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Allergen Validation Study

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MBrown042

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Posted 10 July 2018 - 01:59 PM

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,



Charles.C

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Posted 10 July 2018 - 02:24 PM

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


Kind Regards,

 

Charles.C


MBrown042

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Posted 10 July 2018 - 02:28 PM

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


Edited by Charles.C, 10 July 2018 - 05:14 PM.
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jdpaul

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Posted 10 July 2018 - 04:14 PM

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)?


Edited by Charles.C, 10 July 2018 - 05:14 PM.
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jdpaul

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Posted 10 July 2018 - 04:39 PM

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

Attached Files


Edited by jdpaul, 10 July 2018 - 04:40 PM.


jdpaul

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Posted 10 July 2018 - 07:02 PM

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

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jdpaul

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Posted 10 July 2018 - 09:13 PM

Added allergen best practices document

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cazcazcaz

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Posted 25 March 2022 - 01:34 PM


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



wtheriot

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Posted 25 March 2022 - 08:52 PM

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.


Edited by wtheriot, 25 March 2022 - 08:53 PM.


Charles.C

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Posted 26 March 2022 - 08:37 AM

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


Kind Regards,

 

Charles.C




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