Sponsors | Auditees | Auditors

IPEA provides independent third party audits of excipient manufacturers, following US Pharmacopeia (USP), World Health Organization (WHO), and the IPEC/PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. The program provides cost benefits for both audit sponsors and audited companies.

Audits are performed using IPEA trained and qualified auditors. Our training program begins with the selection of candidate auditors who meet our criteria for education and experience. The candidate auditor must satisfactorily complete our 3-day Excipient GMP Audit Workshop. The candidate auditor then accompanies a qualified auditor in the performance of an audit. Upon the completion of a satisfactory audit report by the candidate, the auditor is then considered qualified and can perform audits for IPEA independently. However, all completed audit reports are reviewed by IPEA Executives to assure they meet our standards. The auditing service is available worldwide employing auditors residing in the geographic locales where the audits are performed.

IPEA's role is to provide assurance that audited excipients meet the necessary specifications and industry standards as defined by information chapter <1078> in the current USP, the IPEC/PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients and WHO.

The audit process begins when IPEA receives a request for an audit on an excipient-manufacturing facility. If an excipient audit report on a facility is available and current, the report is offered for sale. If no report is available, the audit request is processed and the audit requestor becomes the audit sponsor and the excipient-producing facility the auditee.

The sponsor then receives an Audit Application to complete and return.The excipient-producing facility is contacted by an auditor and asked to complete a Pre-audit Questionnaire. The auditor then schedules a visit to the facility to conduct the audit. Normally audits can be completed within 30 days. Every effort is made to meet more urgent needs.

All records and notes are retained by IPEA to insure report and record confidentiality. After two years, audit reports and records are no longer considered representative of current GMP conditions at the excipient manufacturing site and are destroyed. During the two-year period, copies of reports are made available for sale to third parties. More information, regarding availability of reports, can be accessed at the Audit Reports page.

Further information can be found on the Sponsor and Auditee pages.