We have tested 10 batches of our drug product for NDMA content and found to be Not detected for 9 batches. 1 batch is having a value of BLQ (LOQ is 30% of limit). This product is meant to be filed for Canada market.
Can any one suggest the right approach considering Health Canada guidance since we are in opinion to exclude NDMA from Drug Product specification.
Why have you tested NDMA in your drug product? Is there a potential risk?
If there is a potential risk of formation of NDMA, you should include it in the release as well as stability specifications of the drug product. However, you may consider a skip test if the results are below 30% of the AI limit. The risk of nitrosamines formation in the drug product is more during the shelf-life than the formulation process itself.
Step one is to determine root cause…if the NDMA is coming from the API and is not produced during product manufacture then in principle control at the API level is all you really need to do. But root cause must be established before you can make any decision.