EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection

By Louise Uí Fhatharta, Manager/Consultant at PharmaLex

Recently, industry leaders and regulatory experts gathered at a collaborative event hosted by NIBRT and Cencora PharmaLex in Dublin to dissect the nuances of Annex 1 implementation. This sold-out event, held on May 9, 2024, underscored the urgency and complexity surrounding Annex 1, which came into effect in August 2023.

Discussions at the event revolved around practical strategies for achieving and maintaining compliance amidst evolving regulatory expectations. Key highlights included insights into Annex 1 gap assessments, emphasizing their integration into Quality Management Systems (QMS) and the imperative of rigorous risk assessments and Corrective and Preventive Actions (CAPAs). Attendees also grappled with ambiguities in interpreting the guidance, particularly in sectors like ATMP manufacturing, highlighting the need for clarity and proactive adaptation.

As pharmaceutical facilities navigate the path to Annex 1 compliance, these discussions illuminate essential practices and challenges, ensuring readiness for stringent inspections and safeguarding production integrity.