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A Risk-basedApproach to SupplierSelection
Dr Siegfried SchmittPrincipal Consultant
PAREXEL
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Agenda Suppliers - selection criteria
Selecting suppliers - how?
Managing Risks - ICH Q9
The Competence Maturity Model How (not) to do it
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Selection Criteria
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Supplier Ratings
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Real Life Facts Not every supplier will also become a partner
Time pressures could lead to wrong and costlydecisions
Limited resources for assessing suppliers
www.contractpharma.com
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RequirementsIt all starts with well defined Business
Requirements (your shopping list): Clear
Unambiguous
Verifiable Prioritised if possible (Must have, Nice to have)
At an appropriate level of detail (too vague and
anything will do, too detailed and you will spendyears looking and nothing will fit - the hardestpart)
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Understand & Manage Risks
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ICH Q9
www.ich.org
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Risk Management
Audits?
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Example: Outsourcing
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Matching Capabilities
www.pda.org/bookstore
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How not to select a CMOWhat the company needed
Supply of material for Clinical Trial Phases I and II forUSA and EU
Development of lyophilisation process (no in-houseexpertise)
All process and analytical validation data for thesubmissions
What the company did
Selected supplier based on friendly
recommendation Outsourced all activities, including project
management to the CMO
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How not to select a CMOWhat the supplier delivered
One formulation, one batch of product
Batch Record Documentation
What the supplier didnt deliver
Rationale for selected formulation or any
development documentation Rationale for extreme lyophilisation cycle
Analytical validation protocols or data
Supplier had passed many FDA inspections andhad to shut down following an EMEA inspection
CMO became unresponsive
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How not to select a CMOWhat the company should have done
Seek the help of experts in the field (e.g. consultancy) Understand and document all expectations and
requirements
Perform a Supplier Audit
Enter into a contract that details all the deliverablesby milestones and link payments to these
Have an alternative supplier evaluated
Retain certain project management activities in-house
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When to trust and when to auditWhat the company needed
Supplier and host for a pharmacovigilance system Computerised system validation support
What the company did
Selected supplier based on price and referencescited by supplier
What the company did not ask for
A service level agreement (SLA)
Computer System Validation (CSV)Documentation
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When to trust and when to auditWhat the supplier delivered
Hosting of its proprietary pharmacovigilance system Help desk support
What happened next
An EMEA pharmacovigilance inspection of thecompany identified lack of CSV evidence:
The company had no documentation concerning the validationof the XYZ system (e.g. traceability matrices, validation
summary report or user acceptance tests). The companytherefore had no assurance the system had been adequatelyvalidated.
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When to trust and when to auditWhat the company should have done
Understand and document all expectationsand requirements
Perform a Supplier Audit (especially with a
hosting company) Have an acceptable Service Level Agreement
in place and test it
Seek the help of experts in the field (e.g.consultancy)
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Avoid Prejudice - Establish FactsWhat the company needed
CMO for an API (chemical synthesis) Material for Clinical Trials in USA, Europe and Asia
What the company did
Selected a Chinese supplier based onrecommendations and price
Performed a supplier audit
Hired subject matter expert for the audit
Supplied translators during the audit
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Avoid Prejudice - Establish FactsWhat the audit revealed
Supplier has a Quality Management System in placethat meets US and EU regulatory expectations
Personnel has excellent understanding of GMP andthe right mindset
Adequate facilities and operations
Impressive analytical setup
Almost flawless documentation
Validation documentation is part of the package
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Worth the risk? Impact to business operations and
strategy Impact to product and patient
Impact to regulatory and qualitycompliance
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