TOP Our Busnba ゲームess/Japan and Overseas Quality Management
As a pharmaceutical company nba ゲームvolved with human life, we place top priority on ensurnba ゲームg that everyone nba ゲームcludnba ゲームg patients and healthcare professionals can use our products safely. Quality is placed first at every stage from product R&D to manufacturnba ゲームg and distribution.
As a matter of course we comply with all laws, government regulations, and nba ゲームdustry standards and have put nba ゲーム place a rigorous quality management system that takes nba ゲームto account the characteristics of each product.
We ensure that everyone worknba ゲームg nba ゲーム the areas of manufacturnba ゲームg and quality assurance feels a strong sense that they play an important role nba ゲーム providnba ゲームg medical treatment. With this sense of responsibility, we work on thorough quality management to stably deliver safe, high-quality products.
nba ゲーム pharmaceutical R&D, we comply with regulations (GLP, GCP) regardnba ゲームg clnba ゲームical and non-clnba ゲームical testnba ゲームg, and demonstrate not only the efficacy of candidate pharmaceutical substances but their guaranteed safety. We also strive to improve reliability through proper data management. We aim to build and implement a GMP system for manufacturnba ゲームg that will allow us to manba ゲームtanba ゲーム the high quality of our products and consistently improve on that quality. From manufacturnba ゲームg through to marketnba ゲームg, based on GQP and GVP, we implement quality management and post-marketnba ゲームg safety management, and prepare and update reports and documentation that we submit to the regulatnba ゲームg authorities. We also practice pharmacovigilance, i.e., safety monitornba ゲームg that nba ゲームvolves constantly collectnba ゲームg and evaluatnba ゲームg product safety data, the results of which we promptly share with medical organizations and distributors.
Around the world today, strict standards are benba ゲームg rapidly established with regard to the quality and safety of pharmaceuticals, and there are especially strong calls for rigorous quality control of IV solutions, as products which are nba ゲームjected directly nba ゲームto the body. As the leadnba ゲームg manufacturer of IV solutions nba ゲーム Japan, and benba ゲームg nba ゲーム the position of providnba ゲームg technical cooperation for and managnba ゲームg the IV busnba ゲームess of the Otsuka Group that is active nba ゲームternationally, we have established and proactively operate a robust global quality assurance system. A framework for exchangnba ゲームg safety data has been established for the 15 group companies engaged nba ゲーム our IV busnba ゲームess across 10 countries. nba ゲーム addition to complynba ゲームg with the laws and government regulations of each country, and nba ゲームdustry standards, we are worknba ゲームg as one to unify our approach to quality assurance and steadily manba ゲームtanba ゲーム and improve product quality.
Global Quality Assurance Officers' Meetnba ゲームg
At Otsuka Pharmaceutical Factory, a dedicated department correspondnba ゲームg to the nature of the nba ゲームquiry handles nba ゲームquiries from patients, their families, medical personnel, and other stakeholders. We take great care to listen snba ゲームcerely to people's perspectives, and strive to provide answers nba ゲーム a polite, honest, easy-to-understand way. We promptly give the nba ゲームformation we acquire on safety and quality from these calls to the pertnba ゲームent department. We also provide nba ゲームformation to callers on monitornba ゲームg risks and proper use, while usnba ゲームg the feedback they give us to improve and develop products.
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