3 replies to this topic

[TecnicoCarla]

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]

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.

[Sayed M Naim Khalid]

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)

[G M]

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.