thanks a lot Eleni
Indeed, it’s a great help.
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I have a question for this topic. In EMA Q&A 10 there are 3 calculation methods for total nitrosamines (option_1, option_2-fixed, option_2-Flexible). Can we choose any of these methods or is there any order to choose a calculation method? If it is up to me, I would choose option_2-flexible. Because the calculation method is simpler and more understandable.
In EMA Guideline it is stated : Please also refer to the decision tree in Annex 1 for further guidance (pg 28/28). Also justification of the applied option is expected.
Alternatively, WHO EFPIA recommends for Post Confirmatory testing):
If more than one N-nitrosamine is included on the specification, the total risk level calculated for all identified N-nitrosamines should not exceed 1 in 100,000. This could be achieved for example by the following specifications: each individual N-nitrosamine should be below its own acceptable limit and the following equation also should be satisfied: [(Imp 1 level / Imp 1 limit) + (Imp 2 level / Imp 2 limit) + etc…] x 100% ≤ 100%
Thank you for your answer,
When I look at the decision tree you mentioned, it asks if the option 1 approach was applied. Can we directly say no to this? If we can say this, the other question in the tree is whether you will apply option_2 fixed or option_2 flexiable. Here, I understand that I can continue by choosing option_2 flexibale. Am I right about this?