AlisPharm provides support for pharmaceutical businesses, aiding the development of medicines using our Quality and Process Engineering expertise in order to eliminate risks.
Operational Quality Assurance
Anomalies and non-conformities management
Proposed methods for problem solving
Customer claims management.
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)
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
Process validation (cleaning, sterilization, disinfection, manufacturing, formulation, visual distribution inspection)