The three key roles in the manufacturing and sales business (general manufacturing and sales manager, quality assurance manager, and safety management manager) work together to create an organization that guarantees the quality of all our products. We are promoting a system in which the entire company, including not only the manufacturing and quality departments but also the management team, is committed to quality and safety. We have also established a system that can achieve high quality assurance under the same quality policy for group companies.
- All quality-related activities at Rohto Pharmaceutical comply with laws and regulations, including the Pharmaceuticals and Medical Devices Act, GMP Ministerial Ordinance *1, GQP Ministerial Ordinance *2, QMS Ministerial Ordinance, etc. *3.
Furthermore, our quality improvement activities are not limited to the framework of Rohto Pharmaceutical, but we aim to reach even greater heights by collaborating with group companies.
*1 GMP (Good Manufacturing Practice) Ministerial Ordinance: Standards for manufacturing management and quality control at manufacturing sites
*2 GQP (Good Quality Practice) Ministerial Ordinance: Standards that stipulate methods for quality control of pharmaceuticals, quasi-drugs, cosmetics, and Regenerative medicine products.
*3 QMS (Quality Management System) Ministerial Ordinance: Ministerial Ordinance on Manufacturing Management and Quality Control of Medical Devices and In-Vitro Diagnostic Reagents
Cooperation among Group Companies
To improve the quality and safety levels of manufacturing plants within the Rohto Group, the five group companies (Rohto Pharmaceutical Co., Ltd., Rohto Nitten Co., Ltd., Amato Pharmaceutical Co., Ltd., Mayado Pharmaceutical Co., Ltd., and Qualitec Pharma Co., Ltd.) regularly hold the Rohto Group Manufacturing and Sales Partnership Meeting as a forum for information sharing and collaboration. Participants review factory-related matters such as manufacturing operations, records, and hygiene standards, mutually check for discrepancies with approval documents and the absence of fraud, improve management capabilities of each company through the introduction of outstanding personnel, develop human resources through problem-solving and efficiency improvements through collaboration, build compliance systems, and share information on safety operations.
Globally, five companies involved in the manufacture of eye drops Mentholatum (China) Pharmaceuticals Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam) Co., Ltd., Ltd., and Rohto Pharmaceutical Co., Ltd.—gather to hold the Rohto Mentholatum Quality Conference, where they share information from each location, gather the latest information, and reflect on their own operations. By leveraging the strengths of each group company, they strive to provide products that ensure quality and safety to people all over the world.
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