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mjf34 replied to the topic Holistic Qualification in the forum Process Validation and Process Risk 8 years, 1 month ago
I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts. For example if you wanted to qualify a production line of some tablets in a bottle, all of the steps between would need to be qualified first such as: the bottle cleaner, bottle filler, tablet press, capping machine, laser etching machine, labeling machine, and the packing machine.