We have an organization in which the three officers of the manufacturing
authorization (General Marketing Manager, Quality Assurance Manager, and
Safety Management Supervisor) work together to guarantee the quality of
all our products. We promote a system in which not only the manufacturing
and quality sections, but also the entire Company, including the management
team, is committed to quality and safety. The same Quality Policy applies
to our Group companies, and we have a system in place to achieve a high
level of quality assurance.
- 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
In Japan, 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 manufacturing plants. We check manufacturing operations,
records, sanitation standards, and other plant-related details to ensure
there are no discrepancies with respect to approval documents, while conducting
mutual inspections to make sure there are no irregularities. We also endeavor
to enhance the management capabilities of individual companies by introducing
outstanding human resources. Other initiatives include human resources
development by resolving issues, raising efficiency through collaboration,
establishing a compliance system, and sharing information on safety activities.
Globally, we hold a Rohto Mentholatum Quality Conference with five companies
having eye drop manufacturing sites, Mentholatum (China) Pharmaceuticals
Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam)
Co., Ltd., Rohto Nitten Co., Ltd., and Rohto Pharmaceutical Co., Ltd. At
the conference, they share information about each site and examine their
own companies, while inputting the latest information. By leveraging the
strengths of each Group company, we strive to provide products that ensure
quality and safety for people around the world.
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.
Compliance