Raffaele Pace

Feb 7, 2023 | pharmaceuticalonline.com | Peter H. Calcott |Raffaele Pace |Kelly Stewart |Sharon Nowak

By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC The new EMA GMP Annex 1, , is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.