Would like to understand about Risk Assessment strategies being employed for Nitrosamines evaluation in Primary Packaging Materials.
Are there any Formal methods , acceptance criteria as yet established wrt Nitrosamine control in Pharmaceutical Excipients & Primary Packaging Materials.
Request members to share their views/experience.
Thanks @DAB. Have you had chance to watch we posted on this topic lead by @AndyTeasdale and @areumer They both discussed great case studies. In the presentation Andrew mentioned Volatilization of Nitrosamines trapped in the blister pocket during sealing, work done by Novartis. Not sure if this is published thought. Maybe @Founding_Expert’s colleague from Novartis that we could invite to the community to share additional information?
1 Like