2 Comments

  1. james@enzymeprocess.co' James
    April 6, 2017 @ 1:52 pm

    Dr. Michelle, Thank for your showing my company Enzyme Process. I am not sure people understand what “pharmaceutical grade” actually means. There is no legal definition for pharmaceutical grade. The best term to use is U.S.P. compliant. U.S.P. (United States Pharmacopeia) is the standard by which drugs are manufactured. Many supplement manufacturers adopt the USP as their standard. It is vitally important that your manufacturer uses the USP as their reference for manufacturing and testing. Even if there is a so-called “third party” test result, if the lab is not following the USP the results are meaningless.
    Dr. Michelle is correct that you should use only GMP certified manufacturers. You should always ask for a copy of the GMP certificate with the company name, dba if using, and the date. If these are not on the certificate it may be fake.

  2. ldarjania@cox.net' Levan Darjania, PhD
    November 4, 2017 @ 6:40 pm

    General question:
    Does those dietary supplement GMP certified companies (supposingly compliant to 21 CFR part 111 regulation) use GMP cerified raw materials (herms, oils, etc.) for the production of their finished products?
    in other words, if the finish product manufacturer (formulator) is fully GMP compliant, but the raw material is not GMP grade – will the finished product qualified as GMP grade?
    Thanks
    Levan

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