Mmc vendor qualification and management -dr. ursula schlictiger-may2012

FOCUSED. TRUSTED. GLOBAL.

Vendor Qualification Vendor Management

from a CRO QM standpointDr. Ursula Schlichtiger

Zurich May 9, 2012



Anybody contracted or subcontracted to be involved in a clinical trial

• Company• Person• Institution• Organisation

Who is a Vendor?


Vendors/ Subcontractors

Sponsor

Vendors CRO

Vendors Subcontractors

bound per contract

bound per contract

? 1. Who holds the contract?2. Which tasks are delegated?


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 7A 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.


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-sponsor_and_cro_en.pdf

o 2. SPONSOR OR CRO QUALITY SYSTEM INSPECTIONo 3. SPECIFIC CLINICAL TRIAL INSPECTION


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 systemThe 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


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 dutiesThe 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)


Regulatory Background Europe (cont 2)3. SPECIFIC CLINICAL TRIAL INSPECTION

3.1 Implementation and termination of the clinical trialThe 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


Consequences

Sponsor and CRO: • Need a vendor qualification program

»Internal vendors „Affiliates“»External vendors „Subcontractors“

Risk based approachSOPs needed


Risk based Vendor Qualification

1. High risk: Delegation of critical tasks, e.g.- CROs- CMOs

- Depots with QP releaseAudit mandatory

2. Medium risk: Delegation of routine tasks, e.g.- Courier- Depots without QP release- Translation companiespaper based/ audit on case by case basis

3. Low risk: e.g.- provider of commercially available materialpaper based

4. Freelancers


CROs/ Subcontractors

Prequalification (paper based)• by means of questionnaire and supporting documents, e.g.

» SOP Index» QM Manual» CVs

Qualification: Audit mandatory


Depots with and without QP release


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


Freelancers

Risk based vs. Realistic approach

paper based: CVTraining recordsPersonal experience

audit of local situation: security


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

Goals?


Internal Vendor Qualification

Identification of vendors prior to contracts issued

Re-Qualification Auditsforeseen every 2 years as per SOPincludes "experience criteria"

Qualification after contracting only in exceptional cases

Process


Let QA know which Key ServiceProviders you plan to work with

When selecting a vendorcheck the Qualified Vendor List

Use Vendor Audit Request Form for new vendors

Provide feedback on experience with vendors

How can Operations help?


Request a Vendor Audit!


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?


o Medpace Medical Consulting GmbHNussbaumstr. 1080336 MunichGermanyTel: +49 (0) 89 673 79 16Fax: +49 (0) 89 670 21 00E-mail: [email protected]

Thank you! Any Questions?

Business

Mmc vendor qualification and management -dr. ursula schlictiger-may2012