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Quality management system

A comprehensive Good Manufacturing Practice compliant quality management system for the in house production of ATMP.

ATMP are medicinal products. Thus the production of ATMP has to comply with Good Manufacturing Practice (GMP) standards. A GMP-compliant comprehensive quality management system is operational, ensuring that all applicable quality and safety rules for the in house production of ATMP are met.

The quality management system includes:

  • Training and qualification of personnel.
  • Selection and qualification of raw materials.
  • Document control.
  • Process validation.
  • Validation, maintenance and calibration of equipment,
  • Environmental monitoring of the clean rooms.
  • Release of ATMP end products by a Qualified Person.
  • Internal audits.
  • Registration of errors, accidents and adverse events.
  • Participation in external proficiency testing programs.

In addition, written policies regarding processing, quality controls, storage, release and transport of cell and gene therapy products are operational.