Qualification and Validation

If you want to make certain that your facilities are compliant with regulatory requirements, your company needs to have validated manufacturing and control processes using qualified and validated equipment in qualified and validated premises using qualified and validated utilities.

If your infrastructure does not meet regulatory standards, or is not robustly validated at each stage, compliance will become more difficult and will take longer to achieve.

Galenisys can help you ensure that your company meets your compliance targets through:

• Training your staff (please refer to the relevant section “training”) in understanding the principles of Calibration, Qualification and Validation and the ways to proceed
• Helping your operational, engineering and quality teams establish strict protocols for the qualification of new and existing facilities, equipment, utilities and manufacturing processes
• Validating the protocols
• Contamination control
• Studying the validation report data and conclusions

Galenisys has the experience and can help you to create:

• Master Validation Plan
• Protocols definitions
• Calibration programmes and methods
• Qualification (IQ / OQ / PQ) definitions
• Report formats
• Approval stages, responsibilities and processes
• Process validation including cleaning validation
  • Galenisys can supervise the validation work, being present in on the site
  • Galenisys can study and validate the numbers that are reported by the site and the report conclusions
• Due to its extensive expertise in sterile manufacturing, Galenisys can supervise the qualification studies for sterilisation equipment and processes
• Qualification and validation of water systems
• Qualification and validation of the HVAC system
  • Filtration grades
  • Differential pressure
  • Air change rate
• Analytical methods validation

This will help ensure compliance with both industry and regulatory standards and assure consistent performance in everyday operations.