8 replies to this topic

[Omoware]

Hi all, I am conducting internal audit and I am not sure what BRC expectation is regarding clause 5.1.3: "Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality." Any help will be greatly appreciated!

[zanorias]

Hi Omoware,

 

Validation i.e micro/organoleptics/ testing appropriate for your product etc based on product made as it will be done in the factory.

 

The Interpretation Guide clarifies it a bit (worth getting a copy if you don't have one already)

 

Factory trials
Documented evidence of production trials (i.e. not kitchen-scale trials) needs to be available, together with
test results validating that the product formulation and manufacturing processes are capable of producing
a safe product of the desired quality.
Factory trials may not be required where new products are very closely based on existing products.
Where production trials are not undertaken, the reason must be documented.

 

Hope that helps

[Omoware]

Thanks so much!

 

It helps a lot! I will look in to getting the interpretation guide.

 

Appreciated.

[olenazh]

Doesn't 5.1.3 say about product/process validation? If you need to validate product/manufacturing process you need to conduct a plant trial, using production equipment - and that validation is done to make sure your product formulations and manufacturing processes are capable of producing safe products.

[zanorias]

Thanks so much!

 

It helps a lot! I will look in to getting the interpretation guide.

 

Appreciated.

No worries.

You can get the Interpretation Guide from the BRCGS bookstore (£125), or download for free from Participate if you are already BRC certified.

[Charles.C]

No worries.

You can get the Interpretation Guide from the BRCGS bookstore (£125), or download for free from Participate if you are already BRC certified.

One would have thought that shelf life trials would have directly answered this typically ambiguous BRC clause

[Xenna]

Doesn't 5.1.3 say about product/process validation? If you need to validate product/manufacturing process you need to conduct a plant trial, using production equipment - and that validation is done to make sure your product formulations and manufacturing processes are capable of producing safe products.

 

When the test is carried out at the factory, we will obtain a product (test batch, for example)

What should be done with this batch? Can we commercialize or should this product remain segregated and be used as a reprocess in the next productions?

[olenazh]

We've been having a lot of those tests/trials, and usually we don't sell the products as they're packed in the blank packaging. We don't use reprocessing as well - so, that stuff eventually goes to garbage, unfortunately. However, you could re-process PT products if it's your usual practice - depends on your product & process nature...

[pgov]

Hi

 

Would anyone happen to have an example of a factory trial report for production please?