Variation requirements

Dear Nitrosamines group,
What are the requirements to be submitted to authorities to support adding a nitrite scavenger to the formula?
For oral solid dosage forms, what are the studies required?
Are there cases that may require submitting a BE study?


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My personal thoughts on this…

For the USA - talk to the FDA as soon as possible about the remediation plan, the use of a scavenger and what they require. As a minimum I would expect 3-6 months worth of stability, both real-time and accelerated, to support the application, to show that the addition of the scavenger has no impact upon the performance of the tablet from either a physical or chemical perspective, and also nitrosamine data from that stability study, to show that there isn’t an unacceptable level of increase though the shelf-life. From a BE side of things - that will come down to the FDA, the assessor and their interpretation of your formulation and the impact the scavenger could have on that - it would potentially be different for every formulation and scavenger combination.

For the rest of the world I wouldn’t expect the requirements to be any different really. You will still need to have process validation data alongside stability data to show the same - no impact upon the current performance of the product versus specifications/guidelines and that the nitrosamine is being controlled through manufacture and shelf-life.

Thanks dear, I think this workshop could help many of us .