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Is a repacker a manufacturer? And what is the difference between a processor/re-processor?


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#1 aureliew

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Posted 29 June 2020 - 12:16 PM

Hi all, 

 

we are a manufacturer and trader of minerals to be used for food supplement, currently FSSC22000 accredited (B2B only). 

we are trading some food products and sometimes we have to repack them, mainly in a bag closed with cable tie in a box or drum. During the repacking, we are sieving through 1mm the powder before introducing it into the new bags and sealing them.

 

I cannot seem to find any clear guidance on this in FSSC docs. I've checked BRC v8 and the only thing that I could find was within the glossary for manufacturer: "a packer that packs product into retail units from bulk-supplied material can also be classed a manufacturer". FDA also states that : "Generally. FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug" . this does match with what we are doing except that it's really guided to pharmacies or pharma applications.

 

do you  know if we can be classed as a manufacturer for our repacking activities?

what is the difference with a processor/re-processor?

thank you for your help.

 

Aurélie 



#2 Disco D

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Posted 08 July 2020 - 09:07 PM

You might want to look into seeing if you are right for an exemption

Other wise i would follow the same guidelines as a packaging company and for sure have a top priority in you documentation , labeling and transportation for a possible recall . Make sure you have and follow that policy and GMPs ..   



#3 Charles.C

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Posted 09 July 2020 - 04:13 AM

Hi all, 

 

we are a manufacturer and trader of minerals to be used for food supplement, currently FSSC22000 accredited (B2B only). 

we are trading some food products and sometimes we have to repack them, mainly in a bag closed with cable tie in a box or drum. During the repacking, we are sieving through 1mm the powder before introducing it into the new bags and sealing them.

 

I cannot seem to find any clear guidance on this in FSSC docs. I've checked BRC v8 and the only thing that I could find was within the glossary for manufacturer: "a packer that packs product into retail units from bulk-supplied material can also be classed a manufacturer". FDA also states that : "Generally. FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug" . this does match with what we are doing except that it's really guided to pharmacies or pharma applications.

 

do you  know if we can be classed as a manufacturer for our repacking activities?

what is the difference with a processor/re-processor?

thank you for your help.

 

Aurélie 

Hi Aurelie,

 

A related query occurred  previously and seems to have failed to be resolved -

 

https://www.ifsqn.co...pe/#entry101599

 

I did notice these 2 "related" comments in some fssc22000 documentation but their interpretation for your own query (if any) is not entirely "clear" to myself -

 

Part 1 – Scheme overview

The following scopes are added: Transport and storage services, Catering, Retail and Several new reference documents were added: ISO/TS 22002-6 PRP’s for animal feed, ISO/TS 22002-2 for catering, BSI PAS 221– PRP’s for retail and NEN NTA 8059 – PRPs for transport and storage. This broadens the scope of the scheme and even makes way for the retailers to lead the way in certification – wonder when that will happen!

The good news is that distribution centres and other distribution companies can now join the party. The following examples would fit the new scope:

  • Organisations specialised in transport and storage services (eg products are handled by organisation but legally owned by its customer)
  • Product are legally owned by organisation and handled by own transport and/or storage facilities (eg packing / repacking activities without altering the product or its primary packaging)
  • Transport & storage activities of certified manufacturing organisations do not need a separate certification unless required explicitly by its customer

 

https://www.foodstuf...nounced-audits/

 

Attached File  repack.PNG   23.57KB   0 downloads

 

Attached File  fssc22000 guidance document on certification scope,2014.pdf   190.06KB   1 downloads

 

 

The above look fairly encouraging..

 

One simple option which would probably be free-of-charge would be to ask yr existing auditing Company. :smile:


Kind Regards,

 

Charles.C





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