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Application of the Multivariate T(2) Control Chart and the Mason-Tracy-Young Decomposition Procedure to the Study of the Consistency of Impurity Profiles of Drug Substances

Summary: [This abstract is based on the authors' abstract.]The impurity profile of a drug substance is a quality characteristic of paramount importance. However, it is usually multivariate and complicated by relationships among the impurity levels that prevent separate analysis of impurities by multivariate statistical procedures. A case study from the chemical and pharmaceutical industry shows that application of the multivariate T(2) control chart and the Mason-Tracy-Young decomposition procedure can provide several benefits in the manufacture of drug substances.

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  • Topics: Statistical Process Control (SPC)
  • Keywords: Case study,Chemical and process industries,Food and Drug industry,T2 control chart,Process control optimization,Statistical process control (SPC),Multivariate control charts
  • Author: Gonzalez-de la Para, Mario; Rodriguez-Loaiza, Pilar
  • Journal: Quality Engineering