The ICMRA collaborative hybrid inspection pilot (CHIP)
by Giuliana Miglierini Hybrid inspections emerged during the pandemic as a new way to approach the assessment of…
EC Communication (part 2): a Critical Medicines Alliance to support European pharma supply chain
by Giuliana Miglierini After last week’s examination of the first part of the Commission’s Communication, specifically targeted to…
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.…
EDQM, the RTEMIS scheme for remote inspections and new application forms for CEPs
by Giuliana Miglierini Starting in 2022, the Real-Time Remote Inspections (RTEMIS) programme, established by the European Directorate for…