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FDA-FSMA,GRAS Status Glass Manufacturing Plant


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#26 LauraIsaiah

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Posted 12 April 2019 - 04:03 PM

Composition

Silica sand, Quartz Powder, Soda Ash, Limestone Powder, Calcite powder, Dolomite powder, Feldspar powder, Spodumene, Sodium sulphate, Sodium Nitrate, Selenium powder, Zinc Selenite, Cobalt Oxide, Aluminium Hydrate, Coke powder, Iron Oxide, Iron Pyrite, Calamite, Potassium carbonate, Barium carbonate, Borax, Cullet

The simple process is: mix, melt, blow mold, anneal, coat if needed per customer, pack. That's the simple version there is alot of course that goes into it.



#27 LauraIsaiah

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Posted 12 April 2019 - 04:08 PM

We do two types of lab testing both on raw materials and the actual glass after production, which includes heavy metal testing along with several other things.



#28 Jpainter

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Posted 12 April 2019 - 04:31 PM

LauraIsaiah, 

 

Going back to your original question, I believe you are correct in thinking that per FDA you will only be subject to 21 CFR 117 subpart b. However, like you mentioned for GFSI certification you need to go above and beyond. As per AIB  who is a certifying body for BRC, the following is needed for a food packaging manufacture to become BRC certified. Management commitment statement or policy, hazard and risk assessment, Quality Management Systems including product traceability and management of recalls, The site environment and operating standards: including product storage, maintenance, cleaning, pest control, equipment, and security and lastly, Personnel training and hygiene requirements. Here is a link to where this information was pulled from. 

 

https://www.aibonlin...n/BRC/Packaging



#29 Charles.C

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Posted 12 April 2019 - 05:58 PM

afaik the current target is for fssc22000. This is a private FS Standard, not related to FDA , except possibly where fssc requirements are equivalent.

 

fssc2200  IIRC specify the requirements in detail for "Packaging" on their website.

 

There are some (at least one anyway) examples here where conventional packaging manufacturers applied for certification to above standard.

 

A formal haccp plan etc was required (similar to BRC Packaging-safety except implemented for iso-haccp) as per iso22000 Standard plus, presumably, a response to iso22002-X Standard for Packaging. (This was reason my asking about Product specifications).

 

The GRAS aspect is obviously material-ingredient-product oriented but other contamination possibilities involve the specific process/environment.

 

To what extent yr existing FDA/GMP CFR-driven Procedures correlate to iso22002-X I have no idea.


Kind Regards,

 

Charles.C


#30 LauraIsaiah

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Posted 24 April 2019 - 02:59 PM

I took the suggestion to call the FDA and was told we are exempt from the FSMA law and are considered GRAS by them. Now to determine if going after the food safety certification is worth it, we already have the ISO 9001:2015 certification and have a strong cGMP program.



#31 Scampi

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Posted 24 April 2019 - 04:22 PM

The certification will allow you to shop for more customers.............alot of companies WILL NOT accept materials from a supplier without it!


Because we always have is never an appropriate response!





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