Viewpoint: Data Integrity and Its Ties with Personal IntegrityByAllen Welsher ,James Agalloco June 21st 2021The root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
Refining Microbiological Control for Non-Sterile ProductsByJames Agalloco ,Donald SingerOctober 21st 2020Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.