Delivery Process

Ensuring the facility and systems perfom as specified.

Commissioning:

  • Defines and controls all commissioning activities 
  • Performed for non-GMP systems
  • A test manager manages the commissioning activities

Qualification:

  • Qualification SOP's
  • Validation Master Plan (QMP)
  • Design Qualification (Design Reviews)
  • Factory Acceptance Testing (FAT)
  • Installation and Operation Qualification (IQ and OQ)
  • Deviation Handling and Change Control

 

Commissioning

Pharmadule Morimatsu AB  |   DanvikCenter 28  |   SE - 131 30 Nacka  Sweden  |   Phone: +46 (0)8 587 42 000  |   Email: info@pharmadule.com