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What are the terms GMP and cGMP?

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TecnicoCarla

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Posted 24 February 2023 - 11:15 AM

Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks



Charles.C

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Posted 24 February 2023 - 12:48 PM

Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks

Hi TC,

 

Maybe try googling cGMP - It's American.


Kind Regards,

 

Charles.C


Sayed M Naim Khalid

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Posted 24 February 2023 - 05:20 PM

In food sector GMP and cGMP are not a lot different. But if you are working on pharmaceuticals or nutraceuticals, you may need their relevant cGMP. I would recommend that you read cGMP based on the FDA codes so you can be fully compliant. 

 

You can read more about cGMP for drugs in the following FDA codes: 

  • Title 21: CFR Part 314
  • Title 21: CFR Part 210
  • Title 21: CFR Part 211
  • Title 21: CFR Part 212
  • Title 21: CFR Part 600

 

For food I would mostly consider GMP in other countries and in the US go to the following cGMP is needed: 

  • Title 21: CFR Part 117 sub part B (Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food)


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G M

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Posted 02 March 2023 - 10:06 PM

Hi everyone!!
Someone could give me some information about cGMP? I have a Spanish client that exports his products to EU and US. He would like to obtain the GMP+ certification but I think for EU he'll need cGMP. Can anyone give me some advice??? thanks

 

If cGMP came up, I'm going to guess this is a potentially FDA regulated (non-meat) food item?  The FDA in its infinite wisdom tried to reinvent the wheel in regards to a variety of food safety terms and principles after the FSMA.





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