Auditing | Sponsor | Auditee

IPEA stands firm in its conviction of providing the industry with reliable and accurate audits and reports on excipient GMP manufacturing systems. We recognize that our program stands on the auditors we employ. To assure our customers receive quality audits, IPEA employs expert auditors whom we have trained and qualified in the principles set forth in the IPEC-PQG Guideline.

IPEA auditors are qualified after completing:

• Comprehensive auditor training by a team of seasoned and experienced auditors from excipient and pharmaceutical drug product manufacturers
• Through training in standards from the globally recognized IPEC Current Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients
• On-site simulated audits of actual excipient-producing facilities
• Completion of strenuous assessment exams
  

To preserve the integrity and honestly of our Audit Reports, we require auditors:

• to be honest, impartial, and candid in their approach to ensure objective assessment of the facility being audited.
• to conduct themselves in an objective and professional manner at all times.
• to issue reports that clearly, factually, and accurately describe the operation being audited, and are constructive in nature.
• to not perform or participate in any audit if they have any personal involvement (business connections, financial interests, employment history, or personal or family affiliations) which might influence, or appear to influence, their judgment or jeopardize their objectivity.

We offer a network of auditors who:

• can reach over 110 countries
• are fluent and knowledgeable in local languages and customs
• can perform, on most occasions, audits within 30 days of a request