IPEA stands firm in its conviction of providing the industry with reliable and accurate audits and reports of 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.
Reliable Auditors = Reliable Audits
IPEA auditors are qualified after completing:
- Comprehensive auditor training by experienced auditors with excipient and pharmaceutical drug product manufacture expertise.
- Thorough training in standards from the globally recognized Joint IPEC-PQG Good Manufacturing Practices Guide and Audit Guide for Pharmaceutical Excipients
- On-site audits of actual excipient-producing facilities or simulated classroom audit exercise
- Completion of an observed audit including report
To preserve the integrity and honesty 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.
- Conduct themselves in an objective and professional manner at all times.
- Issue reports that clearly, factually, and accurately describe the operation being audited, and are constructive in nature.
- 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.