Promeridian can help customers to decide their qualification strategy, from a traditional approach to an ASTM approach.
In a traditional approach, qualification of facilities and equipment may include the whole process from User Requirement Specification, to Risk Assessment, Validation Master Plan, FAT, SAT, DQ, IQ, OQ and PQ.
The following shows all the qualification deliverables that Promeridian can develop, indicating the documentation associated to each qualification step.
The following facilities, utilities and equipment can be qualified by Promeridian:
- Air treatment systems
- Clean rooms: Architecture, qualification and requalification of environmental conditions.
- Utilities: Purified water (PW), Water for injection (WFI), Pure steam (PS), compressed air and gases (nitrogen, etc.)
- Thermal equipment and facilities: Autoclaves, sterilization tunnels, freeze dryers, reactors, freezers, ovens, stoves, incubators, warehouses, cold rooms and stability chambers.
- Production Equipment
