From experimental design to quality by design in pharmaceutical legislation

Quality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of manufacturing problems are quickly corrected.