1. Third Party Audit Advantageous or Risky?

2. PQRI 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

3. PQRI Survey Results AnnualBiannual 3-4 Years >4 Years 5%43%39%13% Frequency of On-Site Audit to certify excipient suppliers

4. PQRI 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: weekly 6% weekly 6% Biweekly29% Biweekly29% Monthly12% Monthly12% Bimonthly12% Bimonthly12% Other41% Other41%

5. Third Party Audit? What is a third party audit? What is a third party audit? Audit by independent contractor hired to perform audit?Audit by independent contractor hired to 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?

6. Industry Perception How are third party audits viewed? How are third party audits viewed? What is the purpose of auditing the supplier? What is the purpose of auditing the 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?

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

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

9. Excipient Audit on the Cheap Do small manufacturers have to audit excipient suppliers? Do small manufacturers have to audit excipient suppliers? How would small manufacturers benefit from a third party audit? How would small manufacturers benefit from a third party audit? What alternatives are there to site visits? What alternatives are there to site visits? What are the advantages and disadvantages of questionnaires?What are the advantages and disadvantages of questionnaires? Can we rely on regulatory visits?Can we rely on regulatory visits?

10. Bottom Line FDA Expectations? What degree of control of excipient suppliers by drug producers does FDA expect? What degree of control of excipient suppliers by drug producers does FDA expect? Must all suppliers be audited? Must all suppliers be audited? Are second party audits the only acceptable means?Are second party audits the only acceptable means? What is the expectation if third party audits are used?What is the expectation if third party audits are used?