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Auditing
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Sponsor
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IPEA
stands firm in its conviction of providing the
industry with reliable and accurate audits and
reports of excipient GMP manufacturing systems.
We recognize that our program stands on the auditors
we employ. To assure our customers receive quality
audits, IPEA employs expert auditors whom we have
trained and qualified in the principles set forth
in the IPEC-PQG Guideline.
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Reliable
Auditors = Reliable Audits
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IPEA
auditors are qualified after completing:
- Comprehensive
auditor training by experienced
auditors with excipient and pharmaceutical drug
product manufacture expertise.
- Thorough
training in standards from the globally recognized
Joint IPEC-PQG Good Manufacturing Practices Guide
and Audit Guide for Pharmaceutical Excipients
- On-site audits of actual excipient-producing
facilities or simulated classroom audit exercise
- Completion
of an observed audit including report
To
preserve the integrity and honesty of our Audit
Reports, we require auditors to:
- Be honest,
impartial, and candid in their approach to ensure
objective assessment of the facility being audited.
- Conduct
themselves in an objective and professional
manner at all times.
- Issue reports
that clearly, factually, and accurately describe
the operation being audited, and are constructive
in nature.
- Not perform
or participate in any audit if they have any
personal involvement (business connections,
financial interests, employment history, or
personal or family affiliations) which might
influence, or appear to influence, their judgment
or jeopardize their objectivity.
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