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.
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