinogenic too. So, technically need to be argued and established upon this hypothesis.
Thank you for the invitation @Naiffer_Host. My name is Danita Broyles, and I am the Associate Director of Quality Assurance at Harmony Biosciences focusing in Analytical and Stability areas. Thank you so much for creating an information exchange on this very important topic. I am looking forward to sharing ideas and collaborating with the group concerning Nitrosamines.
@DanitaBroyles, welcome to the Nitrosamine Exchange community. I hope you find the community insightful and reach on valuable information to help you navigate the challenges of Nitrosamines.
I hope you can also share this resource and community with other colleagues. Thx
Hello everyone! This is Ping Wang, a scientific director from Janssen R&D. Main area of interests include single use systems, packaging materials, drug delivery systems, regulatory interactions, safety assessment, biopharmaceutical manufacturing process and CMC strategies; mAbs, CGT, vaccines, etc. Glad to be here!
@pwang9 Welcome to Nitrosamine Exchange - knowledge community. Great to see you and other colleagues from the packaging arena here.
We have a category in the community dedicated to #rootcauses:packaging I hope you share with us some of the challenges if any your team is facing when comes to packaging/risk assessment and control strategies. What has been your experience?
Hello @Naiffer_Host, thank you for accepting me. Hello everyone I am Gede Sputra, I am from Indonesia working for Kalbe Farma as Analytical Development Senior Manager. My team and me working to get an alternative analytical procedure for routine QC use, switching from LC-MS/MS to common HPLC.
@GedeSputra thanks for joining the Nitrosamine Exchange community. Would you mind sharing with us the current state of Nitrosamine regulation and industry implementation in Indonesia? Thx
Our community continues growing. We have reached an important milestone for us in the community’s membership this week… our 300th member!!
Welcome, @JenN (Perrigo) @GedeSputra (PT Kalbe) @Nitin (Fresenius Kabi) @lahugunjal (Macleods) @raghuwanshivinod (Strides) @Thaliasd (DIGEMID) @Drhotha (Johnson Matthey) @lucas10mauriz (Teuto) @Gtumambac (Pall) @Sandy (Lupin) @aniaurban (Cardno) @Paul_Curry (Abbvie) to #NitrosamineExchange. I was hoping you can introduce yourselves to the community, and share some of your work and activities related to Nitrosamine Impurities.
Please feel free to add your perspective to any ongoing discussions or simply start a new one with your specifi topic of interest.
Myself Lahu Gunjal, working as Analytical manager in macleods pharmaceutical Ltd.
Thanks to adding me in group for such hot topic and wonderful discussion.
Thanks
Lahu
Yes, sure. We have the same issue regarding Nitrosamines impurities. Unfortunately, high tech instrument like HRMS not widely available. Base on risk assessment, NDMA/NDEA testing has to be done on Sartan drug substance since the impurities come from synthesis proses. QC test can be carried out using HPLC, since very low Quantitation Limit not required.
The challenges come from Metformin and Ranitidine. Due to high dose of Metformin require lower Quantitation Limit than sartan drug substance.
NDMA testing for Ranitidine also required for Drug Product since degradation can occurred during manufacturing process. As we know heat can promote Ranitidine degradation to form NDMA.
Greeting. I am Kevin Cross, Ph.D. at Leadscope, an Instem Company where I am the P.I. on U.S. FDA Research Collaborations and VP of Product Engineering. I have been leading the Nitrosamine SAR workgroup along with David Ponting at Lhasa where for the last 18 months we have been working on nitrosamine reactivity. Several papers and presentations have been given. The latest was a symposium I organized on nitrosamines last week at the Toxicology Forum summer meeting. This was a 3-hour symposium. I have uploaded the description here. Slides of my talk are available.nitrosamine_toxforum_session_summer_2021_FINAL.pdf (143.2 KB)
Greetings, I am Pascal St-Laurent and I have been working as a consultant for the last 6 months after 26 years in the pharmaceutical industry. My journey includes; Quality Control, pharmaceutical research and development, method development and validation, technology and method transfers, product development (scale up, engineering and validation), investigation writing both laboratory and manufacturing, metrology, technology transfers of injectables where I became somewhat familiar with the requirements for nitrosamines. My journey took me back to my home country Canada and I am based in Montreal, QC. Looking forward to being part of this group.
Thank you for adding me @Naiffer_Host. I am Pragnesh Panchamvedi, a regulatory toxicology consultant currently based in India. My core working area is toxiclogical risk assessment. I am excited to be a part of this lively Nitrosamines scientific exchange forum.
Hi dear Colleagues, This is Sayeh Majzoob, PhD in Pharmaceutical Sciences. I work in Novartis Iran as previously QA manager for CMOs and now as Special Projects manager. We are having initiatives to ensure our CMOs make a proper risk assessment on nitrosamines and would not use sources with potential contaminations.
Greetings,
I am Tim Curran an organic chemist at Vertex. I came upon this nitrosamine hobby through the IQ consortium where I lead a working group. Glad to be part of this forum and look forward to the interactions.