fo edoCitcarP fo edoCstnemsksir rehtOtraped eecitcarPeetti ec●Maruho shall construct an international standard quality management ageLisnopseRlbmmoC.tpeD l35(As of September 2021)Basic approachExecutives and employees shall comply with the Maruho Code of Compliance Standards in their own conduct and their business activities.Its Fundamental Policy declares as follows: our mission, as one who handles pharmaceutical products, i.e., products that impact health and life, is to contribute to a high quality of life and the health of people. For that purpose, in carrying out business activities, we shall comply with general laws and regulations such as civil codes, corporate laws, and anti-monopoly laws, as well as the various business-related laws and regulations such as pharmaceutical laws, GLP, GCP, GMP, GQP, GVP, and GPSP*, and will have no relationships with antisocial forces and groups and adamantly refuse and oppose their unreasonable demands. We shall act with high ethical standards, including bioethics, and good sense, and each individual shall conduct themselves with self-awareness and an understanding of one’s own mission. When we commission work to Group companies or outside vendors in regard to various processes, such as product research, development, manufacture, and sales, we shall be aware that we are the ones that bear the ultimate responsibility, and shall handle situations with a sense of unity with the Group company or outside vendor.Promotion systemsAt Maruho, the Risk Management Committee plays the central role in activities to promote compliance. The Risk Management Committee designates risks that require Companywide control* and instructs the Code of Practice Committee and responsible departments to control such risks by the PDCA cycle approach, with the aim of promoting compliance in an integrated manner throughout the Company.* Compliance risk related to the Code of Practice and the like, and other risks* GLP (Good Laboratory Practice): Standards to ensure the safety and appropriateness of facility equipment/devices, organization/staff, examination/procedure/results, etc., of non clinical tests GCP (Good Clinical Practice): A ministerial order providing the standards that companies and medical institutions should comply with in conducing clinical tests of drugs GMP (Good Manufacturing Practice): Standards for manufacturing control and quality control of pharmaceuticals and quasi-pharmaceutical products GQP (Good Quality Practice): A ministerial order concerning standards for quality control over pharmaceuticals, quasi-pharmaceutical products, cosmetics, and regenerative medicine products GVP (Good Vigilance Practice): Standards that manufacturers and sellers of pharmaceuticals, quasi-pharmaceutical products, cosmetics, or medical devices shall comply with regarding the collection and examination of information related to the quality, effectiveness, and safety of, and for the proper use of, the products, as well as the matters related to necessary measures based on the results thereof GPSP (Good Post-marketing Study Practice): Standards for studies and tests after manufacture and sales* PQS (Pharmaceutical Quality System): A comprehensive model of an effective pharmaceuticals quality system for pharmaceutical companies, applicable to different stages of the product life cycle. It is aimed at “establishing and maintaining the proper product quality,” “establishing and maintaining a controlled state,” and “promoting continuous improvements.”The quality policy of Maruho Co., Ltd. is to provide a stable supply ofpharmaceutical products together with science-based information to people of the world who wish for good health.●With a global perspective, Maruho shall strictly comply with all relevant quality-related laws and regulations.●Maruho shall gather information on medical needs and create innovation to provide pharmaceutical products and information of superior quality.system (such as PQS*) to promote continuous improvement toward a higher level of quality.●Maruho shall properly allocate operational resources in order to realize this quality policy.[Promotion System]All employees[Risk Management Committee]ChairpersonDirectors(excluding outside directors)Committee secretariatCompliance manager registered at JPMAComplianceQuality policy
元のページ ../index.html#37