@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.
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.
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.