In a recent LinkedIn post, @andresaopedro reflected on how challenging it is to develop a comprehensive risk assessment when one has quite limited or incomplete information from an API supplier. How does your team deal with incomplete information from API suppliers? What control mechanisms are needed?
When minimum information is provided for risk assessment?
Interesting discussion thread Naiffer @Naiffer_Host.
Though its a challenge dealing with Inadeqaute information from suppliers/vendors, this requires continuous engagement with the suppliers and their Compliance/Regulatory teams. Going forward, it’s mandatory to have an inclusion of declaration status of Nitrosamine Impurities defined in the API DMF failing which the supplier maynot qualify.
The reason for not being able to provide complete information by API suppliers is also related to the fact that many of these suppliers are working on their Risk Assessments and methods and hence donot have the required information available.