Co-Manufactured Product Shelf Life

Hi. Im here with daunting questions again.

Recently a co-manufacturing project with another company has just kicked off. My factory here will be producing wafers under their brand name.

I am wondering, since the expiry date and major ingredients are set by their company (we do not know how they determine the period for their expiry date nor what their ingredients are), therefore am i required to send their product for shelf life test? In my opinion, if either one of us performed the shelf life test, that would suffice.

I confronted them in a discussion but it seems they will not be able to share their test reports for shelf life.

My logic tells me that since my company only manufactures the products and all other factors are pre-set by their company, it means that my company is not held responsible if anything goes wrong.

But my experience tells me that that reason will not satisfy the auditors.

Please help!

Regards,
Eugene.

hi eugene,
if i were in your position , i would insist on the expiry date that i find appropriate and usually work upon on my other formulas and products.

I would have insisted on an appropriate expiry date too, but they have set the date themself without enquiring advice on the expiry date.

The manufacturing has since commenced.

On this topic, i have requested that they send a copy of the report for shelf life test to our company.

Reg,
Eugene

Dear Eugene,

Seems like a good example of "When is a validation not a validation?"

I have met 2 variations of yr problem. If the auditor is nice (well-fed, admires J.Bond , and not hunting for [further?] problems) and yr customer is a "big boy", a xref to an official looking statement of their date requirement may work.

(obviously it helps if the numbers themselves are demonstratably credible with respect to other related market products )

If not, you may be politely requested to explain the source's procedure with data (or published links). This is sadly invariably difficult to get IMEX.

Good luck,

Rgds / Charles.C

Hi,

Thanks for your feedback on this matter. Now that i did some memory jogging, a similar problem did occur when a customer specially requested to have their shelf life be extended beyond our shelf life period. When it comes to time for auditing, the auditor was satisfied to see an undertaking letter from the customer stating that they will be responsible for this modification.

This would not guarantee product safety, but it could save my ass. Come push and shove, I would probably do it that way.

Regards,
Eugene

Hello Eugene,

I think you have the reply, go and audit them! If you are one of their customers, they won't deny it!

I remember 3 years ago I asked a big firm which sells a lot of food products in France to give me some microbiological analysis, and they weren't able to do it...I required them, they required all the analysis of their suppliers, and eventually I succeed in having them...3 months later! That was the first time a factory required them - maybe because of the size of this firm...

Best regards,

Emmanuel.

The thing is, they are paying me to manufacture products for them, so i think im playing the customer role instead.

The advantage is, they are an international big player in the food industry with their own standards that are acknowledged worldwide. With this i was hoping their reports for shelf life tests that are done internally can be recognized by my food auditors.

Its just that they dont seem to want to share the report and i dont want to waste the additional resources to send it for external shelf life test.

Regards,
Eugene

Who is assembling and selling the finished product that I am assuming your wafers are a component of?



If it is their product and they have pre determined the shelf life then it is up to them to prove how they arrived at that date.

If you are saying they ask your company to assemble a finished product to their specification then it is also their responsibility.

If however you are using their product combined with your own to create a finished product under "your" brand then it is your responsibility to be able to demonstrate shelf life determination.

It is a combined product. Both of the companies contributes some parts to the wafer. The product specifications are set by their side though.

However, it is marketed only under their brand name.



PS: They have agreed to share their test reports

Regards,
Eugene