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Stupid question of the day...... FSMA Expectations


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#1 scoot915

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Posted 22 September 2016 - 09:44 PM

Hello

 

I have gone to FDA website, googled and searched on IFSQN but can not find what I am looking for,

 

Is there a document available with FSMA expectations similar to the documents available for other standards?

 

Maybe I am just confused or looking in the wrong places...all I find are "final rules" perhaps I am supposed to figure out what to do from these?

 

Any help would be appreciated.

 

Thank you!

 

 



#2 mgourley

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Posted 22 September 2016 - 10:25 PM

The "guidance" documents from FDA were released in August. These are draft documents only, so they are only as useful as you wish to make them.

 

This page lists the current draft documents for the Hazard Analysis and Risk-Based Preventive Controls for Human Food. Unfortunately, the guidance that everyone is really seeking is "coming soon".

 

Marshall

 

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#3 scoot915

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Posted 22 September 2016 - 10:42 PM

Thank you for the info.

 

I thought "coming soon" was here already and I could not find it  :headhurts:



#4 mgourley

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Posted 22 September 2016 - 11:00 PM

Nope. You are as up to date as the rest of us.

I'm assuming when "coming soon" is here, the above link will have the info.

 

Marshall



#5 Ryan M.

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Posted 26 September 2016 - 08:24 PM

Even when the final guidance document, or implementation document, comes out it won't be like a checklist you can follow.  You will have to tailor it to the needs of your facility, process, and product.  You will have to ensure you follow the HARPC principles in doing so and be able to justify your verification and validation with as much science/technical information to support your programs.

 

In some ways FSMA goes beyond GFSI, but in other ways it is behind in rigors.






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