Installation of a new Aseptic Filling Line

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Installation of a new Aseptic Filling Line

Pharmaceutical industry


Études de cas CaduceumAchievements

  • Planning of commissioning and qualification activities
  • Management of project progress
  • Review of quality documents for the different batches (production equipment and utilities): protocols, test sheets, reports and supplier documents
  • Coordination and implementation of supplier tests (FAT and SAT) for different production equipment (Isolator, E-beam, …) and water for injection (WFI)
  • Employee training

 

 

Norms  GMP Annex 15 – GMP Annex 1
Key Skills Commissioning Qualification
Type of Commitment Day to Day Basis
CaduCeum Team  1 senior consultant
Duration 5 months