McClellan on PAT
This article was originally published in The Tan Sheet
Executive Summary
FDA will publish draft guidance on process analytical technology in September, Commissioner Mark McClellan, MD/PhD, tells Product Quality Research Institute workshop participants on Aug. 5. "I hope you will all have a chance in September...to read our new guidance document that we will be releasing on the use of process analytical technology in making possible innovations in drug manufacturing and quality assurance," he says. The draft guidance is expected to draw from the agency's existing guidance on 21 CFR Part 11 electronic record/electronic signatures (1"The Tan Sheet" Oct. 28, 2002, p. 12)...