In case you are following closely ANVISA’s guidance on Nitrosamine, tomorrow 02/Feb/22 will be held the presentation of the final version of the guidance for the control of nitrosamines.
We will be hosting a discussion with some of our community members to share their perspective.
In case you missed it, we have several posts in the community with the guidance draft and recording of ANVISA’s presentation at the last USP-Sindusfarma Nitrosamine Workshop.
I want to share the newly published guidance from ANVISA on the Control of Nitrosamines in APIs and Medicines. Any interest from our community members to organize a Q&A session with some of the Brazil members to introduce the guide details?
I personally find interesting these on the guidance:
3 phase approach (Risk Assessment, Confirmatory testing and Process changes)
Specific expectations regarding risk assessment (334-344)
Section dedicated to Applicability of ‘Purge’ concept in line with I…
We have created this discussion board for our LATAM Nitrosamine Workshop participants
Feel free to introduce yourself to other participants, share your current work on Nitrosamines and challenges
Connect with our workshop speakers directly and opportunity to share your questions
Explore resources and discussions happening on All-things-Nitrosamines
Hi, please share the English version.
Thanks in advance
While there is no official English version of the guidance issued by ANVISA, we have a post in the community with an unofficial translation of it. You can easily find it by running a search o ‘ANVISA guidance’