GCP Compliance in our Vendors

1. GCP Compliance in our Vendors Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008

2. Objectives • Understand how to assess: • GCP Requirements for Clinical Trials • Vendor Compliance

3. GCP • Definition of Good Clinical Practice • A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH E6)

4. GCP

5. Vendors and GCP Vendor Types & General Audit Considerations

6. Vendors and GCP Types of entities to be audited: • CRO’s • Software Suppliers • Specialty Vendors

7. Vendors and GCP Purpose of audit: To ensure that XYZ Company has the appropriate processes, procedures, supporting documentation and qualified personnel to provide quality and compliant services.

8. Vendors and GCP Activities Understanding Documents Interviews Training

9. Vendors and GCP Audit Standards: • 21 CFR Part 11 • FDA Guidance: Computerized Systems Used In Clinical Investigations (05/2007) • <Vendor> Polices, Procedures, and Processes • <Your Company> Policies, Procedures, and Processes

10. Vendors and GCP Common items to audit regardless of type: • Org Chart • Is QA a role within the company? • Is QA independent? • Do they have appropriate management and staff levels to support your business needs?

11. Vendors and GCP Common items to audit regardless of type: • Locations • Where will the work be performed? • Do you need to audit more than one location? • Off-shore component?

12. Vendors and GCP Common items to audit regardless of type: • Documents • Quality Policy/Manual/Procedure • SOP on SOPs • Training Records and Requirements • CVs – current ones outlining their vendor role • Job Descriptions

13. Vendors and GCP Common items to consider regardless of type: • Audit Team • QA Only • QA + Subject Matter Experts (IT, DM, etc…) • How Often • Preferred Provider List • Dictated by company SOP

14. Vendors and GCP Common items to consider regardless of type: • Disaster Recovery/Business Continuity

15. Vendors and GCP Audit Scenarios

16. Vendors and GCP Scenario #1: CRO Audit Items to consider: • What services are being outsourced? • Whose SOPs are being followed? • Trial Master File Considerations?

17. Vendors and GCP Scenario #2: Software Vendor Audit Items to consider: • Hosted or Technology Transfer? • Validation Documentation? • Training on the system for staff/users?

18. Vendors and GCP Scenario #3: Specialty Vendor Audit Items to consider: • What type of role do they have for your company – risk assessment? • Chain of Command • Equipment Use and Maintenance • Computer Platforms – integration of systems

19. Vendors and GCP Performing the Audit

20. Interviews How to assess GCP compliance during an interview?

21. Interviews Describe the process for… Interviews

22. Interviews What regulations apply to your role? Interviews

23. Interviews How are you trained on… ? Interviews

24. Interviews Where is the documentation for … filed? Interviews

25. Personnel Qualifications Trained Personnel Continuing Education Qualified Personnel CV vs. Job Description

26. Report Findings and Observations Compliance with Regulatory Requirements Process and Procedure Qualified and Trained Personnel Good documentation practice If it wasn’t documented, it didn’t happen…

27. Objectives • Understand how to assess: • GCP Requirements for Clinical Trials • Vendor Compliance

28. GCP Compliance in our Vendors Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008