Quality Assurance Building
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- Quality Assurance Building
In response to growing product output due to the recently increased use of generic drugs,
heightened quality requirements imposed on pharmaceutical companies,
and the need to devote efforts to passing an inspection by the U.S. Food and Drug Administration (FDA),
we strive to strengthen our quality assurance system by increasing the number of quality assurance staff members.
The building dedicated to quality assurance provides a favorable workplace environment
for an increased number of staff and helps enhance work efficiency.
Features of the Quality Assurance Building
The Quality Assurance Building has a library next to an inspection room so that staff will be able to respond quickly and effectively to requirements imposed in inspections.
In various spots around the building, there is security equipment with a surveillance camera and an entry management system using ID cards. The library is protected by a document removal management system, which manages the removal of hardcopy files of manufacturing records and testing records from the library. These systems, which raise the security level of the building, helps perform more advanced security management, including preventing information leakage or data falsification.
The reference sample*1 room is equipped with a permanent power supply device, which can supply power to freezing and refrigerating equipment even during power failures and help maintain the quality of reference samples.
The Quality Assurance Building uses wall surface gardening and solar power generation to significantly reduce energy consumption compared with an ordinary building. The building has obtained Nearly ZEB*2 certification, which recognizes it as meeting standards for an energy-saving building.
« Overview of the Quality Assurance Building »
| Location | 326 Yokamachi, Toyama City, Toyama Prefecture (on the Daito HQ factory site) |
|---|---|
| Investment amount | About 350 million yen in total |
| Building overview | Three-story steel-frame building Building area: About 464 m² Total floor area: About 1,277 m² |
| Use | Office work related to quality assurance and storage of documents and reference samples |
| Start of construction | 4/1/2021 |
| Completion | 11/30/2021 |
*1: Reference samples refer to samples stored for future analytical testing so that quality can be evaluated in the event of a deficiency in a marketed product.
* 2: “ZEB” is an abbreviation for “net-zero energy building.” The Japanese Ministry of Economy, Trade and Industry (METI) defines a ZEB as a “building that can achieve net-zero or negative annual primary energy consumption.” A Nearly ZEB is a building close to a ZEB. Being certified as a Nearly ZEB requires a building to achieve energy consumption of less than 25% of conventional buildings.
To contribute to METI’s efforts to realize net-zero energy buildings (ZEBs),
Daito applied for registration of its Quality Assurance Building
in response to an open call for “ZEB planners” issued by the Sustainable Open Innovation Initiative.
The building has been successfully registered.
Number of Regulatory Assurance staff members
As of July 2023, Daito has 205 staff members working in Regulatory Assurance. Among them, about 60 staff members mainly in the Quality Assurance Department and Regulatory Affairs work in the Quality Assurance Building.