project

Processes and equipment’s validation for the production of vaccines

Compliance & Remediation Life Sciences Belgium

Context and challenges

This customer is one of the leaders in the biotechnology industry, with several vaccines production sites in Belgium.

To keep their equipment and processes in a validated state, this customer wanted to rationalise this recurring validation activity by outsourcing the coordination and execution of validation of its Manufacturing Performance Unit (MPU) and New Product Introduction (NPI). The scope of the services concerns the upstream and downstream stages of processes, spread over three production sites.

This customer assigned to Assystem the coordination and execution of activities related to processes and equipment’s validation, for the production of vaccines.

Project scope

  • Deployment of a unit to handle the whole continuous validation activity, unit directly integrated within NPI
  • Scheduling and organisation of validation activities according to the schedule of new product introduction projects and continuous revalidation needs
  • For each NPI project and for continuous revalidations:
    • Taking the validation plan into account, creating the input data folder
    • Writing the QP (Quality Performance) protocol
    • Coordinating the execution of QP tests with the production
    • Defining and managing the coordination of deviations related to the tests
    • Writing the QP report
  • Reporting to the MPU management with dashboards and KPIs (OTD - On-Time Delivery, OQD - On-Quality Delivery, etc.)
  • Setting up and coordinating continuous improvement processes to optimise recurring activities

Client benefits

  • Demonstrating the feasibility of outsourcing this activity in the form of a flat-rate service contract using unit of work-based pricing, and acting as a model for good Customer-Supplier relations based on a commitment to deliver results
  • Increased productivity and better scheduling of activities, in coordination with all departments concerned
  • Optimisation of communication between entities thanks to setting up a reporting involving several levels with KPIs presented regularly to the NPI validation manager and to the MPU management
  • Implementing productivity improvement measures, by:
    • Optimising the organisation and interactions
    • Reducing the causes of non-quality
    • Identifying the real charges and costs per deliverable

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