Increased Use of Third Party Audits

1. Increased Use of Third Party Audits For Improved Control Topic C Closing Presentation

2. Excipient Manufacturers Reduced site audits Reduced questionnaires 2nd party auditors not always familiar with excipients 3rd party more consistent between auditors Do excipient manufacturers prepare more for 3rd party audit? Negative first impression Acceptance of 3rd Party Audit

3. Pharmaceutical Manufacturers Quality 3rd Party Audit program Excipient manufacturer specific Previously audited Good Receiving and Production History Issues with supplier not passed to audit group No regulatory issues to discuss-e.g. Residual Solvents Acceptance of 3rd Party Audit

4. Pharmaceutical Manufacturers Audits of more excipient manufacturers 3rd Party auditor allowed more time on-site=more thorough assessment Avoid risk management for deciding who to audit FDA Position Acceptable with proper controls Acceptance of 3rd Party Audit

5. Types of audits: Initial Qualification-2nd or 3rd party For Cause-probably 2nd party Surveillance-preferably 3rd party Response to Regulatory Action-2nd Party Non-manufacturing scope-3rd Party Consumers benefit from assurance of excipient conformance Acceptance of 3rd Party Audit

6. 3rd Parties already being used for: Packaging Testing Manufacturing Obstacle: Supplier Audit SOPs often preclude 3rd Party Audit Security Acceptance of 3rd Party Audit

7. 3rd party audit must be equivalent to 2nd Party 3rd party audit adds new perspective How do you handle serious adverse findings? Who is notified of findings? 3rd Party Audit and Supplier Qualification

8. Pharmaceutical firm must be able to action the report Excipient Audit of manufacturers with low volumes ISO 9001 certified program 3rd Party Audit and Supplier Qualification

9. SOPs describing program operation Pre-Audit Questionnaire Established Audit Standard Report Content Confidentiality of audits Independent and unbiased organization and auditors Qualification and reputation of the organization and auditors Expectations of a 3rd Party Audit Program

10. Qualify 3rd Party Audit Program by comparing reports for same excipient Firm doing 3rd Party Audit should not consult Mock or sample audit report Mechanism to confirm the veracity of the findings Excipient manufacturer audit report review Expectations of a 3rd Party Audit Program

11. Training General Audit ASQ Certified Quality Auditor ISO 9001 Certified Lead Auditor Recognized Auditor Training Course Excipient GMPs Experience Appropriate background including API Understanding of regulated environment Qualifications of the 3rd Party Auditor

12. Knowledgeable on difference between 21 CFR Part 211 and USP General Information Chapter <1078> Prioritize/categorize audit observations Know what is important to audit Know what findings are important Demonstrate audit competency Qualifications of the 3rd Party Auditor

13. Pharmaceutical Manufacturers Audit has more credibility than questionnaire How do you know answers are truthful? Small customers cannot audit excipient manufacturer Avoid staff of auditors Reduced number of audits especially outside the US. Allows generics to assess more excipient producers Benefits to Small Manufacturers

14. Excipient manufacturers Audit helps assure their conformance Benefits to Small Manufacturers

15. Web sites: Third Party Audits WWW.IPEAINC.com WWW.USP.org Closing Comments / Questions