The three key personnel in our manufacturing and sales division (General Manufacturing and Sales Manager, Quality Assurance Manager, and Safety Management Manager) work together to establish a system that guarantees the quality and safety of all our products. In addition to the manufacturing and quality departments, the entire company, including management, is committed to quality, and our group companies also maintain a high level of quality assurance under a common quality policy.
Quality Risk Management
For pharmaceuticals, we implement quality risk management based on ICH Q9, and for medical devices, based on ISO 13485 and ISO 14971. We manage quality risks throughout the entire product lifecycle and strive to ensure product quality and stable supply by coordinating with deviation control, change control, CAPA (Corrective and Preventive Action) activities, etc.
At our group companies and manufacturing sites both domestically and internationally, we manage quality risks while taking into account the business characteristics and regulatory requirements of each site, enabling us to identify and appropriately address quality and safety issues across the entire group.
Cooperation among Group Companies
The Rohto Group regularly holds the "Rohto Group Manufacturers and Distributors Liaison Meeting" with five companies—Rohto Pharmaceutical Co., Ltd., Rohto Nitten Co., Ltd., Amato Pharmaceutical Co., Ltd., Mayado Pharmaceutical Co., Ltd., and Qualitec Pharma Co., Ltd.—with the aim of improving quality and safety at manufacturing facilities within the group. Information sharing and mutual inspections are conducted regarding factory-related matters such as manufacturing operations, records, and hygiene standards. In addition to confirming consistency with the manufacturing and marketing authorization, the companies share their best practices and challenges, and work to improve management capabilities, develop human resources, streamline operations, strengthen compliance systems, and share information on safety operations.
Globally, we hold the "Rohto Mentholatum Quality Conference," which involves five companies involved in the manufacture of eye drops Mentholatum (China) Pharmaceuticals Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam) Co., Ltd., Rohto Nitten Co., Ltd., and Rohto Pharmaceutical Co., Ltd. At this conference, we share the latest information on quality and regulations, as well as quality assurance activities, manufacturing and quality control challenges, and improvement examples from each site. By having each company and site learn from each other and leverage their respective strengths, we aim to improve the overall quality assurance level of the group.
*1 GMP (Good Manufacturing Practice) Ordinance: Standards for manufacturing control and quality control in manufacturing facilities.
*2 GQP (Good Quality Practice) Ordinance: Standards for quality control methods for pharmaceuticals, quasi-drugs, cosmetics, and Regenerative medicine products.
*3 QMS (Quality Management System) Ordinance: Standards for manufacturing control and quality control of medical devices and in vitro diagnostic medical devices.
Compliance with Guidelines
Based on the compliance guidelines issued by the Ministry of Health, Labor and Welfare, we have created the "Legal Compliance System at Rohto Pharmaceutical" and made it available to all employees. We also provide compliance training to all employees using e-learning (Rohto Academy) on the contents of the "Legal Compliance System at Rohto Pharmaceutical," deepening their understanding of the importance of legal compliance and our company's system, and establishing our company's compliance system.
Compliance