FAQs

From Dietary Supplements e-Newsletter - September 2009

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Q. I am currently applying for accreditation in my country with regard to the USP-NF dietary supplement standards. I have indicated to regulatory authorities that the USP methods are validated methods. However, to what extent are the methods validated and were can I find the documentation/validation reports?

A. USP analytical procedures are validated by the sponsors or by USP in accordance with USP General Chapter <1225> Validation of Compendial Procedures, which has been the cornerstone for many other validation guidelines and been continuously updated to keep up with the advancement in the field. The U.S. regulation [21 CFR 211.194(a)(2)] recognizes the validation of USP-NF pharmacopeial procedures; however, it also indicates that validated procedures must be verified under actual conditions of use. Guidelines on how to verify pharmacopeial procedures are included in USP General Chapter <1226> Verification of Compendial Procedures. USP information sharing is governed by its document disclosure policy (please see www.usp.org/aboutUSP/governance/policies/overviewStandardsSetting.html), which indicates that USP can make available communications with third parties, such as sponsors, provided that the information is not marked as confidential or does not contain trade secrets.