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USP Verified Pharmaceutical Ingredients

Overview

In response to increasing concerns about quality and consistency of pharmaceutical ingredients, USP offers a rigorous verification program for API's and excipients. This service assures manufacturers, regulatory authorities, and consumers that drug substances and excipients bearing the distinctive USP Verified Mark are of consistent, high quality.

What is USP Pharmaceutical Ingredient Verification?

The USP Verified Pharmaceutical Ingredient Mark
The USP Verified Pharmaceutical
Ingredient Mark

USP Pharmaceutical Ingredient Verification helps companies reach best practice quality management. USP experts provide drug substance manufacturers with Good Manufacturing Practices (GMP) auditing, document review, laboratory testing, and ongoing change reporting and surveillance.

What Does the USP Verified Mark Stand For?

USP awards use of the USP Verified Mark to companies and pharmaceutical ingredients that pass all USP verification requirements: GMP audit, thorough documentation review, and testing for purity and potency. The mark can be used on each container of verified ingredients, as well as an accompanying Certificate of Analysis, demonstrating the quality and integrity of the product. USP Verified pharmaceutical ingredients are also issued a USP Certificate of Standards Compliance–currently the highest quality and most comprehensive verification on the market.

Pharmaceutical product manufacturers who buy ingredients verified by USP have the assurance that the ingredients

  • are consistent in quality from batch to batch;
  • meet label or certificate of analysis claims for identification, strength, purity, and quality;
  • are manufactured in accordance with the internationally accepted Good Manufacturing Practices for Drug Substances and Excipients; and
  • meet requirements for acceptable limits of contamination.

What is the Process?

The verification program has four elements that are delivered in the first year and then differentially in intervening years for each ingredient:

  1. Evaluation and review of manufacturing and quality control documentation
  2. GMP audit within a window supplied by the manufacturer
  3. Comprehensive laboratory testing
  4. Surveillance and post-certification, includes continued monitoring and change reporting

To maintain integrity of the USP Certificate of Standards Compliance, the following components are delivered in each intervening year:

  1. Evaluation and review of documents via an Annual Report that is delivered by the company
  2. Audit — in the intervening years, self audits are conducted that will focus on previous areas of risk. USP may conduct additional audits in its sole discretion
  3. Laboratory testing on selected lots

The USP Pharmaceutical Ingredient Verification Manual for Participants contains all the details and specifications for the program. USP invites you to download a PDF version of the manual for Drug Substances   (577KB) and for Excipients  (651KB) or you may request a print copy by sending your name and address via email to .

How Can You Participate?

Any drug substance or excipients manufacturer that would like to voluntarily demonstrate product quality can participate. Interested parties should contact V. Srini Srinivasan, Ph.D., Vice President, USP Verification Programs, at or 301-816-8334.

Participant and Education Resources

Click on the following link for the application to submit products to the USP Verification Program for dietary ingredients.