webinar hosted by pharmaceutical manufacturing wednesday, november 7 2012 presented by hedley rees,...
TRANSCRIPT
MANAGING CONTRACT PARTNERSHIPSWebinar Hosted by Pharmaceutical Manufacturing
Wednesday, November 7 2012
Presented by Hedley Rees, Biotech PharmaFlow
Agenda
What is behind the ‘supply chain heat’Where do contractors fit in?Management strategies based on
segmentationThe procurement cycleBuilding a foundation for the future
Where is the heat coming from?
Shortages……Economically motivated adulteration……Recalls…..Cost of Goods issues…Counterfeiting…..Theft…..Diversion…..
The fall-out….
Crippling impacts in the areas of patient safety, brand image and reputation, costs of remediation, customer service and investor confidence.
A UNIVERSAL CRY FOR CHANGE!From regulators, governments, other
competent authorities and patient advocacy groups.
5
Stakeholders pile in….
…EU implements Falsified Medicines Directive.
…EMA consults on dramatic tightening of GDP/GMP
…FDA pens “Pathway to Global Safety and Quality”.
…President Obama wades in on drug shortages.
…US HELP Congressional Committee consults.
…US Pharmacopeia consults on new Chapter < 1083 >.
…PEW Charitable Trust writes report “After Heparin”.
…GS1 Global Traceability Standard for Healthcare (GTSH).
…FDA Safety and Innovation Act (FDASIA), Title VII
The Scope of Contractual Relationships•Qualification/validation work for premises• Maintenance /calibration of equipment• Storage and distribution• Artwork generation and print ready material• Assessment and sourcing of starting and packaging materials
•QP and other professional services such as GMP audits of suppliers Washing/depyrogenation/sterilisation of packaging materials used in manufacture.• Hosting of IT functions• Document archiving and storageRef: GMP/GDP INSPECTORS WORKING
GROUP GMP/GDP IWGDocument Ref: EMEA/INS/GMP/648678/2009
Contractor Management in Context
Immensely complex interactions.Relationships are 3rd party.Contractually driven.Power and dependence.Management by Segment.
Procurement Portfolio
Leverage
Strategic
Routine Bottleneck
Portfolio
Many Suppliers Single SupplierComplexity of Supply Market
Financial Relevance
High
Low
Based on Kraljic Matrix, HBR 1983
Procurement Portfolio Management
LeverageExploit
Negotiate hard
Regular tenderin
g
StrategicBuild relationships
Seek innovationJoint investments
RoutineAutomate
StandardiseEmpower users
Bottleneck
Mitigate risk
Change design
Alternate sourcePORTFOLI
O
Many Suppliers Single SupplierComplexity of Supply Market
Financial Relevance
High
Low
Figure 1 A segmentation approach based on Kraljic Matrix
The Procurement Cycle – Strategic Segment
Specify
•User Driven
•Team based
•Request for Proposal
Select
•Involvement of stakeholders
•Decision making process
•Business benefits
Commit
•Agreements – Supply, Quality & Technical, Service level
•Processes for working together
•Information sharing
Perform
•Regular reviews
•Metrics
•Continuous improvement
Building successful contractor partnerships
Robust Supply Base
• cGXP compliant
• Capable processes
• Commercially viable
• Organisationally mature
• Culturally congruent
Inclusive planning process
• Defined envelope of uncertainty
• Adequate capacity
• Appropriate scale
• Thorough risk assessments
• Sourcing and Inventory policy
Sound Agreements
• Procurement cycle
• Supply• QTA• Service level
Process Driven
• End-to-end• Allocation of responsibilities
• Change control
• Metrics