Responsible Officers
- Top
- Businesses
- Quality Assurance
- Responsible Officers
Management Members’ Supervision of Product Quality
To comply with the revised Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, which came into effect in August 2021, Daito has created a Quality Manual under the supervision of three directors who serve as “responsible officers” and begun to use the manual strictly. The responsibilities of responsible officers include fostering appropriate collaboration between different units in increasing product quality and providing sufficient and appropriate management resources (staff, materials, equipment, devices, environments, etc.) for quality assurance. The responsible officers offer necessary instructions and support to related departments through the monthly quality management review.*
* Meeting where staff report quality-related issues and challenges to management members, including top management
System for Keeping in Contact with Client Companies
We have established a system whereby the Quality Assurance Unit can report to management in order to ensure that prompt responses will be taken in the event of product recalls or other cases. We have also formulated rules on a system for communication with external client companies that sell our products in preparation for a prompt response to an emergency.
(1) Responsible officers
To clarify the persons who are responsible for legal compliance and the establishment of systems for legal compliance, a marketing authorization holder shall legally position officers who are responsible for regulatory duties (responsible officers) and report their names on application forms for licenses.
(2) Systems for legal compliance
A marketing authorization holder shall establish systems for legal compliance, including systems for identifying problems in legal compliance and implementing measures to solve the problems.
(3) Obligation to appoint a responsible person
To conduct its business appropriately in compliance with laws and ordinances, a marketing authorization holder shall select a supervisor of manufacture and sale and a manufacture manager who have necessary capabilities and experience.
Responsible officers under the revised Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
薬事業務の責任役員及び業務分掌 (2025年1月現在)
| Research and Development | Regulatory Affairs | Quality Assurance (GQP) |
Safety Management (GVP) |
Manufacturing Management (GMP) |
Compliance | Advertisement | Pharmaceutical Sales | ||
|---|---|---|---|---|---|---|---|---|---|
| Chairperson | Yasunobu Otsuga | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ |
| President and CEO | Hiroshi Matsumori | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ |
| Board Director and Senior Corporate Officer | Kazushige Hizume | ○ | ○ | ○ | |||||
| Board Director and Corporate Officer | Toru Ishida | ○ | ○ | ○ | ○ | ○ | ○ |