Qualification

 

Qualification from IQ to PQ

In addition to performing the initial qualification, SKAN also provides requalification of pharmaceutical equipment:

  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ) of the H2O2 process
  • Requalification

The SKAN qualification team provides qualification services for SKAN equipment, as well as for equipment from other manufacturers. SKAN has its own equipment management system for the testing instruments, to ensure that they are always available without delay

Qualification experts

The qualification is based on international standards and cutting-edge scientific research:

  • GAMP standards
  • GMP
  • SKAN SOP's
  • Customer requirements
  • Documentation can be adapted to meet customer requirements

From DQ to PQ: SKAN offers expertise

  • Microbiological qualification (MBQ)
  • Factory acceptance test (FAT)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Decontamination cycle development (CD)
  • Process qualification (PQ)
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