Auditing Process

The IPEA audit process begins with receipt of an Audit Application from the company sponsoring the audit. Once the audit application has been processed, a certified auditor contacts the facility to be audited and sends a Pre-audit Questionnaire. The completed questionnaire is used by the auditor to develop an audit plan in advance and helps reduce the amount of time needed to be on site. Thereafter, an audit date is established with the facility and the audit plan is shared so that certain records can be made available for review during the audit.

On the day of the audit, the auditor has a preliminary meeting with facility representatives to finalize the audit plan. Most audits can be completed in a one eight-hour day. Audits of multiple excipients produced at the same site may require an additional day but usually not more than that.

Upon audit completion, a short meeting is held to provide a general review of audit findings. Within ten business days a draft report undergoes a quality review by IPEA and is forwarded to the audited facility. The audited facility then has ten additional business days to review the draft report for factual errors and confidential information and also to provide details of any corrective action to be taken. If additional time is needed, an extension can be requested. Corrective and preventive action plans provided by the audited site are included as an addendum to the final report. A final report is sent to the audit sponsor within ten additional business days

All records and notes are retained by IPEA to assure 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.

During the two-year period, copies of reports are considered current and can be made available, to third parties through the Audit Report program. The audited manufacturing company is given the opportunity to intercede to prevent the sale of an audit report to a competitor.

The Audit Report program provides audited companies with the opportunity to utilize reports as a testament of GMP compliance to potential customers. Auditees are offered special pricing plans on bulk report orders.