Join the Conversation about Nitrosamines - Ask our Speaker a Question!

[Molly_I2]

This week we will welcome @NaifferUSP , Senior Scientifc Affairs Manager, MSc, MPH from the United States Pharmacopeia (USP). Join us in thanking him for presenting and ask questions here! Also available to converse, is our Pharma/Biopharma team of experts - Connect with @Aaron_TFS on any additional questions you may have. 

Learn more about the event here: Webinar on Nitrosamine Exchange – a USP’s Knowledge Community for All Things Nitrosamine (analytegur...

[Aaron_TFS]

looking forward to it Molly! 

[Aaron_TFS]

Excited to network following today's event! 

[NaifferUSP]

@Molly_I2 @Aaron_TFS Thanks for the opportunity to present USP's new engagement initiative in Nitrosamines. It was great to connect with the AnalyteGuru community!

[Aaron_TFS]

@NaifferUSP your welcome! I really enjoyed your presentation, I will post the questions from the webinar for you to provide answers to which we didn't get around to during the talk. 

[Aaron_TFS]

Questions from the webinar @NaifferUSP 

1. Is it possible to share information anonymously?
2. Who is member of the community?
3. Can I connect directly with the members?
4. Do I received an update of what’s happening in the community?
5. I’m not an expert, Can I ask questions?
6. What analytical methods are there for nitrosamines?
7. Will secondary amine containing APIs require batch analysis?
8. Will discussions be wider than nitrosamine such as Azido GTI impurities or is there another place for this?
9. Can we get copy of the slides?
10. How can we rely on the publicated information in the community? IS there any kind of verification behind it?
11. is there a template to conduct nitrosamine assessment?
12. "It could be possible to share an example or template for a risk assesment for all the possible sourcess/factors of Nitrosamines synthesis in order to prepárate for a Regulatory inspection?
13. Armando Tovar (México) atovar@asofarma.com.mx"
14. If a supplier A refers to presence of nitrosamines and supplier B refers to the absence. ..eventhough most of the process is same....how to overcome these issues...as a finished dosage form manufacturers

[NaifferUSP · Accepted solution]

All great questions @Aaron_TFS 

1. Nitrosamine Exchange has a feature to do post anonymously
2. Today we have to 1500+ members from all over the world, all experts and scientists linked to Nitrosamine Impurities. You can connect and network with each of them in the community.
3. Yes, by simply tagging any member or messaging them directly via the community platform.
4. Every week, we issue an update bulletin with the most recent post and activity happening within the community.
5. ANYBODY interested to learn about Nitrosamine is welcome in the community. In fact, we encourage everybody to post questions, that's how we can stir great discussions. 
6. There are SO many out there, USP, FDA, EMA, HealthCanada, EP, Thermo they all have published methods. That being said, they are just the first step into the development of a method tailored to your sample and process details.
7. Only if that secondary amine represents a risk of forming Nitrosamine Impurities. The risk assessment of your product will provide that answer.
8. At this point not. The community is focused on all-things-Nitrosamines
9. Unfortunately not
10. The information posted and shared in the community is not official or has been validated. 
11. There are many tools that have been created to serve as a starting point for conducting a risk assessment. Several of those are discussed in the community. Every organization must develop its own plan and strategy for conducting its risk assessment. 
14. Close collaboration with suppliers is fundamental for a successful and robust risk assessment. A simple claim (free or not) of Nitrosamine impurities is really far from the amount of information needed to conduct a risk assessment.