Risk Assessment & Q(SAR)

  • What software are recommended to perform an ICH M7 (Q)SAR analysis?

  • If we use a laboratory to make (Q)SAR determinations for a DMF, does the (Q)SAR laboratory need to be certified?

  • Do impurities that are predicted to be purged from the process, e.g., using Mirabilis, need (Q)SAR assessment?

@fernandaw you’re exactly the kind of person we want to have in this community. Thanks for becoming one of our first members!
You have shared some amazing resources on risk assessment, What would you say is the most challenging aspect of Risk Assessment?

There are many challenges involved with nitrosamines. I can speak from a Brazilian Pharma company perspective since this was most of my experience.
There is a need for API manufacturers to understand that the nitrosamines that should be evaluated are not only that list that was published by the authorities, but any potential nitrosamine should be risk assessed.
Calculating purges may also be challenging because this approach is not so well known by many API manufacturers. And while the Pharma industry may be able to help with the scientific rationale, they lack access to the detailed manufacturing process which is considered confidential by most API suppliers.
The advances in understanding of what is risk is also a challenge, because companies establish their protocol on how to perform the risk assessment based on the information available at the time, but additional studies are done and published constantly, which may change the understanding and potentially require that companies revise the way they do the risk assessment.

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