Contract packagers and contract manufacturers have unique challenges when serializing product for the pharmaceutical industry. Michael Stewart, of PharmTech, covers the regulations and project management concerns CMO's and CPO's should address.
4. 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
5. 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)
10. State of the (Pharma) Industry
Serialization Stage*
Evaluating
Strategy/Providers
Small Pilot
Multi Site Roll Out
Not Started
*IQPC “Pharmaceutical Serialisation and
Traceability Survey”, 2012
14. 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
15. 5 Point Solution
A core system that is;
Flexible and scaleable
Standards based
Integration compatible with multiple enterprise
Validation compatibility
Leverages existing infrastructure
16. 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
17. 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
18. How can PharmTech help?
Michael Stewart
mstewart@pharmtechinc.com
(847) 281-8924 Office
(815) 403-8425 Cell