USP Verified Pharmaceutical Ingredients
In response to increasing concerns about quality and consistency of pharmaceutical ingredients, USP offers a rigorous verification program for Active Pharmaceutical Ingredients (APIs) 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.
USP Pharmaceutical Ingredient Verification helps companies reach best practice quality systems management. USP experts provide drug substance manufacturers with Good Manufacturing Practices (GMP) auditing, ingredient chemistry, manufacturing and controls (cmc), document review, ingredient laboratory testing, and ongoing change reporting and surveillance.
The USP Verified Mark and What It Means
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 quality, purity and potency. The mark can be used on each container of verified ingredients, as well as on 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 GMPs for APIs and excipients; and
- meet requirements for acceptable limits of contamination.
Join the Program
Any drug substance or excipient manufacturer that would like to voluntarily demonstrate product quality can participate. Interested parties should contact V. Srini Srinivasan, Ph.D., Executive Vice President, Global Science and Standards & Chief Science Officer, at email@example.com or +1-301-816-8334.