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Biotechnology

Engineering

Equipment, processes and utilities

From the design to the launch of the installations until their exploitation

Study on phases of Concept Engineering - Basic Engineering - Detail Engineering:

  • Processes
  • Mechanics
  • Electricity / Automation (GAMP5) / Instrumentation

Commissioning:

  • Installation tracking
  • Protocol execution
  • Troubleshooting

Production Support and Continuous Improvement

Development

FORMULATION / GALENIC / MANUFACTURING PROCESS

From development of active ingredient to Pharmaceutical Product for clinical or commercial phases.

  • Formulation
  • Pharmaceutical conditioning
  • Technology transfer:
    • from laboratory or pilot scale to commercial phase (industrialization or scale-up,
    • outsourcing / outsourcing to CMO...
  • Support / expertise in validation, process optimization

Qualification / validation

Equipment, processes and utilities

  • Qualification of equipment or utilities:
    • risk analysis (FMECA)
    • DQ / IQ / OQ / PQ protocols writing
    • protocol executions
    • report writing
  • Process validation
  • Cleaning and sterilization validation (CIP / SIP / COP)
  • Computerized system validation(CSV)

Quality support for R & D or production

  • Quality management system
  • Quality Assurance (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):
    • Analytical methods Development / Validation / Transfer
    • Stability Tracking and Trending
    • Laboratory equipment qualification

Regulated environment: GMP, GCP, GLP, ICH regulation

Submission: strategy definition, submission of marketing authorization and modules 1 to 5 writing.

Post-market: variation or maintenance, interface with the authorities Labeling, packaging, artworks …

  • R & D project management: product / process development coordination
  • Technology or production transfer
  • Project management Engineering: new works or revamping
  • Construction phase: Technical coordination and follow-up
  • Quality Project Management
  • Planning & Cost Control
  • Strategic Purchasing / Project Purchasing

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