USP Verified Pharmaceutical Ingredients
USP offers a rigorous third-party verification program to help companies reach best practice quality management for drug substances used in the manufacture of drug products and demonstrate that their ingredients are of consistent high quality. USP experts provide participants with a good manufacturing practice (GMP) audit of manufacturing facilities and operations; a review of drug substance chemistry, manufacturing and controls (CMC) documentation; laboratory testing of drug substances for conformance to specifications; and ongoing change monitoring and surveillance. Learn more.
The USP Verified Mark and What It Means
Ingredients that meet USP’s stringent requirements are awarded a Certificate of Standards Compliance and use of the USP Verified Pharmaceutical Ingredient Mark (above). The Mark can be used on the bulk label of each container of verified ingredients and on the accompanying certificate of analysis. The Mark provides assurance that the ingredient
- is manufactured in accordance with internationally accepted GMPs for pharmaceutical ingredients;
- meets label and certificate of analysis claims for identification, strength, purity, and quality;
- meets acceptable limits for impurities and contaminants; and
- is consistent in quality from batch to batch.
USP Pharmaceutical Ingredient Supplier Qualification Program
USP also offers third-party auditing and testing services to help drug product manufacturers and distributors qualify their suppliers. Once the process is complete, the program participant receives a letter indicating the supplier’s qualification status. Learn more.
Join the Program
USP’s verification and qualification programs are voluntary and are open to interested parties worldwide. To learn more about participation, please contact Dr. John Atwater, Senior Director, USP Verification Programs, at firstname.lastname@example.org or +1-301-816-8529. You can also complete the online application form to submit pharmaceutical ingredients to USP for verification or qualification.