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Project

New Aerosol Facility

Location

Spain

Description

Validation & Qualification Services

One of the main world inhalers manufacturer built a new aerosol facility next to the existing site.

Telstar managed all the validation & qualification efforts, developing all the life-cycle validation deliverables, from URS to PQ. The different suppliers were also involved since the beginning in order to guarantee the fulfilment of Quality Requirements. Quality Risk Management approach was applied throughout the project. Decisions on the scope and extent of validation & qualification were based on a justified and documented risk assessment of the facilities, equipment and utilities scope of the project.

Scope

Validation Master Plan, Validation plan for each system,  Risk Assessment, URS, Commissioning for non-GMP systems, DQ, FAT, IQ, OQ, PQ, Traceability Matrix  and VPR (protocols, reports and execution) for the following systems:

  • Cleanrooms
  • HVAC
  • Clean Utilities (WP, WFI, PS, Compressed air, Nitrogen, Vacuum Systems and Gases).
  • SCADA, Production Systems, WMS, HMS, LIMS, Access Control System