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.…
A concept paper on the revision of Annex 11
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
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…
Automation of aseptic manufacturing
by Giliana Miglierini The pharmaceutical industry is often the last industrial sector to implement many new manufacturing and…