As the last step in the process of building a production plant, and once all of its facilities and production and installed machinery are finished, you need a full program of commissioning and validation of all components in order to ensure that all processes, equipment and facilities operate according to the specifications.

Commissioning - Ingelyt Clean Room Egineering

The entire process should be properly documented according to international standards in order to facilitate the approval processes of local and / or international pharmaceutical authorities.

  • Reception and commissioning of all facilities and equipment
  • Commissioner
  • USR´s definition
  • Validation Master Plan (VMP)
  • Validation IQ / OQ / PQ
  • Management of Technical Documentation
  • Approval of pharmaceutical, local authorities, EU GMP/ FDA ….