AstraZeneca’s Initiatives for Prospective Harmonization Pilot Program for Drug Substance and Drug Product Monographs by the JP and USP

Abstract

 AstraZeneca participated in the Japanese Pharmacopeia (JP) and United States Pharmacopeia (USP) Prospective Bilateral Harmonization Pilot Program for drug substance and drug product monographs as part of efforts toward international harmonization of pharmacopoeial standards. AstraZeneca is creating monographs for “Dapagliflozin Propylene Glycolate Hydrate” and “Dapagliflozin Propylene Glycolate Tablets” with the aim of international harmonization of pharmacopoeial standards. The aim of this initiative is to reduce various burdens and improve the efficiency of global supply chains, and it examined the benefits and challenges for companies. Specifically, AstraZeneca responded to technical and regulatory challenges by establishing new identification tests, introducing streamlined descriptions, unifying general test methods, and examining system suitability. This pilot program served as a model case showing the potential for expanding international harmonization of pharmacopoeial standards and provided a valuable opportunity for companies to directly participate in international harmonization activities. Through this initiative, AstraZeneca hopes to ensure quality of pharmaceuticals and stable product supply, and to serve as a pioneer in international cooperation and harmonization of pharmacopoeial standards.