“Qualification” and “Validation” are two words that are used interchangeably throughout the pharmaceutical and medical device industry at all levels.
In layman’s language, the terms mean checking and testing equipment and processes. Then document these tests to prove consistent performance. The idea is to establish a documented paper trail with multiple signatures from all relevant departments.
However, there are differences between them. Validation and Qualification are essential components of the same concept and in general, follow similar underlying principles.
However, the term qualification is normally used for equipment and utilities, and the term validation is used for processes.
Here is a “Rule of Thumb” 👍
- Things are qualified (equipment, pipework, instruments, utilities and ancillary systems)
- Things that are validated (manufacturing process, cleaning, computer systems and tests)
And if you need to learn how to develop an IQ IQ PQ equipment qualification protocol, check out our Equipment Validation (IQ OQ PQ) Training Course – For Starter Validation, CQV and C&Q Roles.