Process Validation Guidance

Interesting paper

GHTF%20process%20validation%20guidance[1].pdf (180.4 KB)

This paper is from 2004, I wonder if there is an updated version that reflects ASTM, GAMP, FDA, ICH etc. directives, guidances, protocols that have come thick and heavy in the last couple of years.
springs to mind.

Now that it looks like the FDA’s New Process Validation Guidance will replace the 1987 Guidance, what happens to Medical Devices as the new draft excludes them.