O papel do Quality by design na cadeia de suprimentos desverticalizada e globalizada da indústria farmacêutica

Abstract

Pharmaceutical industries operate under several organized relational arrangements, in a geographically dispersed manner, tightly regulated and globally coordinated. Production processes can be shared by company headquarters and its subsidiaries, or even with two or more different organizations contracted in the same country or in different continents. Multiple derivative partnerships (technology transfer, technology partnerships, contracting of services, joint development, etc.), established inshore or offshore, incur greater quality risks. Based on the conceptual framework research of Quality by Design, the central issue: “if and how this artifact provides real coordination gains in the context of the current outsourced configuration of pharmaceutical supply chain, thus promoting superior articulation among the agents” was postulated. Integration of the central theme, with other theoretical approaches, was also explored and supported by literature review, a research protocol was developed and addressed to experts in the pharmaceutical industry, who ratified the complexity of the contemporary outsourced landscape and understand in that the Quality by Design approach is of great relevance in the improvement of processes and products, sharing knowledge and reducing quality risks, with the potential to minimize transactions asymmetry, as well as reducing costs of coordinating pharmaceutical supply chain.