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Vendor Qualification
Vendor Management
from a CRO QM standpoint
Dr. Ursula Schlichtiger
Zurich May 9, 2012

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Who is a Vendor?
Anybody contracted or
subcontracted to be involved in a
clinical trial
• Company
• Person
• Institution
• Organisation

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Vendors/ Subcontractors
Sponsor
bound per contract
Vendors CRO
bound per contract
Vendors Subcontractors
? 1. Who holds the contract?
2. Which tasks are delegated?

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Regulatory Background Europe (1)
 Commission Directive 2005/28/EC
“GCP Directive”
http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf
 Chapter 2, THE SPONSOR, Article 7
A sponsor may delegate any or all of his trial-related functions to
an individual, a company, an institution or an organization.
However, in such cases, the sponsor shall remain responsible for
ensuring that the conduct of the trials and the final data
generated by those trials comply with Directive 2001/20/EC as
well as this Directive.

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Regulatory Background Europe (2)
 European Commission: Eudralex Volume 10 Chapter IV
Guidance Documents for Inspections:
Annex IV to Guidance for the conduct of GCP Inspections -
Sponsor and CRO“ (28 May 2008):
http://ec.europa.eu/health/files/eudralex/vol10/chap4/annex_iv_to_guidance_for_the_conduct_of_gcp_inspections-
o 2. SPONSOR OR CRO QUALITY SYSTEM INSPECTION
o 3. SPECIFIC CLINICAL TRIAL INSPECTION

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Regulatory Background Europe (cont 2)
2. SPONSOR OR CRO QUALITY SYSTEM INSPECTION:
The aim of this kind of inspection is to evaluate the quality assurance and quality
control systems established by the sponsor/CRO in order to assure that clinical
trials are conducted and data are generated, recorded and reported in
compliance with the protocol, GCP and applicable regulatory requirements.
The following items should be reviewed in a sponsor/CRO system inspection:
2.3.8 Sponsor audit and quality assurance system
The aim is to determine if the sponsor/CRO has established an audit system, as
part of its own quality assurance system, in order to evaluate its activities
related to clinical trials.
It should be determined if the procedures include:
 Audits of key clinical trial processes, including monitoring, data management,
safety reporting, clinical study report production, archiving and computer
system validation activities
 Audits of contractors/subcontractors

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Regulatory Background Europe (cont 2)
The inspectors should also review:
 The processes for communicating and addressing audit findings, including the
format and distribution of audit reports
 The procedures for dealing with serious and/or persistent GCP non-
compliance
 Audit trails
 Procedures for generation and implementation of audit program(s)/plan(s)
2.3.9 Delegation of duties
The aim is to verify the procedures for contracting/subcontracting of trial-related
duties.
Inspectors should examine the procedures related with:
 Pre-selection and ongoing assessment of contractor/subcontractors
 Documentation of duty delegation and its time recording
 Handling contract amendments
 Contracts should be reviewed (either specific ones or a sample)

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Regulatory Background Europe (cont 2)
3. SPECIFIC CLINICAL TRIAL INSPECTION
3.1 Implementation and termination of the clinical trial
The aim is to determine if all legal and administrative aspects of the clinical trial
have been accomplished.
Review:
 Distribution of sponsor’s duties or functions
 ……
3.8 Audit
Determine:
 If the clinical trial was audited and if audit reports exist
 Qualifications of the auditors

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Consequences
 Sponsor and CRO:
• Need a vendor qualification program
» Internal vendors „Affiliates“
» External vendors „Subcontractors“
Risk based approach
SOPs needed

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Risk based Vendor Qualification
1. High risk: Delegation of critical tasks, e.g.
- CROs
- CMOs
- Depots with QP release
Audit mandatory
o Medium risk: Delegation of routine tasks, e.g.
- Courier
- Depots without QP release
- Translation companies
paper based/ audit on case by case basis
o Low risk: e.g.
- provider of commercially available material
paper based
o Freelancers

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CROs/ Subcontractors
 Prequalification (paper based)
• by means of questionnaire and
supporting documents, e.g.
» SOP Index
» QM Manual
» CVs
 Qualification: Audit mandatory

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Depots
with and without QP release

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Courier Services
 Courier Service Companies
• Qualification by means of questionnaire and supporting
documents, e.g.
» ISO certificates, index of quality manual, system description
» Transport validation

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Freelancers
Risk based vs. Realistic approach
paper based: CV
Training records
Personal experience
audit of local situation: security

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Goals?
 All Key Service
Providers should be
qualified.
 Keep a Qualified
Vendor List
 Only Service Providers
from the Qualified
Vendor List should be
chosen
 Train the operational
functions

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Process
 Internal Vendor
Qualification
 Identification of vendors
prior to contracts issued
 Re-Qualification Audits
foreseen every 2 years as per
SOP
includes "experience criteria"
 Qualification after
contracting only in
exceptional cases

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How can Operations help?
 Let QA know which Key
Service
Providers you plan to
work with
 When selecting a vendor
check the Qualified
Vendor List
 Use Vendor Audit
Request Form for new
vendors
 Provide feedback on
experience with vendors

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Request a Vendor Audit!

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Inspection/ Audit Questions
1. Are SOPs available?
2. Do you use vendors?
3. What kind of vendors?
4. Which are internal and which are external vendors?
5. How do you qualify them?
6. How often do you re-qualify them?
7. Which vendors have been qualified?
8. Why do you also allow paper-based qualification?
9. Can we get insight in the audit reports?
10. Does QA have GCP/ GLP and GMP experience?
11. Do you audit against Task Allocation?

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Thank you! Any Questions?
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