Fuji Pharma's Commitment to Quality
Based on the corporate philosophy of "We help people lead healthy lives by offering excellent pharmaceuticals", Fuji Pharma has established a quality policy and a reliability assurance system to supply pharmaceuticals that patients and healthcare professionals can use safely and with confidence.
This page introduces the content of this policy and our efforts.
Quality Policy
See the following page for details of our quality policy.
Quality PolicyReliability Assurance System
In the Act Partially Amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and Other Acts (Act No. 63 of 2019, hereinafter referred to as the "Amended Pharmaceuticals and Medical Devices Act"), provisions concerning the system for legal compliance of licensed business operators were established.
Fuji Pharma has established the following reliability assurance system to strengthen its governance system through compliance with laws and regulations, and is striving to further ensure quality, efficacy, and safety and to ensure stable supply by strengthening cooperation with manufacturing and marketing systems.
Officers, etc. responsible for operations related to pharmaceutical affairs
Based on the purpose of the Amended Pharmaceuticals and Medical Devices Act, the officers responsible for pharmaceutical affairs (responsible officers) have been clarified. In addition, based on the provisions of the Act, we have established a three-role system in the manufacturing and marketing business consisting of three roles by designating the General Marketing Authorization Officer and Marketing, Quality Assurance Manager, and Safety Control Manager.
Under the responsibility and management of the responsible officers, the following persons (all executive officers) are assigned to each duty.
General Manager of Quality Assurance Department: Pharmaceutical affairs, quality assurance, safety control
General Manager of Sales Division: Sales, advertising
General Manager of Corporate Business Management Department: Legal compliance
| Manager | Name | Title |
|---|---|---|
| Pharmaceutical General Manager of Manufacturing and Marketing | Yukihisa Sato (Pharmacist) | Manager of the Regulatory Compliance Division |
| Quality Assurance Manager | Mitsuo Mizuguchi | Manager of the Quality Assurance Department, Regulatory Compliance Division |
| Safety Control Manager | Nao Takigawa (Pharmacist) | Group Manager of the Drug Safety Management Group, Drug Safety Management Department, Regulatory Compliance Division |
Three-role system in manufacturing and marketing business
Declaration of legal compliance
In line with our quality policy, we will put into practice our corporate philosophy of "We help people lead healthy lives by offering excellent pharmaceuticals" and declare our highest priority of complying with laws and regulations.
Internal audit system
We will develop and implement risk-based audit plans to maintain our legal compliance system.
We will maintain a system in which the General Manager of Manufacturing and Marketing, manufacturing managers, etc., who are most closely involved in issues and problems for compliance with laws and regulations related to manufacturing control, quality control, and safety control after manufacturing and marketing of pharmaceuticals, etc., provide appropriate opinions to the responsible officers.
Strengthening the manufacturing and marketing system
We are promoting the establishment of an appropriate audit system for manufacturing facilities through a three-role system in manufacturing and marketing business consisting of three roles of the General Manager of Manufacturing and Marketing, Quality Assurance Manager, and Safety Control Manager, and a three-line risk management system consisting of the Operational Division, Indirect Control Division, and Internal Audit Division.
Three-line risk management system
Implementation Status of Inspections Regarding Consistency Between Manufacturing and Marketing Approvals for Generic Drugs and Actual Conditions
Based on the "Implementation of Inspection Regarding Consistency Between Manufacturing and Marketing Approvals and Manufacturing and Testing Methods for Generic Drugs" (HPIIP Notification No. 0405-1, PSB/PED Notification No. 0405-8, PFSB/CND Notification No. 0405-1 dated April 5, 2024), we conducted inspections (including interviews) to verify the consistency between the manufacturing and marketing approvals and manufacturing and test methods. The inspection results were reported to the Health and Welfare Department, Toyama Prefecture on October 31, 2024.
