The USP Pharmaceutical Ingredient Verification & Qualification Processes

Processes related to verification and qualification vary according to type of substance submitted to USP and services provided. Click on the program name to learn details about each service.

Drug Substance Verification

  • Evaluation of participants' quality systems through an audit of each manufacturing site for compliance with Good Manufacturing Practices (e.g., ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients )
  • Review of manufacturing and quality control documents for each drug substance submitted for verification, including review of characterization, stability, and release data for compliance with labeling and certificate of analysis claims as well as compliance with USP–NF monographs as applicable.
  • Laboratory testing of drug substance samples from selected lots for compliance with labeling or certificate of analysis claims and program requirements.
  • Post-verification surveillance testing, audits, and changes notification activities are conducted to ensure that the drug substance continues to meet program requirements.

For complete details, see the USP Verified Pharmaceutical Ingredients Participants Manual

Excipient Verification

  • Evaluation of participants' quality systems through an audit of each manufacturing site for compliance with Good Manufacturing Practices (i.e., USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients; the Joint International Pharmaceutical Excipients Council and Pharmaceutical Quality Group (IPEC-PQG) Good Manufacturing Practices Guide for Pharmaceutical Excipients, and the World Health Organization (WHO)Technical Report Series, No. 885, 1999, Annex 5: Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients)
  • Review of chemistry, manufacturing, and controls documentation for targeted excipients submitted for verification, including review of characterization, stability, and/or release data for compliance with labeling and certificate of analysis claims as well as compliance with USP–NF, European Pharmacopoeia, British Pharmacopoeia, Japanese Pharmacopoeia monographs, as applicable
  • Laboratory testing of targeted excipient samples from selected lots for compliance with labeling or certificate of analysis claims and Program requirements
  • Post-verification surveillance testing, audits, and change notification activities are conducted to ensure that the excipient continues to meet program requirements

For complete details, see the USP Verified Excipients Participants Manual

Drug Substance Supplier Qualification

The Drug Substance Supplier Qualification Program involves Good Manufacturing Practices (GMP) auditing and testing for conformity for drug substances used in the manufacture of pharmaceutical products. Steps in the process include

  • Evaluation of suppliers' quality systems through audit of each manufacturing site for compliance with Good Manufacturing Practices {C}
  • Testing for compliance with USP–NF, EP and/or JP monographs, as applicable. In addition, testing for the drug product manufacturer's additional specifications, if any.
  • Laboratory testing of drug substance samples from selected batches for compliance with the supplier's specification for the drug substance.
  • Issuance of a letter to the participant, indicating the supplier's USP Drug Substance SQP qualification status.

For complete details, see the USP Drug Substances Qualification Participants Manual

Excipient Supplier Qualification

The Excipient Supplier Qualification Program involves Good Manufacturing Practices (GMP) auditing and testing for conformity for excipients used in the manufacture of pharmaceutical products. Steps in the process include

  • Evaluation of suppliers' quality systems through an audit of each manufacturing site for compliance with Good Manufacturing Practices (i.e., USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients; the Joint International Pharmaceutical Excipients Council and Pharmaceutical Quality Group (IPEC-PQG) Good Manufacturing Practices Guide for Pharmaceutical Excipients, and the World Health Organization (WHO)Technical Report Series, No. 885, 1999, Annex 5: Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients)
  • Testing for compliance with USP–NF, EP and/or JP monographs, as applicable. In addition, testing for the drug product manufacturer's additional specifications, if any.
  • Laboratory testing of drug substance samples from selected batches for compliance with the supplier's specification for the drug substance.
  • Issuance of a letter to the participant, indicating the supplier's USP Drug Substance SQP qualification status.

For complete details, see the USP Excipients Supplier Qualification Participants Manual