Qualification: Qualification is objective evidence that equipment or system and its ancillary systems are correctly installed, work as expected, and fit for the intended use. -Crux of all definitions Validation: Validation is the collection and assessment of data from process design to commercial phase, ...

1 According to GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that critical aspects of their specific operations are controlled. 2 The key elements of a company’s qualification and validation program should be clearly defined and ...