ECA’s guide to compliant equipment design By Giuliana Miglierini The legislative evolution of the last decades emphasised requirements for equipment used in pharmaceutical productions.…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
FAT and SAT, a critical step for the introduction of new equipment by Giuliana Miglierini There are two key moments to be faced to introduce a new piece of equipment…