An Application of QFD for Production Start-up of a Generic Drug in a Government-Owned Pharmaceutical Institution

摘要

The aim of this article is to present a case of QFd applied to transition from laboratory scale to preparation for production in industrial scale of a generic drug-amoxicillin-in a government owned pharmaceutical institution. This QFD application had two dimensions: work organization and QD deployment process. In the first dimension, a multifunctional team involving the various functional areas of the company was formed, and it was divided into four working fronts. In the second dimension, the teaM initiated the construction of a conceptual model of positive quality deployment. This construction work was divided into two stages: the first covered up to the final product capsule and the second covered the packaging process. Subsequently, the tables and matrices were filled up for use in generation of standards. This project contributed to early detection of problems related to product, process and raw material. Another contribution of this work is the construction of a conceptual model for developing generic drugs, which can be adapted and utilized in future projects.