I would say that to "demonstrate that utilities and equipment are suitable for their intended use and perform properly" would be a key phrase in this type of assessment with respect to US FDA.
This (http://www.fda.gov/f...e/ucm188064.htm) talks about food equipment requirements in general.
Although it is written for drugs, it's possible that much of the following document would be general enough to apply to food as well. http://www.fda.gov/d...s/UCM070336.pdf
Thks for the input.
This is rather OT but since you are in the USA, may i pose a specific query ?
Suppose you are purchasing a system for canning product X, what kind of equipment documentation do you "officially" require from the equipment supplier to then be able to propose your intended process to USFDA for further approval (I believe this is the basic procedure required).
I suspect the answer will simply be a document from equipment suppplier (or perhaps a link to NSF specific approved model) couched in the general, ie non-binding, terms of yr first paragraph. However the possible requirements are in theory wider, eg this example discussing differences between COC/COA -
In terms of SAP there is none. The terms refer to the content provided in a certificate that is delivered to yoru company by a vendor for a product or a certificate that you send out when you sell a product.
A COC or Certificate of Compliance is usually very simple and contains minimal information. It usually has header info about the product or batch and maybe some delivery info. That is usually followed by a statement that says something like "This product meets all requirements of specifcation XYZ and is approved for import use as a xxxxxxxx to the EU". Or whatever the heck your product complies with. It may be provided with non-batch managed material or batch managed material, or serial numbered product.
The COA or Certificate of Analysis is more complicated and while it may also have similar statement as the COC, it also usually contains specific analytical data that is specific to a batch or serial numbered product. It may list multiple batches each with their own set of data. The headers of a COA and a COC can be virtually identical.
In SAP, you can create as many certificate types as needed, some might be COC's, some might be COA;s. Your company might receive in both COA's and COC's and your company might send out both COAs and COC's.
I noted (to my surprise) that above example text does imply that documents guaranteeing "blanket" import capabilities (eg to EU) are apparently in common usage/available so the OP may not be so unexpected in reality. I guess business is business.
Rgds / Charles.C
PS - just to further illustrate the semantic opportunities, i noticed these 2 definitions while browsing -
Certificate of Analysis (COA) is a record of quality control testing performed for the product/ material which indicates whether the product or material conforms or not.
The Certificate of Compliance (COC) is a record that everything which was performed as a part of manufacturing that material or product has been verified and was found to be in compliance to all its written procedures (batch instructions, written procedures).
Welcome to the World of Gobbledegook, aka Business !