AlisPharm provides support for pharmaceutical businesses, aiding the development of medicines using our Quality and Process Engineering expertise in order to eliminate risks.

 

Puce Ap  Operational Quality Assurance

  • CAPA management 
  • Anomalies and non-conformities management
  • Proposed methods for problem solving 
  • Customer claims management.
  • Supplier Quality
  • Change control management
  • Preparation of inspections and self-monitoring
  • Creation or updating of documents dealing with production, directives, stability studies...
  • Creation and provision of training (awareness development)

 

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

  • 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