Safety and Reliability
Approach and Policy
As a company involved in food and medicine, the Takara Group believes that it is important that customers find us reliable. In order to continue to be a corporate group trusted by customers into the future, we have established, and are working on, the Takara Group Quality Policy.
Takara Group Quality Policy
Based on our corporate philosophy, which is “Contributing to the creation of a vital society and a healthy lifestyle through our fermentation technology and biotechnology in a way that achieves harmony with nature,” we will bring safe and reliable products and services to customers throughout the world.
- 1.We will listen carefully to our customers and pursue quality that satisfies them.
- 2.We will work together as a group on quality assurance activities throughout the entire process until products are delivered to customers.
- 3.We will comply with the relevant laws, regulations and voluntary standards.
- 4.We will live up to the trust of our customers by making efforts to provide them with appropriate information that is easy to understand.
Targets
| Themes | Measures | Medium- to Long-Term Targets |
|---|---|---|
| Ensuring safe and reliable quality at Takara Shuzo | Maintain safety management system (FSSC22000 at six plants in Japan) |
[ Takara Shuzo ] - Maintain FSSC22000 at all six plants in
Japan. |
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Creating safe products at Takara Shuzo - Examine compliance with laws, regulations, and voluntary standards at the design stage - Stable procurement of raw materials whose safety has been confirmed - Maintain manufacturing lines that ensure safe and reliable quality |
[ Takara Shuzo ] - Ensure to check the safety quality in each of product design, raw material procurement, and production phases, thereby further enhancing the quality control system. - Conduct regular training sessions on laws and regulations relevant to product development. - Maintain a completion rate of 100% for the auditing and quality control assessment of new outsourcing contractors and raw material suppliers. - Maintain a completion rate of 100% for checking the safety of raw materials with warranties. |
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| Pursue customer satisfaction (ISO10002) |
[ Takara Shuzo ] Improve the process of handling complaints and increase the knowledge of departments handling them. a. The Quality Control Department provides training sessions at least once a year to improve the knowledge of Customer Contact Office staff members. b. Lectures on customer response and comprehension tests are carried out to improve the knowledge of sales staff.(Achieved a 100% test completion rate) |
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| Ensuring safe and reliable quality at Takara Bio Group | Maintain the quality management system (ISO9001, etc.) at Takara Bio Group |
[ Takara Bio Group ] - Maintain ISO certifications obtained by business offices and strive to increase quality and customer satisfaction. Expand the scope of areas to obtain ISO certifications where necessary. - Maintain licenses, registrations, and the like necessary for operating business. - Establish and continuously improve a quality control system and ensure a stable supply of marketed products for regenerative medicine, cell therapy, and gene therapy. |
| Comply with and maintain various quality, manufacturing, and safety standards, including GMP/GCTP (*1), and third-party certification systems | ||
| Foster a corporate culture that emphasizes quality |
[ Takara Bio Group ] - Organize the Task Force to Foster Quality Culture and use education, training, and continuous improvement to cultivate a corporate culture that emphasizes quality and a sense of responsibility. |
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| Appropriately disclose product information |
[ Takara Bio Group ] - Provide information for Takara Bio products (reagents) through SDS*2 in multiple languages (Japanese, English, Chinese). |
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| Ensuring safe and reliable quality at Takara Shuzo International Group |
Efforts toward the establishment of a global quality assurance system - Understand information on overseas food safety laws and regulations and comply with them - Promote the obtainment of certifications on food safety by overseas group companies. |
[ Takara Shuzo International Group ] - Properly carry out food regulation surveys for exported products. - Support quality improvement initiatives by conducting quality audits on overseas Group companies and taking appropriate corrective measures if any quality risk factors are found. - Verify safety through documentation reviews and conduct on-site audits as necessary when adding new suppliers. |
- *1 GMP:Good Manufacturing Practice, GCTP:Good Gene, Cellular, and Tissue based Products Manufacturing Practice
- *2 SDS:Safety Data Sheet (safety data sheets for chemical substances)
Related SDGs
Initiatives
Ensuring Safe and Reliable Quality at Takara Shuzo
Maintain Safety Management System (FSSC22000 at six plants in Japan)
We are committed to maintaining the highest standards of food safety and quality across all operations. All six plants within Japan—Matsudo, Kusu, Fushimi, Shirakabegura, Kurokabegura, and Shimabara—are certified under FSSC 22000, an internationally recognized food safety management system. This certification demonstrates our dedication to risk management, global compliance, and consumer trust.
Creating Safe Products at Takara Shuzo
Examine compliance with laws, regulations, and voluntary standards at the design stage
Our design review process covers every aspect of product development—from raw materials and packaging to manufacturing processes, labeling, and shipping—ensuring quality, safety, and regulatory alignment. To strengthen expertise, we regularly conduct training sessions for staff on key regulations, including the Liquor Business Act, Food Labeling Act, and Act against Unjustifiable Premiums and Misleading Representations. This proactive approach ensures that our products meet the highest standards of safety, functionality, and transparency.
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Stable procurement of raw materials whose safety has been confirmed
In procuring raw materials, we carefully verify the supply chain and only use materials whose quality, safety, and regulatory compliance have been confirmed through quality assurance documentation. In addition to these efforts, we conduct regular quality audits of suppliers that supply raw materials and carry out analysis of residual pesticides/herbicides, heavy metals, stable isotope ratios of alcohol imported from overseas, etc. according to the conditions of raw materials and suppliers, in order to improve the reliability of raw material quality by ensuring that any hazardous substances or foreign materials are not mixed in the raw materials.
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Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
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Recognition as Outstanding Food Hygiene Facilities by the Minister of Health, Labour and Welfare
Takara Shuzo Co., Ltd.’s Fushimi Plant (West) and Shirakabegura have been honored as Outstanding Food Hygiene Facilities in the FY2025 “Commendation for Meritorious Contributors to Food Hygiene and Outstanding Food Hygiene Facilities,” jointly organized by Japan’s Ministry of Health, Labour and Welfare and the Japan Food Hygiene Association.
This commendation aims to set exemplary standards by recognizing facilities that demonstrate exceptional food hygiene practices.
Both plants have consistently maintained FSSC 22000 certification, ensuring the proper operation of food safety and quality management systems. Their robust production management and commitment to excellence were highly evaluated, leading to this prestigious recognition. -
Commendation Ceremony
Pursue Customer Satisfaction (ISO10002)
In fiscal 2025, the Customer Contact Office received 6,784 comments. These include a wide variety of inquiries, feedback, and findings about products, and Takara Shuzo listens carefully to each of these comments, striving to deliver products and improve services in order to satisfy customers. In addition, videos on frequently asked questions are posted on the website of the Customer Contact Office, and efforts are being made to make them easier for customers to understand. We have made a declaration of conformity to ISO 10002 (targeting management systems for handling customer requests and complaints) and thus clarified our specific efforts and responsibilities to improve customer response, thereby continually Maintenance of the Food Safety Management striving to improve these processes.
Ensuring Safe and Reliable Quality at Takara Shuzo International Group
Ensuring the Safe Export of Products
Takara Shuozo gathers and monitors information on food-related laws, regulations, and regulatory developments in countries around the world to ensure compliance with the import requirements of each export destination. We also take proactive measures to prepare for future regulatory changes and revisions. Furthermore, we work closely with relevant departments to promptly respond to inquiries, verification requests, and investigations from our overseas group companies. Through these efforts, we strive to ensure that our products are delivered safely and reliably to customers worldwide.
Ensuring Safe and Reliable Quality at Takara Bio Group
Maintain Quality Management System (ISO9001, etc.)
In the Takara Bio Group, Takara Bio Inc., Takara Biotechnology (Dalian) Co., Ltd., DSS Takara Bio India Pvt. Ltd., and Takara Bio Europe S.A.S have obtained the ISO 9001 certification for quality management systems. On top of this, Takara Bio USA, Inc. and Takara Biotechnology (Dalian) Co., Ltd. have obtained the ISO 13485 certification for diagnostic agent quality management systems and engage in strict quality control.
Comply with and Maintain Various Quality, Manufacturing, and Safety Standards, Including GMP/GCTP, and Third-party Certification Systems
Takara Bio’s Gene and Cell Processing Center provides contract manufacturing and quality testing services in compliance with GMP/GCTP (Good Manufacturing Practices and Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) requirements. We has also obtained the necessary licenses and registrations, including registration as a hygiene testing laboratory, a license for the manufacture of specified cell-processed products, and a license for the manufacture of regenerative medicine products. In the gene analysis and inspection business, we have been taking measures such as acquiring certifications from third-parties such as a recognition from the College of American Pathologists: Laboratory Accreditation Program (CAP-LAP).
Appropriate Disclosure of Product Information
We actively publish materials related to product safety. We disclose and provide appropriate information in accordance with laws and regulations in various languages, including product manuals, Certificate of Analysis (CoA), SDS (Safety Data Sheet), the indication of poisonous or deleterious substances in accordance with the Poisonous and Deleterious Substances Control Act, and the labeling of products that fall under living modified organism (LMO) based on the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (the Cartagena Act).