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

Cheryl McCarthyManager, Quality Assurance

MBC SessionOctober 3, 2008

GCP Compliance in our Vendors

2CMcCarthy – MBC 2008

Objectives

Understand how to assess:

GCP Requirements for Clinical Trials

Vendor Compliance


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)


GCP


Vendors and GCP

Vendor Types&

General Audit Considerations


Vendors and GCP

Types of entities to be audited:

CRO’s

Software Suppliers

Specialty Vendors


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 GCP

Activities

Understanding

Documents

Interviews

Training


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 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 GCP


Locations

Where will the work be performed?

Do you need to audit more than one location?

Off-shore component?


Vendors and GCP


Documents

Quality Policy/Manual/Procedure

SOP on SOPs

Training Records and Requirements

CVs – current ones outlining their vendor role

Job Descriptions


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 GCP

Common items to consider regardless of type:

Disaster Recovery/Business Continuity


Vendors and GCP

Audit Scenarios


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 GCP

Scenario #2: Software Vendor Audit

Items to consider:

Hosted or Technology Transfer?

Validation Documentation?

Training on the system for staff/users?


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 GCP

Performing the Audit


Interviews

How to assess GCP compliance during an interview?


Interviews

Interviews

Describe the process for…


Interviews

Interviews

What regulations apply to your role?


Interviews

Interviews

How are you trained on… ?


Interviews

Interviews

Where is the documentation for … filed?


Personnel Qualifications

Qualified PersonnelCV vs. Job Description

Trained Personnel

Continuing Education


Report

Findings and Observations

If it wasn’t documented, it didn’t happen…

Compliance withRegulatory

RequirementsProcess and Procedure

Qualified and Trained

Personnel

Good documentation practice


Objectives

Understand how to assess:

GCP Requirements for Clinical Trials

Vendor Compliance

Cheryl McCarthyManager, Quality Assurance

MBC SessionOctober 3, 2008

GCP Compliance in our Vendors