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FSMA HARPC - Hazard Analysis for unintentional hazards?

FDA FSMA HARPC

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#1 joseangp

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Posted 11 April 2016 - 02:45 AM

Hello guys,

 

I'm working in a RTE mfg facility in Mexico and we're getting ready for FSMA.

One of the requirements is developing a Hazard Analysis for both naturally occurring hazards (I'm understanding this is basically HACCP, right?) and unintentionally introduced hazards (controlled by prerequisites).

 

I was wondering if you have developed a Hazard Analysis to define frequencies of monitoring, verification and validation for every single prerequisite?

What is FSMA requesting to comply with the Hazard Analysis for unintentional hazards?

 

Thanks in advance.


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#2 John_E

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Posted 06 May 2016 - 02:47 PM

Good question.

According to 21 CFR 117.135 "Preventive Controls", controls must be appropriate (duh), written, and you must identify the parameters (min, max, etc.).

 

Next if you go to 21 CFR 117.140 "Preventive Control Management Components", it states the controls are monitored, have corrective action plans, are verified, records are reviewed, and are reanalyzed.

 

So in short: yes.

 

I view the whole HARPC thing as just HACCP but you now have to validate and monitor your prerequisite programs like you would a CCP.

 

-John


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#3 Charles.C

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Posted 06 May 2016 - 04:12 PM

Hello guys,

 

I'm working in a RTE mfg facility in Mexico and we're getting ready for FSMA.

One of the requirements is developing a Hazard Analysis for both naturally occurring hazards (I'm understanding this is basically HACCP, right?) and unintentionally introduced hazards (controlled by prerequisites).

 

I was wondering if you have developed a Hazard Analysis to define frequencies of monitoring, verification and validation for every single prerequisite?

What is FSMA requesting to comply with the Hazard Analysis for unintentional hazards?

 

Thanks in advance.

 

Hi jose,

 

I think you are getting a little confused.

 

It's a new world courtesy of FDA..

 

CCPs bye-bye

PRPs bye-bye.

PCs - Welcome !

 

I suggest you have a search/look at the prototype FSPCA/harpc training manual now available to download, and also attached on this forum by kellio..

Plus the example harpc hazard analysis posted on this forum by mgourley.


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Kind Regards,

 

Charles.C


#4 joseangp

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Posted 07 June 2016 - 08:16 PM

Hey guys! Thanks for your responses, I'm now a PCQI, so I've got a much accurate understanding than before (so I reviewed the Manual with the trainer).

We've made adequacy to our Hazard Analysis (and have our monit, verif, valid, CA, record reviews, etc) in order to comply with the requirements.


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