Quality Assurance System

Quality Assurance System
  • We believe that quality is not produced solely by the plant, but that it is the first product of high quality to be produced by all departments of ROHTO Pharmaceutical, including the design department, to work seriously toward quality.
  • ROHTO Pharmaceutical has established a system (mechanism) for quality initiatives that includes the president as well as manufacturing and quality departments, and is working to improve the quality of products throughout ROHTO Pharmaceutical.
  • All activities of Toro Pharmaceuticals with respect to quality are in compliance with the Pharmaceuticals and Medical Devices Law, GMP ordinance*1, GQP ordinance*2, QMS ordinance, etc.*3, and legal regulations.
    In addition, activities to improve quality are not limited to ROHTO Pharmaceutical, but are aimed at further enhancement by cooperating with Group companies.

*1 GMP(Good Manufacturing Practice) Ministerial ordinance: Standards for Manufacturing Control and Quality Control at Manufacturing Sites
*2 GQP (Good Quality Practice) Ministerial ordinance: Standards for Quality Control of Drugs, Quasi-drugs, Cosmetics, and Regenerative Medicine Products
*3 QMS(Quality Management System) Ministerial ordinance: Ministerial ordinance for manufacturing control and quality control of medical devices and in vitro diagnostic reagents

Cooperation among Group Companies

The Rohto Group Marketing Authorization Holder Joint Meeting is regularly held as a forum for information sharing and discussion among five Group companies (Rohto Pharmaceutical Co., Ltd., Rohto Nitten Co., Ltd., Amato Pharmaceutical Products, Ltd., Mayado Pharmaceutical Co., Ltd., and Qualitech Pharma Co., Ltd.) with the aim of enhancing the quality and safety of the Group’s domestic manufacturing plants and building a platform for such enhancement. In addition, we check manufacturing operations, records, sanitation standards, and other plant-related details to ensure that there are no discrepancies with approval documents, while conducting mutual inspections to make sure that there are no irregularities. We also endeavor to enhance the management capabilities and solve the issues of individual companies by introducing outstanding human resources. These initiatives are aimed at raising efficiency through human resource development and collaboration, creating a compliance system, and sharing information on safety activities. Our Group companies are composed of various predecessors, each of which has a quality system that has been cultivated over many years. Building on the strengths of individual companies, the entire Group works together to provide even higher quality products.

Compliance with Guidelines

Based on the legal compliance guidelines issued by the Ministry of Health, Labour and Welfare, we have created and disclosed to all employees the "ROHTO Pharmaceutical's Legal Compliance System." In addition, we have conducted compliance training for all employees using e-learning (ROHTO Academy) regarding the content of the "Legal Compliance System at ROHTO Pharmaceutical Co., Ltd." to deepen their understanding of the importance of legal compliance and our system, and have established our compliance system.