Equipment & Processes

Equipment and Process Qualification

  • Qualification according to European regulatory requirements and GMP standards: CQ, IQ, OQ, PQ
  • Functional analysis and value assessment
  • Risk analyses such as FMEA, Ishikawa diagram, and 5W1H method
  • Reliability and maintainability assessments for equipment and processes
  • Process validation according to European and GMP requirements, following validation master plans and test protocols
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