Automated Decision-Making Tool That Determines the Most Economic Sampling Plan for Process Validation of Pharmaceutical and Biomédical Products.

This paper proposes an automated digital system for the selection of the most cost-friendly process validation sampling plan. The system is based on the US Food and Drug Administration's mandates and other standardized procedures. The algorithm is designed to deliver one output as a function of mult...

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Detalles Bibliográficos
Publicado en:Journal of Validation Technology (JVT) Vol. 17; no. 4; pp. 76 - 81
Autor principal: Gola, Andres I.
Formato: tables/charts Journal Article
Publicado: Institute of Validation Technology Autumn2011
Acceso en línea:Ver este registro en EBSCOhost
Descripción
Sumario:This paper proposes an automated digital system for the selection of the most cost-friendly process validation sampling plan. The system is based on the US Food and Drug Administration's mandates and other standardized procedures. The algorithm is designed to deliver one output as a function of multiple input parameters without further interaction with the users. The system will reduce any possible subjective elections and will make the output a completely objective and quantitative result.