Engineering
Equipements processes and utilities
From URS to qualification & launch and operation
Technical study on phases of Concept Engineering - Basic Engineering - Detail Engineering:
- Processes
- Mechanics
- Electricity / Automation (GAMP5) / Instrumentation
- HVAC
Mise en service :
- Suivi d’installation
- Exécution des protocoles
- Troubleshooting
Production support and continuous improvement
Development
Formulation / Manufacturing process
From Development of active ingredients to Pharmaceutical drug product for clinical and commercial phases.
- Formualtion and pharmceutical conditioning
- Tansfer :
- Industralisation and scale-up: from laboratory- or pilot-scale to commercial manufacturing
- Externalisation/outsourcing towards CMO...
- Validation support/expertise, process optimisation
Qualification/ validation
Equipments, process and utilities
- Equipment or utilities qualification: :
- Risk analysis (FMECA)
- Protocol writing (DQ/IQ/OQ/PQ)
- Protocol execution
- Report writing
- Process Validation
- Cleaning and sterilization Validation (CIP/SIP/COP)
- Computarized system Validation (CSV)
Quality support for R&D or production
- Qualitiy management system
- Quality Asssurance (QA):
- Operational QA: CAPA, deviation, change control, batch records review, investigations...
- Supplier QA
- Compliance
- Review and approval of protocols for qualification and validation
- Quality Control (QC):
- Development/ Validation/ Analytical method transfer
- Stability follow-up and trending
- Laboratory equipment qualification
Regulated environment: GMP, GDP, GLP, ICH regulation
- Regulatory strategy for all health related product and regulatory requirements adapted to each country
- AMM file writing in CTD/eCTD formats (module 1 to 5) in national, centralized (CP), Decentralized (DCP) or Mutual Recognition (MRP) procedures
- File submission, registration follow-up, answer to health autorities questions
- Regulatory maintenance (Module 3 update, variation, renewal, transfer, DMI)
- CEP/ASMF (Certificate European Product/ Active Substance Master File) writing and support
- Packaging, labelling and artworks (RPC and manual translation...) validation
- Promotional elements writing and verification
- Strategy/market access and registration (CE marking) for medical devices
- Regulatory support for clinical trial
- Regulatory watch
- Engineering Project management Engineering: new works or revamping
- Infrastructures & buildings
- Utilities (EPU, EPPI, steam ...)
- Equipment (formulation, filling, packaging including serialization-aggregation)
- Construction phase: technical coordination and execution follow-up
- R & D project management: process development & formulation
- Planning - Cost Control - Project Purchasing
- Hygiene Safety Environment (HSE): work monitoring, occupational risk management
- Quality project management: audit preparation, upgrading of a quality system
