Once the typology of the product is defined, the selection of the technology is critical for each phase of the productive process, as the correct selection of equipment, plant sizing and finally the correct definition of the processes.
Ingelyt as part of the project, can collaborate with the client from the selection of equipment both manufacturing and analytical, to start up, approval and training in a productive area, as well as writing all regulatory documentation (Module 3) for inclusion in a dossier of records.
Finally Ingelyt cancoordinates in a global way all the needed requirements (facilities, equipment, support documentation, transfer protocols and regulatory changes) for the transfer of a product from one plant to another.
In summary, it can support all these activities:
- Making the required USR equipment for both manufacturing and analytical processes
- Selecting the most appropriate technology for all processes both manufacturing and analytical
- Comparison of technical equipment available on the market for both manufacturing and analytical processes
- Making FAT and SAT of the selected equipments
- Accomplishment of protocols DQ, IQ, OQ, PQ of the selected equipments
- Accomplishment of SOPs for equipment (use, cleaning and maintenance)
- Calibration Plans
- Definition and theoretical training on the main parameters in the process
- Training in the use of equipment both process and analytical ones
- Support at the start of equipment during commissioning, scaled or validation process
- Support for transfer of products from one manufacturing plant to another