Facility Qualification
From WikiBioPharm
- Facility Qualification
- The process by which facility suitability is examined and documented.
Facility Qualification encompasses the inspection of the manufacturing areas to ensure the rooms are:
- Walls, floors, and ceilings are made from appropriate materials and finish to allow for adequate cleaning
- All required utilities are available and qualified if necessary (very often done in a different protocol, but referred to in the facility protocol(s)).
- Of suitable size for processes and operations within
- Windows and Doors are of the proper construction, operate if applicable, and are in the proper location.
- Drains are adequate for application
- Lighting is adequate
