IPEA provides independent third party audits of excipient manufacturers, following US Pharmacopeia (USP), General Information Chapter <1078>, and the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. The program provides cost benefits for both excipient makers and pharmaceutical users.
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 or an approved equivalent. Auditors with suitable excipient audit experience can apply to attend a 1-day Excipient GMP Expectations course as an alternative. The candidate auditor then accompanies a qualified auditor in the performance of an audit. Upon the completion of a satisfactory audit and appropriate 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 provides assurance that audited excipient manufacturing sites meet industry standards as defined by General Information Chapter <1078> in the current USP, and the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients.
The audit process begins when IPEA receives a request for an audit of an excipient-manufacturing facility. If an excipient audit report of 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 facility is contacted and asked to complete a Pre-audit Questionnaire. IPEA assigns an auditor who then schedules a visit to the facility to conduct the audit and prepares an audit plan. Normally audits can be completed within 30 days. Every effort is made to meet more urgent needs.
IPEA maintains 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.
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Contact the IPEA office with any questions: 703-351-5266