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FDA's cGMPs: Should We Address Every Sentence?

FDA GMP cGMP

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#1 ladytygrr

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Posted 21 July 2015 - 07:31 PM

Hi everybody,

 

I am documenting our GMPs and, for simplicity sake, am choosing to base them, for now, on the FDA's cGMPs (21 CFR Part 110). But I have a couple of questions:

 

1) Should we address every sentence in 21 CFR Part 110? For example, part A of the Equipment section is below and it is this section that made me ask this question. I understand that GMPs can be addressed by multiple SOPs and SOPs can address multiple GMPs/GMP requirements but I don't know how I would document/prove that we are doing the first sentence below: isn't that something that can be proven out by a simple visual review of our production floor?

 

All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.

 

2) In the text above, the following statement made my eyes cross with confusion: "Food-contact surfaces shall be corrosion-resistant when in contact with food." WTH is that? So...they can be corrosive from 5 pm to 6 am when they're NOT in contact with food. Can somebody, pretty please, help me understand this sentence? I really do NOT like feeling this stupid.

 

Lastly, we are moving toward SQF L2 certification and I know that there are something like 12 GMPs that need to be addressed but I thought starting with the FDA's cGMPSs would be good since we're documenting/implementing HACCP before moving to SQF. So, am I right? Is this a good place to start for now? I don't want to split my attention between HACCP and SQF, particularly since I haven't been through SQF Practitioner training yet but don't want to put myself in a position where I have to re-write everything, either. It's also not fair to our floor employees to get trained on X things and then 3 months later change it all up on them. 

 

Thank you!

 

~Emily~


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#2 ChocoTiger

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Posted 21 July 2015 - 07:59 PM

ladytygrr,

 

Yes, a visual inspection would cover the quoted CFR during an SQF Audit.  In addition, listing the equipment, machinery and utensils in your Sanitation SOP(s) and on the related forms will show that these items are in fact cleaned, and on a set schedule.  For SQF, having an MSDS (or equivalent) form for the utensils would be useful, so the auditor can confirm that they are made of food grade materials.  You should be able to get this from your supplier, if it doesn't come with new utensils when you order them. 


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#3 ladytygrr

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Posted 21 July 2015 - 08:16 PM

For SQF, having an MSDS (or equivalent) form for the utensils would be useful, so the auditor can confirm that they are made of food grade materials.  You should be able to get this from your supplier, if it doesn't come with new utensils when you order them. 

ChocoTiger,

 

Thank you for your reply. I was good until your last 2 sentences which made me say "Wwwhhhoooaaa...MSDS for utensils?!" I've not heard of that before. Double thanks to you for that tip. 

 

 

We do list the equipment, machinery, utensils, etc. in our SSOPs and SOPs but not all of it is by name. We call things, for example, the Flow Wrapper rather than whatever it's brand and technical name are. And for the utensils, we just say "utensils", we don't name them "spatula", "spoons", etc. - Do you think that will suffice or should we be putting the formal brand/name in our documentation?

 

Thank you!


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#4 ChocoTiger

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Posted 21 July 2015 - 08:47 PM

No, you wouldn't need the brand names in your documentation, but having specific utensil names would be good for inventory tracking, and your Glass and Hard Plastic Policy (SQF 11.7.5, 11.7.6, and 11.7.7(Foreign Matter Contamination)).


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#5 johntstuart

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Posted 21 July 2015 - 09:31 PM

"Food-contact surfaces shall be corrosion-resistant when in contact with food."

 

I have always understood this sentence to mean that the food equipment shall be made of a material that is resistant to the corrosion that may come from your food during your food manufacturing process.  For example, if you are processing a high-acid food (like tomatoes), your equipment should be made of a material that resists acid corrosion (stainless steel for example).


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