Commissioning and Qualification

McGee Pharma International provides the following commissioning and qualification services:

  • Management of Commissioning and Qualification projects to: 
    • ensure that the key milestones of the project are identified
    • ensure that the challenges to the commissioning and qualification process are identified
    • ensure the application of Quality Risk Management to the process, in accordance with ICH Q9
    • ensure input from the Quality perspective from the beginning through to the end of the process
  • Guidance and support on preparation of documentation, including:
    • Procedures
    • Protocols
    • Reports and the associated records of actions taken or conclusions reached as part of commissioning and qualification activities
  • Ensuring that commissioning and qualification activities are completed effectively, efficiently and meet regulatory expectations and compliance

Process Validation

McGee Pharma International provides the following Process Validation services:

  • Management of Process Validation projects, providing expert inputs to ensure:
    • the application of Quality Risk Management to the process, in accordance with ICH Q9
    • the provision of guidance and support on preparation of documentation
    • validation of the process is completed effectively, efficiently and meets regulatory expectations and compliance

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