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Allergen Validation Study

Started by , Jul 10 2018 01:59 PM
9 Replies

Hi all,

 

looking for a good form to conduct a validation study.  We recently had our BRC Audit, and got a minor non conformance for not having a allergen validation study completed.  I understand expectations, but do not have a good format to document the validation study.  We use Neogen Allergen kits.

 

will someone please provide me with an example of a validation study for allergens. 

 

Thank you,

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Hi all,

 

looking for a good form to conduct a validation study.  We recently had our BRC Audit, and got a minor non conformance for not having a allergen validation study completed.  I understand expectations, but do not have a good format to document the validation study.  We use Neogen Allergen kits.

 

will someone please provide me with an example of a validation study for allergens. 

 

Thank you,

 

Maybe also watch the replies to this adjacent thread -

 

http://www.ifsqn.com...dy/#entry128123

Hi all,

 

I need to complete an allergen validation study, and I need to document it .  Does any one have a form or document they would be willing to share? also need a little direction.  we are a bakery, and we have wheat as a common allergen as well as soy and dairy.  ihave the neogen kits to swab, just need documentation and direction to get started. 

 

Thank you,

 

Marv

Let me see what I have template wise. In the meantime, are you only performing the Neogen Reveal 3D? Do you also use their Veratox/Alert (ELISA method)?

Hopefully these documents helped. I created a basic verification of allergens using reveal 3d. Other documents explain veratox procedure and others.

Attached Files

8 Thanks

I have attached other documentation from Emport LLC concerning their allergen testing kits (includes val. studies). See attached.

Attached Files

5 Thanks

Added allergen best practices document

Attached Files

6 Thanks

Hi all,

 

I need to complete an allergen validation study, and I need to document it .  Does any one have a form or document they would be willing to share? also need a little direction.  we are a bakery, and we have wheat as a common allergen as well as soy and dairy.  ihave the neogen kits to swab, just need documentation and direction to get started. 

 

Thank you,

 

Marv

 

Hi MBrown042

 

I am in the same situation. Did anyone supply you with a template you used on this? or do you have one you can share?

I not sure on how best to document this. 

 

Thanks Caz

We use Neogen test kits to verify changeover of allergens. Annually I do testing on on equipment after changeover sanitation to send to 3rd party lab, ELISA (BioFront/AS-CC-016). Once results are returned to me, I am able to write my report. This is my validation method. I am validating that the sanitation is sufficient during changeover and my Neogen testing is sufficient to the release the equipment back into production.

 

I write all my steps and methods and give conclusion. Its a relatively simple validation compared to others. It has been fine during SQF auditing.

Hi MBrown042

 

I am in the same situation. Did anyone supply you with a template you used on this? or do you have one you can share?

I not sure on how best to document this. 

 

Thanks Caz

4-year old thread. Answer may be delayed.

 

 

Also see this current parallel related query -

 

https://www.ifsqn.co...ss/#entry184120


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