EMA’s reflection paper on AI in the pharmaceutical lifecycle
by Giuliana Miglierini The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical…
Trends for the future of the pharmaceutical manufacturing
By Giuliana Miglierini The technological evolution of pharmaceutical manufacturing towards the full implementation of the Industry 4.0 paradigm…
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…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
PIC/S Annual Report 2021
by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and…