Quality Assurance System

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.

Rohto Pharmaceutical's Quality Assurance System
  • 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

With the aim of improving the quality and safety of manufacturing plants within the Rohto Group, five group companies (Rohto Pharmaceutical Co., Ltd., Rohto Nitten Co., Ltd., Amato Pharmaceutical Co., Ltd., Mayado Pharmaceutical Co., Ltd., and Qualitech Pharma Co., Ltd.) regularly hold Rohto Group Manufacturing Distributor Collaboration Meetings as a forum for information sharing and collaboration. They confirm details about manufacturing operations, records, hygiene standards, and other factory-related matters within the plants, and mutually inspect to ensure there are no discrepancies with approval documents or irregularities. They also work to improve each company's management capabilities by introducing outstanding personnel, improve efficiency through human resource development and collaboration through problem-solving, build a legal compliance system, and share information on safety operations.
Globally, the five companies that manufacture eye drops Mentholatum (China) Pharmaceuticals Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam) Co., Ltd., Ltd., and Rohto Pharmaceutical Co., Ltd. - gather to share the latest information, information from each base, and reflect on their own companies at the Rohto Mentholatum Quality Conference. Utilizing the strengths of each group company, we 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