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GCP Compliance in our Vendors. Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008. Objectives. Understand how to assess: GCP Requirements for Clinical Trials Vendor Compliance. GCP. Definition of Good Clinical Practice

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gcp compliance in our vendors

GCP Compliance in our Vendors

Cheryl McCarthy

Manager, Quality Assurance

MBC Session

October 3, 2008

objectives
Objectives
  • Understand how to assess:
    • GCP Requirements for Clinical Trials
    • Vendor Compliance
slide3
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)
vendors and gcp
Vendors and GCP

Vendor Types

&

General Audit Considerations

vendors and gcp6
Vendors and GCP

Types of entities to be audited:

  • CRO’s
  • Software Suppliers
  • Specialty Vendors
vendors and gcp7
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.

vendors and gcp8
Vendors and GCP

Activities

Understanding

Documents

Interviews

Training

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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
vendors and gcp10
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?
vendors and gcp11
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?
vendors and gcp12
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
vendors and gcp13
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
vendors and gcp14
Vendors and GCP

Common items to consider regardless of type:

  • Disaster Recovery/Business Continuity
vendors and gcp15
Vendors and GCP

Audit Scenarios

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Vendors and GCP

Scenario #1: CRO Audit

Items to consider:

  • What services are being outsourced?
  • Whose SOPs are being followed?
  • Trial Master File Considerations?
vendors and gcp17
Vendors and GCP

Scenario #2: Software Vendor Audit

Items to consider:

  • Hosted or Technology Transfer?
  • Validation Documentation?
  • Training on the system for staff/users?
vendors and gcp18
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
vendors and gcp19
Vendors and GCP

Performing the Audit

interviews
Interviews

How to assess GCP compliance during an interview?

interviews21
Interviews

Describe the process for…

Interviews

interviews22
Interviews

What regulations apply to your role?

Interviews

interviews23
Interviews

How are you trained on… ?

Interviews

interviews24
Interviews

Where is the documentation for … filed?

Interviews

personnel qualifications
Personnel Qualifications

Trained Personnel

Continuing Education

Qualified Personnel

CV vs. Job Description

report
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…

objectives27
Objectives
  • Understand how to assess:
    • GCP Requirements for Clinical Trials
    • Vendor Compliance
gcp compliance in our vendors28

GCP Compliance in our Vendors

Cheryl McCarthy

Manager, Quality Assurance

MBC Session

October 3, 2008