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Raw material specifications

specifications

Best Answer Herman_Louw, 02 May 2014 - 07:43 AM

I think that haveing a declaration of compliance and technical sheets from suppliers on file on site is enough.

I think "suitable specifications" is the industry minimum standards for a specific raw material

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#1 GMP Packaging Industries

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Posted 01 May 2014 - 08:45 AM

The need of suitable specifications is well described in chapter 3.7 of the standard.

Regarding raw material specifications, what is understood as suitable specifications? Is it necessary to have an specific document for them? or is it enough if declaration of compliance and technical sheets from suppliers are available for all raw materials?

I am considering this issue as a flexible film manufacturer.

Thank you for your contribution!

 


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#2 Herman_Louw

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Posted 02 May 2014 - 07:43 AM   Best Answer

I think that haveing a declaration of compliance and technical sheets from suppliers on file on site is enough.

I think "suitable specifications" is the industry minimum standards for a specific raw material


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#3 GMP Packaging Industries

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Posted 20 May 2014 - 10:59 AM

Thank you very much for your feed back!


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#4 neilmilvain

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Posted 23 May 2014 - 02:39 PM

A declaration of compliance is a legal requirment for supplying packaging material into the EU.

As the manfacturer of the finished packaging material you will be required to have a specifcation in place for the materials you are using to demonstrate that your finished products meet the requirments of EU10/2011.

A specifcation can be simply the DoC and data sheet however you should consider developing your own specifcations for the raw materials.


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Neil Milvain
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#5 Peter Snopko

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Posted 29 May 2014 - 12:23 AM

I think you have missed something here.

 

You also need supporting evidence to show the Food Safety Compliance statements are correct. 

 

How many countries are you sending the packed product to? Each has its own requirements for heavy metals, banned substances and migration limits. These all need to be tested and test results submitted as part of the supporting evidence.


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www.prd.net.nz
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#6 Charles.C

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Posted 29 May 2014 - 06:03 AM

I think you have missed something here.

 

You also need supporting evidence to show the Food Safety Compliance statements are correct. 

 

How many countries are you sending the packed product to? Each has its own requirements for heavy metals, banned substances and migration limits. These all need to be tested and test results submitted as part of the supporting evidence.

 Dear Peter,

 

You are undoubtedly, genericaly,  correct from a safety POV however the legislatory implementation of  this logic can be distinctly variable in global terms. Commercial pragmatism ? :smile:

As usual, it only takes one calamity and everything changes, well, sometimes. One of the limitations of HACCP and QA in general.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#7 neilmilvain

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Posted 29 May 2014 - 06:13 AM

I think you have missed something here.

 

You also need supporting evidence to show the Food Safety Compliance statements are correct. 

 

How many countries are you sending the packed product to? Each has its own requirements for heavy metals, banned substances and migration limits. These all need to be tested and test results submitted as part of the supporting evidence.

This might be the case for some teritories but in the EU it isn't.  The directive is very clear, there is no requirement for testing to be conducted by the manufacturer/converter.  The suitability of the material can be established based on the provisionn of adeqaute evidence from the raw material suppliers.  Check article 32 of EU10/2011.

The directive requests that the supporting evidence for the decalration be made available and that it MAY include test data.


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Neil Milvain
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