06-PQRI Third Party Audit

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Third Party Audit : 

Third Party Audit Advantageous or Risky?

PQRI Survey Results : 

PQRI Survey Results >90% Audit New Suppliers ~85% Certify Vendors ~85% Audit Excipient Suppliers 39% in-house auditors 29% third party 32% questionnaire

PQRI Survey Results : 

PQRI Survey Results Frequency of On-Site Audit to certify excipient suppliers

PQRI Survey Results : 

PQRI Survey Results Excipient Manufacturers Experience: More questionnaires than third party Frequency of hosting audit: weekly 6% Biweekly 29% Monthly 12% Bimonthly 12% Other 41%

Third Party Audit? : 

Third Party Audit? 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: Certification? Audit reports?

Industry Perception : 

Industry Perception How are third party audits viewed? What is the purpose of auditing the supplier? What is the desired outcome? Why not a questionnaire? Do I have to visit them ALL?

Role of Third Party Audit : 

Role of Third Party Audit Is this a requirement for qualifying an: Excipient? Supplier? Can third party be used to develop a good qualification program for excipient suppliers?

Building a Compliant Excipient Audit Program : 

Building a Compliant Excipient Audit Program What qualifications should a third party auditor have? Experience? Training? How can qualified auditors be identified?

Excipient Audit on the Cheap : 

Excipient Audit on the Cheap 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 LineFDA Expectations? : 

Bottom LineFDA Expectations? 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?

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