Manufacturing sites

Towards predictive and individualised medicine

Our positioning enables us to work on the overall life cycle of a health product.

Areas of expertise

Services

  • Quality Assurance (Batch releases , Change Control, CAPA Management, etc.)
  • Quality Control (Raw Materials, Micro-biology, product stability, etc.)
  • Qualification of equipment and installations (IQ/OQ/PQ)
  • Process Validation / Cleaning Validation (CIP, SIP) / IS Validation 
  • Regulatory affairs (maintaining commercial release authorisation, drafting of technical documents, etc.)

References and technical expertise

  • Qualification of formulation/production equipment and validation of a cleaning process: drafting of IQ/OQ/PQ protocols, coordination of tests and drafting of qualification reports
    Drafting of validation master plans, supervision of cleaning runs, sampling actions
  • Quality Assurance on sterile filling site: change control, release of lots, deviations, non-compliances, complaints, preventive and curative action (CAPA / risk analysis)
  • Environmental supervision on a business park: coordination of sampling campaigns, proof reading of site qualification protocols, drafting of a site supervision strategy
  • Regulatory affairs: drafting of the module 3 the recording of monoclonal antibodies, management of the GSS and drafting of external change controls

Services

  • Engineering / preliminary outline – APS / final design – APD/ Detail studies (Process, Electricity, Mechanical engineering, Civil Engineering, Instrumentation, Pipe systems, etc.)
  • Supervision / Installation on site
  • FAT/SAT, Commissioning
  • Supervision of technical shutdowns / Maintenance / HSE
  • Project management
  • Transfer / industrial conversion

References and technical expertise

  • New works project management on restoring the compliance of in-situ cleaning stations following FDA remarks. Supervision of project from the design phase up to completion, supervision of sub-contractors, FAT, SAT and commissioning of the new installation
  • Supervision of a production line transfer site, from site A to site B. Supervision of the line dismantling site, supervision of equipment transit logistics and supervision of the reinstallation site and of the commissioning of the installations
  • Supervision of technical shutdown works: planning of works, reception of sub-contractors, leading work site meetings, maintaining work site safety
  • Serialisation and aggregation project management for Brazil and China: drafting of specifications for marking and vision systems, call for tenders from suppliers, FAT/ SAT, supervision of installation

Services

  • Continuous Improvement and Lean Manufacturing (5S / Kaizen / 6 Sigma / TPM continuous)
  • Project Management
  • Planning
  • Cost Control / Contract Management
  • Risk Management

References and technical expertise

  • Operational deployment of the Lean on a production site: supervision of 5S site, setting up of visual management, updating of performance indicators, running of Lean workshops, operator training, etc.
  • Planning of industrial building construction and plant qualification processes (IQ, OQ, PQ, VP) using the MS Project software package
  • Production engineering project management (cost, quality, delivery dates) for a new self-injector not approved by the FDA
  • Cost Control on two CAPEX investment projects for the renovation and extension of an industrial building (setting up of a cost structure, management of change orders, setting up and supervision of a financial performance supervision plan, etc.)

Services

  • Purchasing of products/equipment (raw materials, packaging, industrial equipment)
  • Purchasing of services (works contract, clinical studies, transport, etc.)
  • Management of internal and external flows
  • Stock management (Kanban, etc.)
  • Development of Primary and Secondary packaging

References and technical expertise

  • Purchasing of equipment and works contracts for the construction of a new industrial site: sourcing, preliminary qualification, short list, issue of calls for tender, technical and commercial clarifications, negotiation and contractualisation
  • OPEX purchasing (production and secondary packaging) and definition of a new provisioning strategy on a medical systems production site
  • Packaging development and production engineering: development of packaging for the launching of new products, product transfer, packaging technical unification and production engineering
  • Optimisation of internal flows on an industrial site between the raw materials storage building and the production building: analysis and mapping of the flows, optimisation of logistics procedures and safety for raw materials transport

Quality policy

They trust us

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