Transcript Third Party Audit

Third Party Audit
Advantageous or Risky?
PQRI Survey Results
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>90% Audit New Suppliers
~85% Certify Vendors
~85% Audit Excipient Suppliers
• 39% in-house auditors
• 29% third party
• 32% questionnaire
PQRI Survey Results
Frequency of On-Site Audit
to certify excipient suppliers
Annual
Biannual
3-4 Years
>4 Years
5%
43%
39%
13%
PQRI Survey Results
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Excipient Manufacturers Experience:
• More questionnaires than third party
• Frequency of hosting audit:
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weekly
Biweekly
Monthly
Bimonthly
Other
6%
29%
12%
12%
41%
Third Party Audit?
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What is a third party audit?
• Audit by independent contractor hired to
perform audit?
• Audit by firm hired to perform audit?
• Audit by organization that offers:
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Certification?
Audit reports?
Industry Perception
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How are third party audits viewed?
What is the purpose of auditing the
supplier?
• What is the desired outcome?
• Why not a questionnaire?
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Do I have to visit them ALL?
Role of Third Party Audit
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Is this a requirement for qualifying
an:
• Excipient?
• Supplier?
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Can third party be used to develop a
good qualification program for
excipient suppliers?
Building a Compliant Excipient
Audit Program
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What qualifications should a third
party auditor have?
• Experience?
• Training?
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How can qualified auditors be
identified?
Excipient Audit on the Cheap
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Do small manufacturers have to
audit excipient suppliers?
How would small manufacturers
benefit from a third party audit?
What alternatives are there to site
visits?
• What are the advantages and
disadvantages of questionnaires?
• Can we rely on regulatory visits?
Bottom Line
FDA Expectations?
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What degree of control of excipient
suppliers by drug producers does
FDA expect?
Must all suppliers be audited?
• Are second party audits the only
acceptable means?
• What is the expectation if third party
audits are used?