Cpo cmo serialization back to school
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The document outlines strategies for Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs) to navigate the challenges of serialization in the pharmaceutical industry. It highlights the regulatory landscape, existing difficulties such as regulatory uncertainty and evolving standards, and proposes a five-point solution to enhance integration and scalability. Next steps include conducting a gap analysis and mapping processes to identify efficiencies and align with customer requirements.
Cpo cmo serialization back to school
- 1. SchoolSerialization for Pharma CMO/CPO’s Back to How to survive and thrive in the era of serialization
- 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
- 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
- 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