I was told by a CMO that they are no longer going to create and/or revise existing nitrosamine risk assessments for their customers. They will just keep a copy of a nitrosamine risk assessment that the NDA holder creates on file. Is anyone else experiencing this? Typically we are used to received the assessments from our CMO’s since they are intimately involved with the manufacture and synthesis, and our company reviews and approves it after final edits are made. I’d love to know how other companies handle this.
@DanitaBroyles Thanks for the topic… I am alarm by the CMO decision to NO longer revise the existing nitrosamines risk assessment. This is a living document that needs to be evaluated every time anything changes in the process, definitely not a ‘do and forget’. The same apply for any other risk assessment on residual solvents, E&L, impurities, etc…
Wondering if others in the community are receiving the same pushback from their manufacturing partners or suppliers
It is more helpful if our CMO partners help write the assessments as they have the most up to date knowledge concerning all that has to be included in these assessments. They are our “boots on the ground” and know the processes more intimately and in more in detail. They have the best view points into all that is entailed and needed for a thorough assessment. I am pleased to see that some companies still work in partnership to keep these assessments up to date.
I would suggest to review the Technical Quality Agreement and define the responsabilities further. Normally, the CMO should take the risk assessment as a “living” document provide updates when needed. The other way around is that the MAH performs the risk assessment (orchestate the process) but including the CMO to provide input.
In both cases, the CMO should be always supporting the process.
As per regulatory expectations, the MA holder has a primary or at least equal responsibility in ensuring the adequacy and completeness of the nitrosamine risk assessment. Sole reliance on the CMO’s evaluation is not considered sufficient. In case any gaps or uncertainties are identified, they should be proactively discussed between the MA holder and the CMO and addressed collaboratively to ensure compliance and patient safety.
I agree that the MAH is equally responsible for the accuracy of the assessment and compliance with guidance documents and regulatory expectations as the CMO. However, the CMO will have more intimate and up to date knowledge sometimes as they are the ones physically manufacturing the drug product and testing the product.