Third Party Audit

1
Third Party Audit

• Advantageous or Risky?

2
PQRI Survey Results

• gt90 Audit New Suppliers
• 85 Certify Vendors
• 85 Audit Excipient Suppliers
• 39 in-house auditors
• 29 third party
• 32 questionnaire

3
PQRI Survey Results
Frequency of On-Site Audit to certify excipient
suppliers
Annual Biannual 3-4 Years gt4 Years
5 43 39 13
4
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

5
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?

6
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?

7
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?

8
Building a Compliant Excipient Audit Program

• What qualifications should a third party auditor
  have?
• Experience?
• Training?
• How can qualified auditors be identified?

9
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?

10
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?