SchoolSerialization for Pharma CMO/CPO’sBack toHow 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 1995Involved in Track & Trace since 2005.Working with a Top 10 Pharma...
PharmTech Project List• Evaluating solutions providers• Implementing GS1 Standards• Piloting for serialized product and tr...
TodayRegulator Perception vs. CMO/CPO Reality
Global Regulations
Perception - SimpleCustomerOrderCMO/CPOMake/PackageCustomerReceive/ShipWholesalerRX
RealityCMOCPOMfrA MfrBMfrCMfrDMfrEMfrFMfrGMnfHMfr IMfr JMfrK
State of the (Pharma) IndustrySerialization Stage*EvaluatingStrategy/ProvidersSmall PilotMulti Site Roll OutNot Started*IQ...
CMO/CPOChallenges
CMO/CPO Challenges Regulatory timelines Regulatory uncertainty Conflicting demands Lack of visibilitybeyond own walls...
Moving Forward“A project well planned is a project already half done well.”
Tackling the ChallengesBe proactiveDevelop strategy and a LRPIdentify ROI and Business Value, in advanceDefine a core solu...
5 Point SolutionA core system that is; Flexible and scaleable Standards based Integration compatible with multiple ente...
Why a 5 Point Solution?Business Value; First mover advantage- let clients connect to you Scale with company and client g...
Next Steps…• Conduct a Gap Analysis• Map all relevant processes• Identify all work areas effected• Discover efficiencies f...
How can PharmTech help?Michael Stewartmstewart@pharmtechinc.com(847) 281-8924 Office(815) 403-8425 Cell
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Cpo cmo serialization back to school

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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.

Published in: Health & Medicine
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Cpo cmo serialization back to school

  1. 1. SchoolSerialization for Pharma CMO/CPO’sBack toHow to survive and thrive in the era of serialization
  2. 2. Anything new?
  3. 3. Agenda Introduction Today Challenges Solutions Next Steps
  4. 4. PharmTech Inc.Serving FDA regulated industries since 1995Involved in Track & Trace since 2005.Working with a Top 10 Pharma Co. and Virtual ManufacturerIndustry speaker at conferences, webinars and author ofwhite papers on e-Pedigree/ serializationin pharmaceuticals.Diversified Team Skills;• IT Integration• Quality Management• Distribution• Serialization• Line Integration (Packaging & Manufacturing)• GS1 Standards
  5. 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. 6. TodayRegulator Perception vs. CMO/CPO Reality
  7. 7. Global Regulations
  8. 8. Perception - SimpleCustomerOrderCMO/CPOMake/PackageCustomerReceive/ShipWholesalerRX
  9. 9. RealityCMOCPOMfrA MfrBMfrCMfrDMfrEMfrFMfrGMnfHMfr IMfr JMfrK
  10. 10. State of the (Pharma) IndustrySerialization Stage*EvaluatingStrategy/ProvidersSmall PilotMulti Site Roll OutNot Started*IQPC “Pharmaceutical Serialisation andTraceability Survey”, 2012
  11. 11. CMO/CPOChallenges
  12. 12. CMO/CPO Challenges Regulatory timelines Regulatory uncertainty Conflicting demands Lack of visibilitybeyond own walls Evolving standards Serialization solutions aresystem specific Meeting multiplecustomer requirements
  13. 13. Moving Forward“A project well planned is a project already half done well.”
  14. 14. Tackling the ChallengesBe proactiveDevelop strategy and a LRPIdentify ROI and Business Value, in advanceDefine a core solutionConduct a Gap Analysis
  15. 15. 5 Point SolutionA core system that is; Flexible and scaleable Standards based Integration compatible with multiple enterprise Validation compatibility Leverages existing infrastructure
  16. 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 regulatorymandates Not if, but whenReduce integration costs
  17. 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. 18. How can PharmTech help?Michael Stewartmstewart@pharmtechinc.com(847) 281-8924 Office(815) 403-8425 Cell

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