Thanks @DanitaBroyles for the idea… When we thought it was a thing of the past, the more we discussed risk assessment, the more gaps we identified.
Allow me to express my concern. It has become increasingly common to encounter companies’ risk assessments founded solely upon terse, single-page documents provided by their suppliers, bearing the familiar refrain of being “free of ANY Nitrosamines.” While such assertions would be assuring if substantiated by robust investigation and accompanying data, regrettably, this is often not true.
Another prevalent approach involves the deployment of the ‘screen of Nitrosamines,’ wherein samples undergo scrutiny against a panel encompassing 6, 7, or 12 Nitrosamines. While this method provides insight into the absence of the screened impurities, it does not confer unequivocal assurance regarding the absence of Nitrosamines without comprehensive assessment.
Accessing essential information from suppliers presents, in many cases, an uphill challenge, exacerbated by the tools such as questionnaires or checklists that claim enough to meet regulatory mandates. Despite their utility in facilitating information gathering, these tools lack regulatory validation as the official means to conduct comprehensive risk assessments.
In a more critical situation (paraphrasing), “Our products contain secondary or tertiary amines. There is a possible introduction of Nitrites from the raw material.” However, “We do not intend to develop a method to test the product for nitrosamines, nitrates, or nitrites.” It leaves one with the lingering sentiment of being wished ‘Good Luck!’ in navigating potential risks.
Nevertheless, many organizations are doing a fantastic job conducting risk assessments. Suppliers sharing critical information about potential solvents, starting materials, intermediates, or specific impurities that can be critical nitrosamine precursors should not be considered sharing confidential information. In my presentations, I have shown successful examples of how some suppliers share all this crucial information without disclosing the ‘secret recipe’.
Innovative methodologies such as ‘purge’ calculations, spearheaded by @AndyTeasdale, are gaining traction in enhancing the efficacy of nitrosamine assessments conducted by suppliers.
Can you share best practices on your team or suppliers that make Risk Assessment a breeze for you?