Quality Assurance Framework Aligned with Global Standards and PIC/S Compliance
First written in FY2016. 4 of 10 entries say "Advanced", first in FY2022. Latest entry: FY2026.
1 other company's latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「Findings by regulatory authorities in each country subject to administrative action (target: 0) Product shortages and recalls attributable to product quality (target: 0) 0 in each category" "Construction is under way on a new drug product manufacturing plant compliant with globally required quality standards (scheduled to begin operations in FY2027)」
There were 0 findings by regulatory authorities relating to quality and 0 quality-related product shortages or recalls. Construction is progressing on the new drug product manufacturing plant, which is scheduled to begin operations in FY2027 and is designed to comply with quality standards. - FY2025AdvancedAnnual report
「Establishment of a global supply system for biopharmaceuticals" "Construction commenced on a new drug product manufacturing plant compliant with globally required quality standards」
The company incorporated compliance with global quality standards into the construction of the new drug product manufacturing plant, linking the expansion of its supply and quality assurance systems with facility development. - FY2024AdvancedAnnual report
「Findings by regulatory authorities in each country subject to administrative action (target: 0) Product shortages and recalls attributable to product quality (target: 0) 0 in each category」
For the global quality assurance framework, the company set targets of 0 findings subject to administrative action by regulatory authorities in each country and 0 quality-related product shortages or recalls, and disclosed FY2023 results of 0 in each category. - FY2023ReframedAnnual report
「Quantitative and Qualitative Enhancement of the Global Quality Assurance Framework」
Under the new five-year plan, the previous policy of introducing a global-standard quality system was reorganized as the quantitative and qualitative enhancement of the global quality assurance framework. The plan also emphasizes an integrated quality control framework spanning the research stage through commercial products. - FY2022AdvancedAnnual report
「In addition, last year the company changed the Quality Testing Division from the Production Headquarters to a structure integrated with the analytical method development division. Through this change, the company aims to operate efficiently and without unnecessary practical inefficiencies under a quality control framework capable of covering the entire process, from considering analytical methods in the early research stage through testing at shipment during commercial production.」
The Quality Testing Division was separated from the Production Headquarters and integrated with the analytical method development division, establishing an integrated quality control framework from the early research stage through commercial production. A new compliance training program was also launched. - FY2020RaisedAnnual report
「Top Management Priority: Quantitative and Qualitative Enhancement of the Quality Assurance Framework」
Against the backdrop of increasing development products and commercial products in the lysosomal disease field and an expanding supply chain, the company positioned the quantitative and qualitative enhancement of its quality assurance framework as its top management priority, replacing the previous policy of introducing a global-standard quality system. - FY2019RestatedAnnual report
「In addition, as the company expands its operations globally, it will introduce a pharmaceutical quality system meeting global standards and continue pursuing a higher level of safety.」
The company reaffirmed its policy of maintaining a global-standard quality system to support global expansion and improving safety. - FY2018RestatedAnnual report
「In addition, as the company expands its operations globally, it will introduce a pharmaceutical quality system meeting global standards and pursue a higher level of safety.」
The company reaffirmed its policy of introducing a global-standard pharmaceutical quality system to support global expansion and improving safety. - FY2017ReframedAnnual report
「In addition, as the company expands its operations globally, it will introduce a pharmaceutical quality system meeting global standards and pursue a higher level of safety.」
The previous wording referring to a world-class quality assurance framework and PIC/S compliance has been broadened to encompass a global-standard pharmaceutical quality system supporting global expansion. - FY2016First statedAnnual report
「As a foothold for achieving overseas expansion, the company has already established a world-class quality assurance framework and will continue promoting compliance with quality-related regulations, including PIC/S.」
The company has positioned a world-class quality assurance framework as the foundation for overseas expansion and will continue addressing regulations such as PIC/S.