Friday, October 5, 2007

Equipment Qualification versus Process Validation


ISPE's Baseline Guide Commissioning and Qualification clearly states that Equipment Qualification is not the same animal as a Process Validation.

I understand that Process Validation covers and verifies the repeatability, accuracy, and precision of a process while Equipment Qualification focuses on an individual piece of equipment.


Other than the scope of the protocols, they are the exact same template. Why not then throw Equipment, Utilities, etc under the umbrella of Process Validation?

This many seem as a trivial complaint but it does not seem so small when there are six or seven different templates floating around.