project

CQV for a new pharmaceutical filling unit

Compliance & Remediation Life Sciences France

Context and challenges

This client is a major pharmaceutical laboratory and industry leader in insulin production. This client wanted to set up a new high-speed aseptic filling unit for insulin capsules, in order to increase its production.

The project is part of a global program, aiming at installing the same line in four different countries, using the same strategy. On this site, the project required a building extension of 5,000 m², covering 3 floors.

The client appointed Assystem to undertake the commissioning and qualification phases, the scheduling and execution of the project for HVAC and utilities.

Logo Assystem Care

Project scope

  • Commissioning and qualification for HVAC (Heating, Ventilation and Air-Conditioning) and ‘clean’ utilities (for injection water, purified water, clean steam, compressed air and nitrogen)
  • Validation of a master plan
  • Design verification, commissioning (FAT/SATs) Qualifications QI, QO and QP
  • Planning and execution of tests
  • Validation of installations by the end users
  • Analysis of the contractors’ variations: CAPA process implementation (Corrective Actions, Preventive Actions)
  • Delivery of the GMP documents (pharmaceutical regulatory requirements)

Results

  • Improvements to identify in advance potential issues for the qualification phases thanks to the upstream analysis of engineering data
  • Time and cost savings thanks to C&Q activities simplification, in particular functional testing
  • Enhancement of project follow up, thanks to the definition of efficient monthly KPIs reviewed during Steering Committees
  • Improvement in the root cause analysis thanks to the analysis of contract variations, as for the OOS and CAPA processes

in figures

5,000

m² surface area

15,000

hours

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