At Rohto Group, in order to deliver safe, secure, and high-quality products to customers around the world, we have implemented and operate quality management systems at our manufacturing bases both domestically and internationally, tailored to the characteristics of our business and the regulatory requirements of each country and region.
At the Ueno Techno Center, the Rohto Group's manufacturing, quality control, and logistics base, we operate a quality information management system compliant with FDA Part 11 *1. By centrally managing test data using the Quality Information Management System (LIMS), we ensure data reliability and efficient quality control. In addition, we have obtained ISO 13485 *2 certification and, for products destined for Europe, we comply with CE marking *3 requirements, demonstrating our commitment to meeting the quality and regulatory requirements demanded in the global market.
Regarding ISO 13485, the following companies have obtained certification: Ueno Plant, Osaka Plant, The Mentholatum Company, Ltd. (UK), Mentholatum (China) Pharmaceuticals Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam) Co., Ltd., Mono Vienna, and Mono Hornstein.
Furthermore, regarding ISO 9001 *4, the international standard for quality management systems, DAX Cosmetics Sp. z o.o., The Mentholatum Company South Africa, Mentholatum (China) Pharmaceuticals Co., Ltd., Rohto-Mentholatum (Vietnam) Co., Ltd., Wen Li, and Eu Yan Sang (Hong Kong) Limited have obtained certification. Each location continuously operates and improves its quality management system in accordance with international standards, striving to maintain and improve the overall quality assurance level of the group.
Furthermore, our pharmaceutical manufacturing plants adhere to GMP (Good Manufacturing Practice) *5 standards for manufacturing and quality control, striving to deliver safe, reliable, and consistently high-quality products.
*1 FDA Part 11: Standards established by the U.S. Food and Drug Administration (FDA) regarding the management of electronic records and electronic signatures.
*2 ISO 13485: An international standard for quality management systems specific to medical devices.
*3 CE marking: A mark indicating that a product conforms to the safety, health, and environmental protection requirements stipulated by relevant EU legislation.
*4 ISO 9001: International standard for quality management systems.
*5 GMP: Standards for manufacturing and quality control of pharmaceuticals.