The US FDA and other regulatory bodies requirements are continually evolving, so it is crucial to maintain a current understanding of the CQV development in order to maintain compliance.

We can support you across the full validation lifecycle of your manufacturing process including equipment, systems and facilities.

We have significant experience in the qualification of the following systems and equipment to ensure compliance with International Standards and Regulatory requirements including ICH and PIC/S:

• Active Pharmaceutical Ingredient (API) manufacturer
• Facility Qualification
• Cleanroom and Associated HVAC System Qualification
• Clean Utilities (Water & Steam)
• Utility Gases and Compressed Air
• Aseptic Filling Lines (Vial, Ampoule and Pre-Filled Syringe)
• Solid Dose Manufacturing Equipment
• CIP/SIP(Cleaning In Place)
• Sterilization processes (Autoclaves, Depyrogenation, VHP & ethylene oxide systems, and UV systems)
• Visual Inspection (manual and automated processes)
• Packaging equipment
• Process validation
• Cleaning validation
• Thermal mapping

From User Requirements Specification (URS), risk and impact assessments through to qualification protocols (DQ, IQ, OQ, and PQ), Requirements Traceability Matrix (RTM) development, and Final Summary Reporting. Cloud 9 Consulting Ltd. can develop and execute the full validation lifecycle documentation for your projects.