cGMP Requirement for Dietary Supplement
Hi There,
Amazon Dietary Supplement requirement for cGMP is as follows:
Product was manufactured in a facility compliant with cGMPs in accordance with requirements outlined in 21 CFR 111/117 or equivalent
Accepted GMP programs include but are not limited to the following: Eurofins GMP, NSF/ANSI 455-2, 229 GMP, UL GMP, USP GMP, SAI Global, SGS, Intertek, TGA, SQF Dietary Supplements Food Safety Code, GFSI, and SSCI.
GMP must be performed by an accredited third-party. Private audits, first-party audits, consulting audits, FDA inspections, and ISO standards will not be accepted. The GMP certificate must be in good standing and cannot be expired.
Q1: Does Amazon require GFSI recognized certification schemes like FSSC 22000 or BRCGS?
Q2: Would a cGMP certificate from an accredited body/third party be sufficient?
Because the requirement for a cGMP and FSSC22000 is very different, FSSC 22000 being more in-depth and complicated than just a cGMP.
Q3: What would constitute a third party? Can a local government certify my cGMP and would that be approved?
cGMP Requirement for Dietary Supplement
Hi There,
Amazon Dietary Supplement requirement for cGMP is as follows:
Product was manufactured in a facility compliant with cGMPs in accordance with requirements outlined in 21 CFR 111/117 or equivalent
Accepted GMP programs include but are not limited to the following: Eurofins GMP, NSF/ANSI 455-2, 229 GMP, UL GMP, USP GMP, SAI Global, SGS, Intertek, TGA, SQF Dietary Supplements Food Safety Code, GFSI, and SSCI.
GMP must be performed by an accredited third-party. Private audits, first-party audits, consulting audits, FDA inspections, and ISO standards will not be accepted. The GMP certificate must be in good standing and cannot be expired.
Q1: Does Amazon require GFSI recognized certification schemes like FSSC 22000 or BRCGS?
Q2: Would a cGMP certificate from an accredited body/third party be sufficient?
Because the requirement for a cGMP and FSSC22000 is very different, FSSC 22000 being more in-depth and complicated than just a cGMP.
Q3: What would constitute a third party? Can a local government certify my cGMP and would that be approved?
2 replies
Emet_Amazon
Hello @Seller_VsHl8PSpHGa8S,
Thank you for posting your concerns surrounding compliance documentation.
Product was manufactured in a facility compliant with cGMPs in accordance with requirements outlined in 21 CFR 111/117 or equivalent
Accepted GMP programs include but are not limited to the following: Eurofins GMP, NSF/ANSI 455-2, 229 GMP, UL GMP, USP GMP, SAI Global, SGS, Intertek, TGA, SQF Dietary Supplements Food Safety Code, GFSI, and SSCI.
GMP must be performed by an accredited third-party. Private audits, first-party audits, consulting audits, FDA inspections, and ISO standards will not be accepted. The GMP certificate must be in good standing and cannot be expired.
As you seem to already be aware of our dietary supplements policy, here is our help page on the subject which offers the same requirements but also a little more more information specific details. I have additional reached out to our community managers to review the situation and follow up if they can offer more guidance for your situation.
If you have any cases surrounding the request or submissions, I would recommend providing them here for additional review.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
Josh_Amazon
Hello @Seller_VsHl8PSpHGa8S,
Thank you for contacting our Forums!
Following up on this thread, any seller that have more information or that are experienced on this topic are welcomed to comment and post to contribute to the conversation.
I would also suggest to contact our Seller Support team so they can provide support with the questions you have. You can contact them through the following link:
Kind regards,
-Josh
