Current Biotechnological applications are set to stay for the long-term and will become increasingly important in the near future.

AlisPharm, backed by its accomplished quality vision, helps businesses in the development and implementation of these increasingly specific and dependable technologies.

Puce Ap Operational Quality Assurance

  • Corrective Actions and Preventive Actions (CAPA), abnormalities and deviations management
    • Change control management
    • Customer complaint management
    • Environmental monitoring
    • Supplier quality
    • Inspection preparation and auto-inspections (notified bodies, suppliers, FDA…)
    • Gap analysis
      • Alignment and standardization of procedures (MQS)
      • Document management (instructions, tests, operating procedures …)
      • Personnel training Management

 

 

Puce Ap Reliability of processes and systems

  • Risk analysis management
  • Commissioning, qualification and initial validation of equipment (production, packaging and control), rooms and facilities (e.g. autoclaves, washing machines, production systems, facilities, filling machines, environmental systems, special machines, 
  • Qualification and Validation of Quality Control systems (analytical method, microbiological, etc.)
  • Systems reliability enhancement (equipment and processes)Risk analysis, continuous improvement, retrospective / periodic qualification and validation
  • Validation of computerized systems

Puce Ap Process engineering

  • Definition of validation strategies: master plan
  • Process validation (cleaning, sterilization, disinfection, manufacturing, formulation, visual distribution inspection)
  • Industrial transfer
  •  Analytical methods transfer
  • Development of products / processes
  •  Galenic Development
  •  Project Management: Equipment sizing, URS (user requirement specification) redaction, design qualification/ choice of suppliers, supplier management