Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company - ERP Spain.com - España y América Latina

Establishing a personnel monitoring (PM) program requires a risk-based approach per the current EU Annex I. Presently, there is no specific industry or regulatory guidance on how to establish sample locations and sampling frequencies using Quality Risk Management (QRM) for personnel monitoring and the methodology behind a risk-based approach can vary greatly from site to site. Implementing a global risk-based methodology is desirable for consistency.  Takeda has developed a global personnel monitoring risk assessment tool that can be used across a range of production facilities.  This tool applies to both gowning qualification sample site determination and routine personnel monitoring associated with batch production.  Utilizing QRM principles, contamination hazards and sources were identified and assessed to inform risk scoring criteria.  The personnel monitoring assessment takes into consideration the process understanding of both gowning and manufacturing operations. A case study for the application of the risk-based tool will be presented.