Manufacturing sites
Towards predictive and individualised medicine
Our positioning enables us to work on the overall life cycle of a health product.
Vakgebieden
Services
- Quality Assurance (Release of Lots, 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) / Validation IS
- 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
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Quality Management System
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Health, Safety, Environment