Qualification
Qualification should be completed before process validation is performed
A logical, systematic process followed
Start from the design phase of the premises, equipment, utilities and equipment
Major equipment and critical utilities and systems normally require IQ, OQ and PQ
6. Qualification
6.1 Qualification should be completed before process validation is performed.
The process of qualification should be a logical, systematic process and should start from the design phase of the premises, equipment, utilities and equipment.