Global Insulin Cartridge Program

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Client: Eli Lilly
Location: Global project (USA, France, China)
Scope: Pharmaceutical, Fill-Finish

Project Highlights

Define a Global Commissioning, Qualification and Validation (gCQVS) Strategy for the Global Insulin Cartridge Program, and provide governance for project-specific planning documents.  All cartridge line projects worldwide must follow this strategy in order to reach the same platform, the same control strategy and therefore the same CQV strategy ate least for the tier 1 systems. This strategy has been replicated in the other sites of the Eli Lilly global network (USA, France and China).

Services Summary

C&Q global Lead for replication strategy, support on execution of C&Q activities in the other sites part of the program for insulin manufacturing expansion.

  • Define the Global CQV Strategy for the Global Insulin Cartridge Program
  • Define the replication strategy and process for all commissioning, qualification and validation activities
  • Define the global standards, policies and procedures that govern commissioning, qualification and validation activities for the GICP
  • C&Q schedule review and multiple projects overlapping analysis for integration, support, sharing of information and global change request
  • Global C&Q coordination and management
  • Definition and reviewing of global C&Q Work Plan, User Requirements, SLIA, CLIA, COD, Alarm Rationalization
  • Development/Review of the global C&Q test cases for the core process equipment (filling, formulation, component processors)
  • Coordination and Support of onsite C&Q testing execution in Indianapolis (USA), Fegersheim (France) and Suzhou (China)

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