Shelf Life Validation for Dietary Supplements (Probiotics, Vitamin C, Enzymes)

Hello everyone,

I am wondering if someone can help. 

I am working in a supplement manufacturers. Most raw materials are stable with the exception of probiotics, vitamin C and enzymes.

How would we go about validating our shelf life? We are not sure where to begin.

Thank you!

Shelf life of raw materials or the products you manufacture? 

The products we manufacture.

Do you only blend your raw materials or do you do any processing or add any preservatives that might change the shelf life of these materials?

We do both. 

Similar type of products here. Our shelf life is between 12-15mo and ingredients shelf life is on average 18-24mo.

Is it a new company or have you been manufacturing for a while? I would start with a safe time limit, like around 12mo, if this makes sense according to your raw materials average age when you pack it.

I would then send samples for monthly analysis when they hit this mark of 12 months old and keep monitoring the stability until you hit a shelf life time that is suitable for your company. 

You will probably have a case of 'Best Before' and not 'Expire' date.

I'm not sure if BRCGS has any specific requirements for how you determine it though....