Sponsors
Pricing & Discount Policy
IPEA's Auditing Program offers a unique cost-sharing service which provides high quality excipient GMP auditing without the usually prohibitive high costs.
In this program, an audit's total cost "decreases" overtime through an innovative discount and credit policy. Participating Sponsors receive a $500 credit towards the purchase of an existing report, or towards sponsorship of a future audit, each time a third party purchases a report they sponsored.
Through repeated report sales, a Sponsor's audit costs are recovered and, consequently, are "shared" by the report purchasers.
In the event an Audit Sponsor does not want the audit report resold, an Opt-Out option is available (see Form 09 below). Although the audit cost will be higher, the fees will nevertheless still be cost-effective and competitive.
Pricing & Discount Policy
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IPEC-Americas Members
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Non-Members
|
Available Discount
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|
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Estimated base price for
a single excipient audit |
$6,000
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$6,500
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$500
|
Final price is determined by the nature and scope of an audit. Audits of more than one excipient produced at the same site can be arranged with only additional charges for time and expenses. Audits with extraordinary travel requirements and related costs may cost slightly higher.
Discount applicable when Audit Reports are sold to interested third parties.
Opt-Out
Sponsors who elect to Opt-Out will have the resulting audit report withheld from sale. An additional $2,000 will be assessed to cover IPEA's operational costs.
How to Order an Audit
To initiate an audit of an excipient-producing facility, it is necessary to complete an Audit Application and Form 09-Audit Report Authorization form and return them to IPEA. When received, the audit request is reviewed and an Auditor is assigned. The auditor contacts the excipient manufacturer to arrange a site visit. The scheduled audit date is cleared with Sponsor before it is finalized.
Once the audit is completed, the draft report is reviewed by IPEA to confirm the draft report meets all IPEA standards before it is forwarded to the excipient manufacturer for their review.
The excipient manufacturer has 10 business days to review the report and request correction of any factual errors, removal of confidential information and to provide a corrective action where warranted. If necessary, the manufacturer can request additional time.
Audit reports are sent via overnight express mail to the Sponsor. Normally, audits can be completed within 30 calendar days.
| Audit Quick Links |
| Audit Application Form |
| Form 09-Audit Report Authorization |
| Pre Audit Questionnaire Form |
