Abstract

Validation is a required activity worldwide for confirmation of process and system acceptability. It goes well beyond inprocess and finished goods testing using independent assessments of process parameters and targeted sampling to establish definitive proof of process suitability. The activity called ‘Validation’ in the global healthcare community is based upon the classic scientific method: establishment of a premise; design of an objective means for confirming the premise; conduct of experimentation with collection of data; and preparation of a report confirming the premise.