PMO and ASTM E2500 approach for a biopharmaceutical group

Compliance / Security Life Sciences Switzerland

Context and challenges

The client a is a global biopharmaceutical company, with a focus on neurology and immunology.

It has launched a global program to increase its production capacity and process reliability. This project, which aims to optimize project management, requires a shutdown with a minimum impact on the production capacity & volume delivery. The overall planning is being optimized to reduce the shutdown period.

The ASTM E2500 strategy is known on site but partially deployed. The handover, with the reception of the new equipment by the production users, has to be formalized.

Assystem Care has been appointed to evaluate the client practice in project management, including planning, risk analysis and quality, and improve industrial organization strategy.

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Project scope

  • Diagnostic of project management practices including time, cost and quality criteria
  • Determination of critical path with main suppliers and customer
  • Preparation of 4-level planning to establish a realistic and robust technical shutdown duration
  • Organisation of a sub-projects for planning management
  • Delivery of a project risk analysis, including financial control, maintenance and safety activities
  • Support for resources management and organisation improvement


  • Full ASTM E2500 deployment without any troubleshooting and no planned rework
  • Organisational improvements to manage external and internal workload
  • Successful handover of transfer activities from qualification phase to production management
  • Reduction in shutdown duration (25 weeks vs 26 weeks planned)
  • Delivery on time of 100% batches produced in post project

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