School Serialization for Pharma CMO/CPO’s
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How to survive and thrive in the era of serialization
Anything new?
Agenda
Introduction
Today
Challenges
Solutions
Next Steps
PharmTech Inc.
Serving FDA regulated industries since 1995 Involved in Track & Trace since 2005. Working with a Top 10 Pharma Co. and Virtual Manufacturer Industry speaker at conferences, webinars and author of white papers on e-Pedigree/ serialization in pharmaceuticals. Diversified Team Skills; • IT Integration • Quality Management • Distribution • Serialization • Line Integration (Packaging & Manufacturing) • GS1 Standards
PharmTech Project List
• Evaluating solutions providers
• Implementing GS1 Standards
• Piloting for serialized product and trades
• Long-range planning & Impact analysis
• Serialized data share and systems interoperability
• Revising strategy in response to legislation
• Trading partner connection (CMO and CPO to Client)
Today Regulator Perception vs. CMO/CPO Reality
Global Regulations
Perception - Simple
Customer
Order
CMO/CPO
Make/Package
Customer
Receive/Ship
Wholesaler RX
Reality
CMO
CPO
Mfr A Mfr
B
Mfr C
Mfr D
Mfr E
Mfr F
Mfr G
Mnf H
Mfr I
Mfr J
Mfr K
State of the (Pharma) Industry
Serialization Stage*
EvaluatingStrategy/Providers
Small Pilot
Multi Site Roll Out
Not Started
*IQPC “Pharmaceutical Serialisation and Traceability Survey”, 2012
CMO/CPO Challenges
CMO/CPO Challenges
Regulatory timelines
Regulatory uncertainty
Conflicting demands
Lack of visibility
beyond own walls
Evolving standards
Serialization solutions are
system specific
Meeting multiple
customer requirements
Moving Forward “A project well planned is a project already half done well.”
Tackling the Challenges Be proactive
Develop strategy and a LRP
Identify ROI and Business Value, in advance
Define a core solution
Conduct a Gap Analysis
5 Point Solution A core system that is;
Flexible and scaleable
Standards based
Integration compatible with multiple enterprise
Validation compatibility
Leverages existing infrastructure
Why a 5 Point Solution? Business Value;
First mover advantage- let clients connect to you
Scale with company and client growth
Standardization adjusts to new customer and regulatory
mandates
Not if, but when
Reduce integration costs
Next Steps…
• Conduct a Gap Analysis
• Map all relevant processes
• Identify all work areas effected
• Discover efficiencies from automation
• Gather business requirements
• From customers (their needs and requirements)
• Internally
• Conduct an independent vendor assessment
