EQUIPMENT AND FACILITY QUALIFICATION
Many companies assume that since process validation does not have to be completed until your product nears market production, the same is true for equipment qualification. However, the FDA and other regulators expect critical equipment qualification and sterilization validation to be completed before beginning the manufacture of any drug intended for use in humans (i.e., by Phase I).
Early qualification for validation should include:
- Autoclave load cycles
- Validation of equipment steaming cycles
- Purification skids,
- API or final product mixing tanks,
- Refrigerators or freezers, and
- Filtration systems.
Qualification must also include critical support equipment:
- Cell banking freezers
- Stability sample refrigerators, freezers, and incubators.
We have many experts in validation and qualification that can help with everything from defining a cost effective, risk based approach to writing Master Plans, protocols and final reports and executing the work.