Dietary Supplements cGMP
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.
Is it a requirement for the cGMP certifying organization be from the following list mentioned above? My manufacturer is overseas and there are limited GMP cert organizations domiciled there. Does the policy permit any accredited organization or does it have to be from the orgs explicitly mentioned?
Dietary Supplements cGMP
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.
Is it a requirement for the cGMP certifying organization be from the following list mentioned above? My manufacturer is overseas and there are limited GMP cert organizations domiciled there. Does the policy permit any accredited organization or does it have to be from the orgs explicitly mentioned?
1 reply
Michelle_Amazon
Hi @Seller_Aouq4u2DLjE1k,
I understand that you are wondering if other labs are accepted, and the answer is yes.
Per the help page:
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.
Unfortunately, I can't tell you if your specific lab is approved, but as long as it conforms with the policy, it should be accepted.
Please let me know if you have any other questions.
Regards,
Michelle
