Stability study requirement (RNA based feed additive product) for zone 4 countries

[Sowmya G]

Hi all! Happy New Year!!

We produce feed additives(RNA based) for aquaculture and planning to market in zone 4a&b countries.

I have three questions to clarify.

1. Can pilot batch (small batch size) be produced/used for all 3 batches of stability study
Since I work in a start-up, production costs can have huge impact so is it possible to only produce batches in smaller quantity for stability study use?

2. Is repacking/reconstituting into smaller sizes i.e. reconstituting as 100mg in small vials from 500g container is allowed for stability study during storage?
I am aware that the product should maintain the final packaging material used to market but does reconstitution have any effect on data?

3. Since this is not for human use, should the active ingredient also be included for long-term study? if yes, how many batch(es) should be used along with the final product?

Also can anyone explain how to do validation for test parameters.

Thanks.

 

[Johnnymo62]

How is this not for human use? The final customers will be human.

 

[Sowmya G]

How is this not for human use? The final customers will be human.

These are aquaculture products for fish and shrimp.

 

[Johnnymo62]

These are aquaculture products for fish and shrimp.

That are eaten by humans.

 

[Sowmya G]

Yes, but the primary user/consumer is aquatic animals. It is not intended for Human use.