Raw materials used for NPD with an expired BBD advice please
Greetings all,
I have discovered today that we have a 2 raw materials that are dry and powdered by nature that have a BBD that has expired 1 yr ago and 2 yr ago. (yes i raised a corective action for this) I have asked for the material to be disposed of.
However the issue im faced with is that the company only uses this material for trials which they do not do very often and there telling me i can not dispose of it because the BBD is only going to be a quality related issued if used beyond BBD and can be used because trialed product would not be consumed.
Is there any advice on this? a piece of legislation that says we should dispose of it, as iv argued and argued al lday long on this one and cant seem to win. including why trial something using substandard raw material that may not perform the way fresh would.
Hi David, in my experience if it is uniquely coded and identified as trial material and perhaps stored away from normal raw materials to prevent inadvertent use then it is ok; as it is never meant to be used for commercial end products.
That said even as a trial material you need to make sure that it has the same properties as the original specification or as you say it is pointless to use it for trials. Is it sometimes possible to revalidate a raw material before use. Often packaging materials have an expiry date of 12 months, but can be used for many years more. The expiry date is often an arbitrary date given by suppliers to cover their butts.
Regards,
Simon
This is what i thought, but it does raise the question BBD 2013 on say a raw material but how long before the argument "its not used commercialy" do you keep it for. i mean LOL you could keep it untill next decade on that basis...
Hi David
We do something relatively similar, things to consider are :
The integrity of the actives or make up of the powder may have degraded, so i assume the R&D is for flow tests and binding with other powders.
We make absolute sure that the R&D material is clearly marked on the container and on our software planning/stock system and we make sure we absolutely depose of the material after the R&D has been validated
Hi David,
Personally I think that the aspect of trial materials is irrelevant. If it's expired, it's expired. Period.
As a partial OT, I have seen at least 2 food-related websites recently which state that the shelf life of a product containing mixed ingredients must be calculated based on the shortest slelf-life component.
IMO, R&D should follow the same constraints as Production.