The efficacy of a product can be affected by a variety of external factors, such as the environment in which the product is stored in along with the air, water and systems that have being utilized during the manufacturing process.
Regulatory requirements specify that all full qualification must be conducted on all aspects of facilities and utilities that may affect the product directly or indirectly. These utilities and facilities include water, ventilation, temperature and humidity systems in conjunction with coldrooms, cleanrooms, warehouses and laboratories.
As part of developing a validation master plan Autocal Ireland would ensure that all of these services have been fully validated and in accordance with these validation studies, detailed protocols, procedures SOP’s and reports would also be drafted.
Utilities/Facilities qualification services include:
- Clean room facilities validation
- DI, WFI Purified water system validation
- HVAC system validation
- Steam quality testing
Contact us here for further information.