To ensure that our customers can use our products and services safely, we have established a basic policy on quality assurance and work to ensure safety in compliance with that policy.

Takara Bio Group Quality Assurance Policy

1.Basic Policy on Quality Assurance

  • The Takara Bio Group provides high quality products and services that fulfill the trust and expectations of customers.
  • The Takara Bio Group delivers products and services that are safe and that customers feel sure of.
  • The Takara Bio Group complies with laws and regulations.
  • The Takara Bio Group ensures the dissemination of this basic policy to each and every officer and employee in the Group and makes its execution certain.

2.Quality Assurance System

  • The Quality Assurance Management Committee is based at the Head Office to ensure the reliability and effectiveness of the company-wide quality assurance system.
  • The committee, chaired by the company’s President, determines the company-wide guidelines regarding quality with attendance of Supervisor from Corporate Management Unit, President of each Business Unit, Subsidiaries in charge of Bioindustry Business Unit and Board Member in charge of General Affairs Department.
  • Each business division has its own Quality Assurance Committee and ensures the compliance of each business division with the Basic Policy on Quality Assurance.
  • Compliance with the Basic Policy on Quality Assurance is also ensured at the Company’s subsidiaries, and subsidiaries establish a quality assurance system that is equivalent to the one at the Company.
  • The Quality Assurance Committees assess the status of establishment and operation of the quality assurance system in each business division and provide appropriate guidance and supervision.

Quality control efforts

Takara Bio and all its major global subsidiaries have acquired ISO certification, and are striving to improve the quality of products and services. We built a GMP/GCTP* compliant quality control system at our Center for Gene and Cell Processing, which provides CDMO services, and have become licensed as a manufacturer/distributor of specific processed cells/regenerative medicine products, pharmaceutical products (drugs, etc.), and in vitro diagnostics. Our lab for gene analysis services and genetic testing is also CAP-LAP certified and licensed as a clinical laboratory.

 

We will strive to maintain these certifications and licenses, as well as expand the scope of certification as needed. 
 

※GMP: Standard for manufacturing control and quality control for pharmaceutical products 

 GCTP: Standard for manufacturing control and quality control for regenerative medicine products

We will continue implementing rigorous quality controls across all products and services, from reagents to CDMO services

Masanobu Kimura, Director 

 

Takara Bio supports the advancement of the global bioindustry by providing a wide range of products and services, from in vitro diagnostics and other reagents to CDMO services for regenerative medicine products. To maintain and improve the quality of these products and services, we work to acquire and maintain relevant certifications, such as ISO certification and GMP/GCTP compliance, and are building a quality assurance system across the entire company.

 

We are also working to build systems for collection, control, and management of safety data for ongoing clinical development projects in the gene therapy field to ensure the regulatory application process goes smoothly.

As of December 2021

Consolidated Subsidiaries
(Location)
Applicable Standards, Certifications
Takara Bio Inc. (Japan) JIS Q 9001:2015 (ISO 9001:2015) *1
JIS Q 13485:2018 (ISO 13485:2016) *2
CAP-LAP
Clinical Laboratory Registration
Certification from the Health Science Center for Accreditation of Laboratory Animal Care and Use 
Authorization of manufacturing cell processing products in Japan. 
Authorization of manufacturing of regenerative medicine products
Authorization of manufacturing and distribution of regenerative medicinal products 
Authorization of manufacturing of biologics  
Registration for manufacturing f in-vitro diagnostics 
Authorization of manufacturing and distribution of in-vitro diagnostics 
Registration certificate of foreign in-vitro diagnostic manufacturer 
Certificate of conformance to QMS 
Authorization of manufacturing and distribution of in-vitro diagnostic 
Authorization of distribution of pharmaceutical products (wholesaler) 
Takara Bio USA, Inc. (U.S.A.) ISO 13485:2016
Takara Bio Europe S.A.S (France) ISO 9001:2015
Takara Bio Europe AB (Sweden) -
Takara Biotechnology (Dalian)Co., Ltd. (China) ISO 9001:2015
ISO 13485:2016
(EN ISO 13485:2016)
DSS Takara Bio India Private Limited (India) ISO 9001:2015

*1 Scope of the registration
Design, development, manufacture, and sale of research reagents, cell culture media, and scientific instruments

Design, development, manufacturing, and sales of pharmaceutical raw materials

Design, development, and provision of gene engineering / cell engineering research support services and genetic testing support services

Design, development, and provision of contract manufacturing, quality testing, inspection, and storage services for products such as regenerative medicine products, investigational products, and cell processing products

Design, development, manufacturing, and sales of raw materials for in-vitro diagnostic Design, development, manufacturing, and sales of in-vitro diagnostic

 

* 2 Scope of registration
Design, development, manufacture, and sale of reagents for molecular biology used as raw materials for in-vitro diagnostic 

Design, development, manufacturing, and sales of in-vitro diagnostic (virus test kits)

Appropriate publication of product information

We actively work to publish documents related to product safety. We publish and provide information as appropriate in multiple languages in accordance with laws and regulations, including user manuals, CoA (Certificate of Analysis), SDS (chemical Safety Data Sheet), poisonous and deleterious substance labeling in accordance with the Poisonous and Deleterious Substances Control Law, and LMO (living modified organism) product labeling in accordance with the Cartagena Protocol.

Takara Bio Group Sustainability Plan

Theme Measure Targets
Ensure product safety Maintain quality management system certifications
(ISO9001, etc.)
•Maintain current ISO certifications at plants and work to improve quality and customer satisfaction.
Expand scope of ISO certification as necessary.
• Maintain business licenses and registrations.
Achieve and maintain compliance with relevant quality,
manufacturing, and safety standards such as GMP/
GCTP, and third-party certification
Appropriately disclose product information Provide information about our products in multiple languages (Japanese, English, and Chinese) through Safety
Data Sheets (SDS) by 2025.

※1 GMP:Good Manufacturing Practice、 GCTP:Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
※2 SDS: Safety Data Sheet