Quality Unit

Expertise and services

The Quality Unit is responsible for the quality-management system supporting the Department for Cell Therapy’s activities. A new Unit Leader is to be appointed, while Cecilie Nguyen currently serves as Quality Manager.

The Unit has competence in GMP quality assurance, quality-risk management, qualification, validation and regulatory compliance for cell and gene therapy. It supports both established stem-cell activities and the development and manufacturing of ATMPs.

Services and responsibilities include:

  • maintenance and development of the pharmaceutical quality system; 
  • document control and approval of controlled procedures; 
  • management of deviations, corrective and preventive actions; 
  • change control; 
  • quality-risk management; 
  • qualification of rooms, equipment, suppliers and systems; 
  • validation oversight; 
  • review and approval of manufacturing and QC documentation; 
  • training and competence-management oversight; 
  • internal audits and inspection readiness; 
  • supplier and material qualification; 
  • quality agreements; 
  • support for regulatory submissions and inspections; 
  • environmental-monitoring oversight and trend review; 
  • oversight of data integrity and traceability; 
  • approval of significant changes affecting GMP-classified areas. 

The Quality Unit verifies that equipment, premises and procedures comply with current regulatory requirements and supports the safe and consistent manufacture of therapeutic cell products. 

Location and capacity

The Quality Unit is integrated into the Department for Cell Therapy on the first floor of the Research Building at Radiumhospitalet.

Its functions span:

  • offices within the Department’s administrative area; 
  • Grade D QA/QC rooms adjacent to the manufacturing areas; 
  • document and quality-management systems covering the full facility; 
  • oversight of the BSL-1 and BSL-2 cleanroom areas; 
  • oversight of storage, cryopreservation and supporting technical areas. 

 

Main equipment and systems

The Quality Unit primarily uses quality-management and monitoring systems rather than manufacturing equipment. Relevant systems include:

  • electronic document-management systems; 
  • training and competence-management systems; 
  • deviation, CAPA and change-control systems; 
  • equipment and maintenance registers; 
  • environmental-monitoring systems; 
  • temperature-monitoring and alarm systems; 
  • calibration and qualification records; 
  • audit and inspection-management tools; 
  • risk-management and validation documentation systems. 

The Unit also oversees the qualified use of analytical and manufacturing equipment throughout the Department.

 
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