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Acidified Filing Inquiry by FDA

acidified filing

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#1 svnh.bell

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Posted 03 April 2017 - 02:27 PM

Hi all, 

 

I'm looking for some feedback from anyone well versed in acidified filing. I will lay out our current situation below: 

 

We produce an oil in water dispersion. When performing the challenge study for the product, our Process Authority wanted only the water phase of the product to challenge. The pH of the water phase was ~3.50. The finished product pH is ~3.8 when the oil phase is added. I filed the process with the challenge study and listed our equilibrium pH at 4.0 (spec is 3.8 plus/minus 0.2). We received an inquiry from the FDA stating that the product could not be filed at a pH higher than that of the control used in the challenge, which makes complete sense. The Process Authority stated at the time of the challenge that the water phase is the phase of microbiological concern, therefore that is all that should be challenged. The issue lies in the pH difference once the oil phase is added. Our Process Authority has offered to write a letter explaining the unique situation of the product to respond to FDA with. I see 3 potential pathways: 

 

1.) Submit the letter from the Process Authority with our own cover letter. 

2.) File at pH of 3.5 and measure/prove the the water phase pH is 3.5 if challenged.

3.) Re-challenge the finished product with oil phase. 

 

This product is set to be released to market very soon, we are in pilot plant trials. A challenge study would take 30 days minimum pushing that date back. 

 

Any insight or opinions would be greatly, greatly appreciated. Thank you. 


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#2 FurFarmandFork

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Posted 03 April 2017 - 05:05 PM

This is an amazing question, thanks for sharing with us! I've never been held to the acidified foods or LACF regs, so I'm unfamiliar with the details, but I'll try to weigh in.

 

Another option would be to repeat your water phase-only challenge study but with a modified formula at 3.8 or 4.0, if the water-only phase is successful there you could refile knowing that regardless of the final language you'll meet the measured pH both in the phase only and in the complete mixture and eliminate the need to explain the difference.

 

I think all of your options are good ones. Regarding your release timeline, if your data suggests that there's no consumer risk with your formulation (ethics first!), I would say ride the one you got on file while collecting additional study material so that you can improve on it going forward. It sounds like you've got your scientific defense together and I agree with getting it on a cover letter so that you have that ammunition when an auditor unfamiliar with your process comes by.

 

I think a piece missing to help drive your decision is how well your filing is going to keep with your HACCP plan and expected post-market surveillance. Does your pH CCP have critical limits established for the water-phase only as an intermediate step in the process, do you monitor once you have the final product, or do you separate the final product to just test the water phase? If you verify you met your target pH with the final product, your process filing should reflect that same critical limit for the same material, if you check it in the aqueous portion only, then your filing should reflect that so that results collected from the final product post-market don't find you non-compliant because they used a different sampling method.

 

I think what you're stuck with is that if you have a risk assessment/CCP based on the aqueous portion only, FDA has a reasonable point in performing post-market surveillance and finding a higher pH value, then asking the question (what if your oil portion was altered/contaminated somehow in a way where it affected the pH of the aqueous portion, how would you have known if the final pH was affected?

 

Sounds like you've got a good handle on the product and the filing, I think you're good to go, but should keep taking steps to make defending the formulation easier in the future.


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For discussions related to food safety, production, and agriculture. Check out my blog at http://furfarmandfork.com/.

 


#3 Ryan M.

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Posted 05 April 2017 - 01:57 PM

Option 2, file with the water phase specs and be ready to show your results that prove you are meeting this spec in water phase.  This is really the only option.  Can you put a process in place to monitor this during production and make it a CCP?

 

4 years of acidified food regulations under my belt.


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#4 svnh.bell

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Posted 05 April 2017 - 02:15 PM

Thank you for the feedback Ryan M. We use a batch system. So, the only way to verify pH is to batch the water phase, measure and record pH prior to adding the oil premix. My concern with this option is that the water phase doesn't represent the entire product. The pH of the entire product (water+oil phase) is the data recorded on the COA. This can easily be changed, however my initial thought was that when the Dept of Ag comes in for an acidified audit, they would not be satisfied with only verifying the pH of the water phase. How would I respond when challenged with, "Why are you only using the water phase as the pH control" during an inspection? 


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#5 Ryan M.

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Posted 07 April 2017 - 03:13 PM

Thank you for the feedback Ryan M. We use a batch system. So, the only way to verify pH is to batch the water phase, measure and record pH prior to adding the oil premix. My concern with this option is that the water phase doesn't represent the entire product. The pH of the entire product (water+oil phase) is the data recorded on the COA. This can easily be changed, however my initial thought was that when the Dept of Ag comes in for an acidified audit, they would not be satisfied with only verifying the pH of the water phase. How would I respond when challenged with, "Why are you only using the water phase as the pH control" during an inspection? 

 

In that case, I think it is best to measure and record pH for both phases.  You can use the final batched product pH as your COA pH, but call the water phase pH something like, "regulatory pH".  Hopefully this isn't too cumbersome.

 

By doing it this way you cover all your bases.


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