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Pricing
& Discount Policy |
Opt-Out
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How
to Order an Audit
Audit
Application
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" buy the report purchasers.
In
the event an Audit Sponsor does not want the audit report
resold, an Opt-Out option is available.
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
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Available
Discount
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Estimated
base price for
a single excipient audit
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$5,500
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$6,000
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$500*
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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.
*Applicable
when Audit Reports
are sold to interested third parties.
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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 return it 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.
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