Investigation of Periodic Review Validation Practices on Small Scale and Vendor Process Equipment in Pharmaceutical Manufacturing in Ireland

Abstract

Integration of infrastructure and interconnection of computerised systems in pharmaceutical manufacturing in Ireland is ever-increasing. Organisations are collating data from multiple GxP (Good Practice) systems to generate large datasets from computerised systems. This collation of data is to support the drive for increased contextualisation of the entire manufacturing process for the purpose of delivering increased efficiencies and exploring new methods of production. Despite these advances, and to satisfy current regulatory requirements manual review of systems events continue to be the norm, formerly isolated systems critical to the development of pharmaceutical product can interface to archives and historians but the event logs and audit trails, crucial in maintaining compliance and quality are largely required to be manually investigated by trained personnel. This research was undertaken to investigate current practices of this type of review and capture the awareness of professionals tasked with supporting, executing or reviewing these tasks. The research also explores modern solutions, attitudes and concerns to using advanced technologies such as validated scripting tools and AI models to understand how academic research, industry practices and professionals tasked with supporting these logs for regulatory purposes feel about their use. The research also proposes a framework for the implementation of different methods of review to increase the efficiency, consistency and effectiveness of the task, to assign potential owners and distribute actions.