House Guides—an Application of Basic Statistics in Pharmaceutical Quality Control

Abstract

Experience has shown that It is virtually impossible to assign limits for the release of pharmaceuticals by a single formula. The House Guides System is a method for assigning release limits which takes into account many of the significant variables. Assays are grouped into three categories by the statistic EVAL which is a function of assay precision, process variation, component stability, and width and symmetry of product specifications. Release limit formulae are assigned to the three respective groups in such a way as to achieve reasonable confidence limits.