Lea Joos

Feb 13, 2023 | outsourcedpharma.com | Peter H. Calcott |Lea Joos |Regina Choi-Rivera |Lei Zheng |Louis Garguilo

By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC The new EMA GMP Annex 1, Manufacture of Sterile Medicinal Products, 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.

Feb 9, 2023 | pharmaceuticalonline.com | Lea Joos |David Butcher |Barbara Schulz |Sandra Guerreiro

By Lea Joos, The Government of Upper Bavaria Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?