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

Quality Engineering vol. 16 issue 1 - September 2003

Abstract: [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.

Keywords: Case study - Chemical and process industries - Food and Drug industry - T2 control chart - Process control optimization - Statistical process control (SPC) - Multivariate control charts

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