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.

1. SchoolSerialization for Pharma CMO/CPO’s
Back to
How to survive and thrive in the era of serialization

2. Anything new?

3. Agenda
 Introduction
 Today
 Challenges
 Solutions
 Next Steps

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)

6. Today
Regulator Perception vs. CMO/CPO Reality

7. Global Regulations

8. Perception - Simple
Customer
Order
CMO/CPO
Make/Package
Customer
Receive/Ship
Wholesaler
RX

9. 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

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

11. CMO/CPO
Challenges

12. 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

13. Moving Forward
“A project well planned is a project already half done well.”

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