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