Sumitomo Dainippon Pharma Annual Report 2017

PlantsDate of acquisitionAcquisition of ISO 14001 CertificationWe consistently conduct “untainted transactions that are balanced, fair and transparent” based upon Sumitomo Dainippon Pharma’s Ethics in Procurement. To provide high quality pharmaceuticals, we promote “stable and secure procurement” and perform CSR procurement together with our business partners.When partnering with companies for the first time, we make selections according to the standards outlined in our Criteria for Selecting new Business Partners. These criteria provide both the standards for selecting new business partners on the basis of their CSR activities in the areas of compliance, trustworthy business activities, social contribution, information management, respect for human rights, and environmental protection and consideration and the details to be fully evaluated related to the CSR activities of business partners. We also conduct regular evaluation of our business partners in accordance with the criteria by inspecting their plants, paying visits, and conducting interviews.Moreover, we provide internal lectures on the Act against Delay in Payment of Subcontract Proceeds, etc. to Subcontractors and the Customs Act to relevant departments, with the aim of strengthening company-wide compliance.CSR ProcurementPackaging and label designs for pharmaceuticals are highly regulated, including the display of information stipulated by law. In this situation, the packaging and labels for each company’s products are becoming quite similar, and this has become a cause of drug mix ups.Therefore, Sumitomo Dainippon Pharma is promoting initiatives to respond to the needs of medical institutions and patients such as highly distinctive packaging and improving the design of labels with aim of preventing medical malpractice. When it seems likely that a mix-up will occur, we respond promptly in such ways as changing the name and design so that mix-ups do not occur based on consultation with company marketing the other product.In fiscal 2012, we were the first in our industry in Japan to adopt a mechanism to allow product names to be laser printed onto the lids of bottles containing tablets on the production line. This has increased convenience for medical institutions by making it easy to remove medicines from the drawers they are stored in.We have also taken other steps from the perspective of patients, such as improving PTP sheets with an emphasis on usability, and printing the product name on tablets of our major products.Prevention of Medical MalpracticeThe three plants in Japan have obtained ISO 14001 certification, the international standard for environmental management systems. We continue to reduce production costs and conduct ecofriendly production activities through the automation of facilities and other laborsaving measures, the optimization of production sites, appropriate inventory control and the introduction of co-generation systems.We also promote industrial safety and health management in order to operate without accidents and disasters based on the thorough observation of compliance.Initiatives for environment conservation andindustrial safety and healthThe production of pharmaceuticals requires a high level of quality assurance. Consequently, rigorous GMP standards have been established in many countries. Sumitomo Dainippon Pharma’s products are exported around the world with the approval of the government organizations in the importing countries, including the FDA (U.S. Food and Drug Administration), the EMA (the European Medicines Agency) and the TGA (Australia’s Therapeutic Goods Administration), and the GMP of Europe and the U.S. has become the operational standard for the Sumitomo Dainippon Pharma Group. Furthermore, we have established a high level of facility design and quality assurance systems that pass audits by overseas partner companies and meet strict quality standards at the global level such as guidelines from the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), which deliberates on the harmonization of EU, U.S. and Japanese pharmaceutical regulations.The standards for quality assurance are expected to become increasingly rigorous. Sumitomo Dainippon Pharma Group is therefore making proactive investments in manufacturing facilities—including the new solid dosage form facility and RABS (restricted access barrier system) that increases the level of sterility assurance—to meet future standards. We are focusing our efforts on strengthening our supply system to continue providing pharmaceuticals with higher quality.Quality assurance system that supports safe andsecure productsSuzuka Plant(Suzuka City, Mie Prefecture)December 2000 certification acquiredIbaraki Plant(Ibaraki City, Osaka Prefecture)July 2000 certification acquiredOita Plant(Oita City, Oita Prefecture)March 1998 certification acquired30Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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