USP Pharmaceutical Product Quality Testing Program

The USP Pharmaceutical Product Quality Testing program is a voluntary testing option for generic drug manufacturers to showcase their commitment to and investment in the quality of their medicines.

The program will test products from the commercial supply chain using only scientifically validated quality testing methods – either found in USP’s public quality standards published in the United States Pharmacopeia – National Formulary (USP-NF) or those accepted by the U.S. Food and Drug Administration (FDA).

USP will share passing testing results with organizations that purchase generic medicines to inform purchasing and procurement decisions.

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Unvalidated methods for medicine quality testing can yield misleading results

The use of unvalidated methods can lead to incorrect results, misinformation about medicine quality and a range of other harmful consequences.

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USP’s Pharmaceutical Product Quality Testing Program pilot report

Key lessons from USP’s PPQT pilot program include the importance of using validated, fit-for-purpose methods; tailoring test protocols to each product; and ensuring deep regulatory and compendial knowledge.

Questions about USP’s Pharmaceutical Product Testing Program?

Email TestingProgram@usp.org to learn more about the program and how to participate.