Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs

Events / Workshops / Webinars
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21

@romnaiffer, in my mind, having a few Zoom/Teams meetings to discuss best practices from start to finish would be great. See my thoughts below. After this, I would hope we could move to confirmatory testing and control strategies.

Agenda:
Supplier Questionnaires
Risk Factors
Alert Structures
Format/Presentation
Final Disposition
NAP Test
Review Frequency

I’m not the one to say write vs. wrong, but I’m happy to host, if we think there is interest.

2 Likes
22

Hello, I have found that good communication skills and some adjustments in a QTA/QAA have opened doors for raw material suppliers to share more detailed information than what is found on the IPEC questionnaires, without compromising trade secrets. In addition, a teleconference with technical team to set the landscape provides them understanding for why there are so many questions.

On another note, I have found that some raw material manufacturers whose main customers are for food grade material are a bit behind, or simply state it does not apply to them.

5 Likes
23

I can share our experience with Anvisa, indeed they are requesting nitrosamines risk assessments as part of their DMF review in order to give a CADIFA.

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The best conversations has to be and must be hold in the presence of the clinicians ,because the clinicopathological correlations are the clue to the real data interpretations and not the in vitro tests! Like Ames or CPCA!
The metabolic reprogramming of the future cancer cell is the explanation that those tests /such as Ames and CPCA / has a low till zero clinical validity , because the carcinogenesis in humans could not be compared to those in bacteria and rodents , skin and human carcinogenesis are dynamic processes ! Thay are explained due the stepwise creation/ initiation of the cell clone ! This exactly could’ve triggered by nitrosamines in n drugs / and not only!
The test mentioned above could only betonate the availability / persistence of carcinogens in drugs and secure the rising cancer incidence world wide ! U have all as intelligent human beings, scientist and clinicians to think about that great manipulation/ personal
Opinion /.
We have to discuss the availability of carcinogens in drugs and agree with it? With the simultaneous intake of genotoxic , Phototoxic mutatens? And than wonder - why that cause cancer ? That’s the hallmark of cancer genesis! Triggered slowly and eloquently, with a gentle smile :blush:!
Here some data: