Third Party AuditThird Party Audit

Advantageous or Risky?Advantageous or Risky?

PQRI Survey ResultsPQRI Survey Results

>90% Audit New Suppliers>90% Audit New Suppliers ~85% Certify Vendors~85% Certify Vendors ~85% Audit Excipient Suppliers~85% Audit Excipient Suppliers

• 39% in-house auditors39% in-house auditors• 29% third party29% third party• 32% questionnaire32% questionnaire

PQRI Survey ResultsPQRI Survey Results

AnnualAnnual BiannualBiannual 3-4 Years3-4 Years >4 Years>4 Years

5%5% 43%43% 39%39% 13%13%

Frequency of On-Site Audit to certify excipient suppliers

PQRI Survey ResultsPQRI Survey Results

Excipient Manufacturers Experience:Excipient Manufacturers Experience:• More questionnaires than third partyMore questionnaires than third party• Frequency of hosting audit:Frequency of hosting audit:

weeklyweekly 6% 6% BiweeklyBiweekly 29%29% MonthlyMonthly 12%12% BimonthlyBimonthly 12%12% OtherOther 41%41%

Third Party Audit?Third Party Audit?

What is a third party audit?What is a third party audit?• Audit by independent contractor hired to Audit by independent contractor hired to

perform audit?perform audit?• Audit by firm hired to perform audit?Audit by firm hired to perform audit?• Audit by organization that offers:Audit by organization that offers:

Certification?Certification? Audit reports?Audit reports?

Industry PerceptionIndustry Perception

How are third party audits viewed?How are third party audits viewed? What is the purpose of auditing the What is the purpose of auditing the

supplier?supplier?• What is the desired outcome?What is the desired outcome?• Why not a questionnaire?Why not a questionnaire?

Do I have to visit them ALL?Do I have to visit them ALL?

Role of Third Party AuditRole of Third Party Audit

Is this a requirement for qualifying Is this a requirement for qualifying an:an:• Excipient?Excipient?• Supplier?Supplier?

Can third party be used to develop a Can third party be used to develop a good qualification program for good qualification program for excipient suppliers?excipient suppliers?

Building a Compliant Excipient Building a Compliant Excipient Audit ProgramAudit Program

What qualifications should a third What qualifications should a third party auditor have?party auditor have?• Experience?Experience?• Training?Training?

How can qualified auditors be How can qualified auditors be identified?identified?

Excipient Audit on the CheapExcipient Audit on the Cheap

Do small manufacturers have to Do small manufacturers have to audit excipient suppliers?audit excipient suppliers?

How would small manufacturers How would small manufacturers benefit from a third party audit?benefit from a third party audit?

What alternatives are there to site What alternatives are there to site visits?visits?• What are the advantages and What are the advantages and

disadvantages of questionnaires?disadvantages of questionnaires?• Can we rely on regulatory visits?Can we rely on regulatory visits?

Bottom LineBottom LineFDA Expectations?FDA Expectations?

What degree of control of excipient What degree of control of excipient suppliers by drug producers does suppliers by drug producers does FDA expect?FDA expect?

Must all suppliers be audited?Must all suppliers be audited?• Are second party audits the only Are second party audits the only

acceptable means?acceptable means?• What is the expectation if third party What is the expectation if third party

audits are used?audits are used?