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Quality

Otsuka’s approach to product quality extends beyond safety and security in manufacturing. Striving also to enhance the quality of its social initiatives, the group is focused on a broad range of activities, from information transparency and disclosure to working with suppliers and other collaborators, respecting local communities, and ensuring compliance with regulations.

Safety Initiatives

As the duty of a company that is committed to the betterment of life, the Otsuka group thinks first of the customers and patients who use its products. We pursue business activities that place the highest priority on the quality and safety of our products.

Quality and Safety Control

The Otsuka group, placing its ultimate priority on customers and patients as a healthcare company, has established rigorous quality control systems suited to the characteristics of each of its businesses, including pharmaceuticals, cosmetics, and foods, in pursuit of product quality and safety. The Otsuka group’s quality and safety control systems comply with regulatory requirements, government and industry standards, including Japan’s Pharmaceuticals, Medical Devices and Other Therapeutic Products Act as well as Japan’s Food Sanitation Act. The group is also promoting the acquisition of international certifications such as ISO 9001 for quality, ISO 13485 for medical devices, and ISO 22000 for food safety. Furthermore, in order to ensure thorough quality control, it has adopted traceability systems covering all processes, from raw material procurement to production, distribution, and sales. Meanwhile, its major operating companies conducting global business have established global quality assurance systems. Thai Otsuka Pharmaceutical (TOP) received Thai FDA Quality Award in recognition of high-quality standard in its foods division. This is the second award TOP received, since the prize-winning of its pharmaceutical division in 2015. This award was given to the companies selected based on a comprehensive evaluation on various factors, including the circumstance of compliance with various standards such as GMP and ISO, labor-related situation, existence or non-existence of call center and innovative products, and CSR implementation status, in addition to factory inspections conducted by examiners.
 

Quality Control in the Otsuka Group

Otsuka group, Taiho Pharmaceutical

Global Quality Assurance System for IV Solutions

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In research and development of pharmaceuticals, we endeavor to improve reliability through adhering to the required regulations on nonclinical and clinical testing, demonstration of securing efficacy and safety of candidate substances for pharmaceuticals, and appropriate data management, In the manufacturing process, we aim to maintain high quality of our products or further improve the quality to higher level through establishment and operation of good manufacturing practice (GMP) systems. Furthermore, in the process of manufacturing through selling, we conduct quality control and post-marketing safety management based on good quality practice (GQP) and good vigilance practice (GVP), and prepare and revise various reports and documents submitted to regulatory authorities. We also continue to implement pharmacovigilance (PV) activities in order to collect and evaluate the safety information of products on a constant basis, and promptly provide the results to medical institutions and suppliers.
Currently, there is a global movement to set up more rigorous standards for the safety and quality of pharmaceuticals, and even higher level of quality control is required for intravenous solutions which are administered directly into body. As a leading manufacturer of IV solutions, Otsuka Pharmaceutical Factory technically cooperates with and manages the 15 Otsuka companies (in 10 countries) involved in the IV solutions business outside Japan. In this leading role, the company has voluntarily developed and implemented a strict global quality assurance system. In addition to sharing safety information and ensuring compliance with laws, regulations and industry standards in each country in which the group operates, the company works with other group companies to continuously maintain and improve product quality and develop a shared philosophy regarding quality assurance.
Otsuka Pharmaceutical Factory

Research and development activities

R&D themes
The Otsuka group provides total support for people’s health in terms of both treatment of diseases and maintenance/improvement of health. In order to address unmet medical needs, our pharmaceutical business engages in R&D under the theme of tackling unmet areas of treatment for which effective treatment options are not available, with a focus on psychiatry and neurology, and oncology. To meet yet-to-be-imagined needs, our nutraceutical business, which supports the maintenance and improvement of health, conducts R&D into original products grounded in scientific evidence, under the theme of expanding healthy life expectancy.

Ethical considerations concerning appropriate R&D
The use of experimental animals to verify efficacy and safety in R&D is at times necessary. The Otsuka group complies with all related laws, ordinances, and guidelines while striving to uphold scientifically valid methodologies and ethical considerations from the viewpoints of animal protection and welfare, including the lives of the animals; preservation of the environment; and the safety of experimenters.
As an in-house management system, we have developed and implemented rules on experiments that involve animals, have established an Animal Experiment Committee, and properly carry out animal experiments and breeding. The Animal Experiment Committee evaluates whether each proposed animal experiment plan is appropriate based on the 3Rs principles. These are Replacement/avoidance or replacement of animal use, Reduction/minimization in the number of animals used, and Refinement/minimization of animal suffering. Based on these, we conduct researcher education and internal inspections and evaluations of the implementation of experiments involving animals.

Ethical considerations in research using human-derived specimens
When conducting research using information or specimen collected from the human body, such as tissues and blood, the Otsuka group complies with all laws and guidelines and conducts scientifically and medically appropriate research with consideration of ethics. Each group company establishes committees that include outside members to ensure the appropriateness and credibility of research. The committees do so by examining research plans, the significance and goals of research, personal information management system, research progress status, and research outcomes from the standpoints of ethical and scientific validity and of protection of personal information.

Considerations in research using pathogenic microorganisms/genetically modified organisms
In experiments using genetically modified organisms, and in the use of pathogenic microorganisms or research samples that may contain these, the Otsuka group complies with laws and ordinances, and works toward the prevention of experiment-related accidents and toward consideration of the environment. We do so through the setting of internal rules and through examination by safety committees and screening committees.

Ethics in development
In the development of pharmaceuticals, we confirm the safety and effectiveness of candidate compounds by conducting clinical trials with the cooperation of healthy individuals and patients. Recognizing the importance of ethical considerations toward human rights and personal information, the Otsuka group implements clinical trials in compliance with ethical principles and standards, including ICH-GCP, an international standard for the implementation of clinical trials for pharmaceutical products.

BCP and BCM Establishment

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Otsuka Pharmaceutical Factory: Full-circumference seawall installed at Matsushige Factory

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Otsuka Pharmaceutical Factory: Emergency LED lights along evacuation routes and at evacuation sites automatically turn on during a power outage.

The Otsuka group has business continuity plans (BCP) in place to ensure that the group continues to operate as effectively as possible and is able to maintain a stable supply of its products, even when large-scale earthquakes and disasters strike.
From the perspective of business continuity management (BCM), Otsuka Holdings and Otsuka group companies have jointly developed a system to implement group-wide efforts for business continuity. In August 2012, Otsuka Pharmaceutical acquired ISO 22301 certification for “The Manufacture and Stable Supply of Products for Medical Related Business”. Since then, the Otsuka group companies have incrementally expanded the scope of its application and acquired certification for “The Stable Supply of Intravenous Solutions” in 2015 and “The Stable Supply of Anticancer Drugs” in 2016. Acquisition of ISO 22301 certification verifies that the organization has infallible business continuity capabilities from the perspective of BCM. Companies such as Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, and Otsuka Warehouse collaborate to strengthen measures and systems in order to ensure that the entire Otsuka group can continue business activities as much as possible and provide a stable supply of products even in the event of a disaster. In 2017, major Otsuka group companies conducted joint desktop exercises simulating a Tokyo Inland Earthquake to test the group’s collaborative structure for ensuring a stable supply of products under simulated conditions, and the results were extremely close to projected scenarios.
As a manufacturer of the IV solutions that would be especially required for initial treatment when an emergency situation occurs, Otsuka Pharmaceutical Factory has designated business continuity management (BCM) as a key management strategy. The company has enacted basic BCM rules and implements a variety of measures to preempt risk factors and limit damage should an unavoidable crisis occur. Otsuka Pharmaceutical Factory does not focus exclusively on its own BCM. The measures the company implements encompass the entire group to forge a united front on risk management. The company works with companies in the Otsuka group that distribute and sell its products, holding regular BCP meetings to address risks associated with Otsuka Pharmaceutical Factory business activities.
Taiho Pharmaceutical develops BCP for its production, supply chain, and IT. For production, the company identifies risk items and disperses and stores inventories of the required number of such items. It also takes measures to keep production equipment in place and prevent flooding. For supply chain, the company takes measures to ensure that the receipt of product orders, delivery requests, and other tasks can be resumed within a defined timeframe after a disaster strikes. For IT, the company has established a backup plan for critical systems, such as backbone system (accounting, HR, receipt and placement of orders) and e-mail. Furthermore, the company reports the status of such BCP measures and training to the Crisis Management Committee chaired by the president in an effort to strengthen measures and systems to ensure a stable supply of products.       
Otsuka Chemical has formed a BCM Committee consisting of directors of the production, sales, quality assurance, materials, and administration divisions that meets once every three months. It reviews progress on BCP compliance and reports to the Crisis Management Committee, chaired by the president, on its activities and upcoming fiscal year plans. Based on the latest damage and injury projections for Tokushima in the event of a potential severe earthquake in the Nankai Trough, the company’s BCP formulated in 2011 is revised as appropriate to make the BCP easier to see and understand during earthquake disasters. In addition, the company has not only participated in the BCP simulation held by the Otsuka group but also conducted a drill with an outside instructor, as part of its efforts to raise employees’ knowledge and awareness of disaster management.
With firsthand experience of the Great East Japan Earthquake in 2011, EN Otsuka Pharmaceutical has enacted basic BCM rules and a BCP to ensure a continuous stable supply of pharmaceuticals. In fiscal 2017, the company restocked the stockpiles at its locations in Hanamaki, Kitakami, and Tokyo.  
Otsuka Techno, as part of its crisis management plans (BCP/BCM) in preparation of a severe earthquake along the Nankai Trough, abnormal weather and other disasters, distributes emergency water and food supplies as well as evacuation equipment at its offices and plants in order to assist employees during emergencies. In 2017, the company set up earthquake early warning systems and plant broadcasting equipment at its head office and some plants to be utilized for the swift evacuation of employees during emergencies.  
Otsuka Electronics maintains stockpiles of emergency supplies at all of its business locations for employees who are unable to return home. These supplies are checked and restocked every year as needed.
Otsuka group, Otsuka Holdings, Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, Otsuka Warehouse, EN Otsuka Pharmaceutical, Otsuka Chemical, Otsuka Electronics, Otsuka Techno

Initiatives with Business Partners (Suppliers) and CSR Procurement 

In order to seek the sustainable development of the group and society, the Otsuka group believes that collaboration with business partners is important. We conduct safe, reliable business activities with consideration of society, in compliance with laws throughout the value chain. When beginning dealings with a business partner, we perform investigations and checks to ensure the quality of raw materials and establish stable procurement, and conclude basic trade agreements in advance to avoid risks. We also aim for mutual sustainable development through fair, equitable, and transparent procurement and building sound relationships, and are formulating group-wide procurement policies. We share these policies with business partners and are currently working to formulate procurement guidelines.
In addition, we conduct and evaluate questionnaires concerning the CSR activities of business partners, and work to further promote CSR procurement by going beyond legal compliance to assess business partners’ status with respect to human rights, labor, environment, anti-corruption measures, and more.
In order to ensure a stable supply of safe, quality products, each group company works with its suppliers to maintain and improve product quality, regularly monitoring the companies that supply raw materials to the Otsuka group. These companies are careful to maintain good business relations by communicating and sharing information on a daily basis.
EN Otsuka Pharmaceutical collaborates with suppliers to promote, to the extent possible, green procurement of raw materials and packaging materials for pharmaceuticals. The company conserves energy and reduces CO2 emissions by reusing the boxes in which raw materials are shipped, using lighter packaging materials and making packaging smaller, and promoting efficiency in truck shipments.
Otsuka Electronics, a company that manufactures and markets electronic devices globally, maintains product quality to prevent defects. When purchasing parts, the company signs a basic trade agreement and evaluates the subcontractor (reviews capacity and conducts other surveys) in advance. After the subcontractor is approved, quality is fully verified via spec sheets, approval diagrams and prototypes. The company procures and manufactures products compliant with EU standards (RoHS and WEEE directives, etc.) according to the regulations in place in the area to which they are exported.
Otsuka Pharmaceutical Factory informs its environmental initiatives to the suppliers from which it purchases materials and asks them to offer ideas on and provide environmentally-friendly products.
Nutrition & Santé SAS, a health and nutrition food product company in France, strives to procure environmentally-friendly raw materials. It has always utilized non-genetically modified organic soybeans and flour produced by sustainable farming. The company constantly seeks to form new partnerships with sustainable suppliers. In 2017, the company decided that the cocoa beans used to make biscuits and bar products would be supplied from a partner engaged in sustainable cocoa cultivation.    
Otsuka group, Otsuka Pharmaceutical Factory, EN Otsuka Pharmaceutical, Otsuka Electronics

Basic policy on measures against counterfeit drugs

Counterfeit pharmaceutical products* are products that do not contain the indicated ingredients, contain active ingredients other than those indicated, or otherwise present false labeling of identity or origin. In recent years, harm to health due to the spread of counterfeit pharmaceuticals has become a global issue. The Otsuka group has launched a global product security (GPS) team to ensure that pharmaceutical products reach patients through appropriate distribution channels that allow the assurance of quality, we are monitoring markets and are working in partnership with industry and government to ensure the safety of patients.

* Any pharmaceutical product that deceptively represents its authenticity or origin, such as drugs that do not contain the ingredients shown on the label or those that contain active ingredients other than those shown on the label.
Otsuka group

Listening to Customers

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Otsuka Pharmaceutical Factory: IV Drug Information (DI) Center

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Taiho Pharmaceutical: Tiovita Drink packaging designed to prevent cuts

In order to field and respond to customer inquiries appropriately, the Otsuka group operates departments that are organized along product lines. At Otsuka Pharmaceutical, the Drug Information Center fields inquiries about pharmaceuticals; the Customer Relation Desk in the Planning and Reliability Promotion Office fields inquiries about OTC products, quasi drugs, and cosmetics; and the Customer Relations Office responds to inquiries about functional foods and beverages. The company has also established the Telephone Service Center to respond to all inquiries made after office hours and on holidays and weekends, which often involve a level of urgency.
The IV Drug Information (DI) Center of Otsuka Pharmaceutical Factory prepares and posts up frequently asked questions and answers on its website and provides information at the pharmaceutical associations, while responding to various inquiries on pharmaceuticals and medical devices from patients and healthcare personnel. The professionals at the Customer Relations Center of OS-1 Division respond to the inquiries about medical foods, listen carefully to customers, and do their best to answer questions conscientiously, politely and in a manner that is easily understood.
At Taiho Pharmaceutical, the Pharmaceutical Information Section fields inquiries about prescription drugs, and the Customer Relations Office fields inquiries about healthcare products via telephone or e-mails. The company has also established the Telephone Service Center to respond to all inquiries made after office hours and on holidays and weekends, which often involve a level of urgency. Taiho Pharmaceutical incorporates customer feedbacks in making improvements in a variety of its products. For example, the company has adopted new specifications to reduce paper cuts for the 10-bottle inner cases and 50-bottle exterior cardboard packaging for its Tiovita Drink series since 2015. The company has realized to produce customer-friendly products by adding tiny waves to the paper to reduce the sharpness and to avoid unexpected paper cuts from the box edges.
Otsuka Chemical implements customer satisfaction surveys to collect frank opinions of customers, aiming to provide a variety of solutions leveraging the strengths of its original materials.
EN Otsuka Pharmaceutical has established a call center for iEat series of eating recovery assisting foods. The call center fields inquiries via telephone and e-mails, and takes orders for its official mail-order services. It also collects direct opinions and voices of customers on the company’s products and incorporates the feedbacks in the development of new menu and provision of exclusive products.
 
Otsuka group, Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, Otsuka Chemical

Information Security Initiatives

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Otsuka Pharmaceutical: PrivacyMark

The Otsuka group has formed the Otsuka group Information Security Committee for the purpose of sharing the latest information on information security and reviewing specific security measures. Otsuka focuses on boosting the level of comprehensive security throughout the entire group and continuously improving the information security process.
In order to counter the risk of cyber-attack, the Otsuka group has a number of measures, such as inspecting security of systems, diagnosing website vulnerabilities, conducting drills related to targeted email attacks, and monitoring the content of social media messages, with outside security companies. In addition, the group conducts regular emergency drills focusing on systems that are vital to database management.
The Otsuka group has established a privacy protection management system to protect customers’ valuable personal information and has acquired PrivacyMark certification and Information Security Management System (ISMS) certification in businesses where this certification is relevant.

Group Companies Its Initiatives

Otsuka Pharmaceutical
Otsuka Pharmaceutical has formed the company-wide Information Security Committee for the purpose of sharing the latest information on information security and reviewing specific security measures. The company aims to enhance the level of comprehensive security for all employees and continuously improve the information security process. In order to counter the risk of cyber-attacks, the company conducts drills against targeted email attacks, and monitors the content of social media messages. Furthermore, the company keeps close tabs on the inappropriate usage of information devices by obtaining a log in order to prevent any form of information leakage from occurring. The company has also established a personal information protection management system and obtained the PrivacyMark certification for the purpose of protecting customers’ valuable personal information.

Otsuka Pharmaceutical Factory
Otsuka Pharmaceutical Factory implements trainings related to information security to all newcomers, regardless of new graduate or mid-career, in a nod to the importance of information security. The company also implements IT education such as Microsoft Office trainings for those who are interested in the improvement of information technology literacy, as well as periodic education to the employees in charge of information security in each department. As for the management of information assets, the company regularly reviews document administration books and personal information management books, carries out the counting of the inventories such as PC and USB memories, and confirms the observance status of information security for the relevant data and devices.

Taiho Pharmaceutical
Taiho Pharmaceutical understands the importance of security, and takes information security, personal information protection, and document administration as a unit. To this end, the company has established the Information Asset Management Committee, which maintains and promotes the management of information assets. The Committee works on the initiatives for the visualization of the management status and improvements in each department in cooperation with the department head and the personnel in charge of promoting information asset management. The ongoing initiatives include, for example, the implementation of e-learnings and confirmation of consent on the handling of information assets (once a year), and the confirmation of information devices by the user employee and his/her superior, as well as the quarterly implementation of questionnaire regarding the usage status of information devices.

Otsuka Foods
Otsuka Foods has shared the information on information security and personal information protection at the Otsuka Group Information Security Committee, and implemented the drills against targeted email attacks and information security education through e-learning. The company has also prepared for the establishment of CSIRT* for cybersecurity.
*Computer Security Incident Response Team

Otsuka Electronics
At Otsuka Electronics, all employees have participated in the e-learning program for information security in order to understand the rules they should follow, learn the basic knowledge, and raise awareness of security.

Otsuka Techno
Otsuka Techno aims to balance the safety of information system and user-friendliness.  To this end, the employees in charge of information systems and the information system department personnel are working in cooperation to establish and disseminate the company-wide operation rules, and promote the initiatives, including the installation and development of devices and software. The meetings to review the company-wide direction, measures, and operations of information security, and the approach toward the Otsuka group’s overall initiatives are held on a regular basis, including all the aforementioned personnel involved in information systems.

EN Otsuka Pharmaceutical
In fiscal 2017, EN Otsuka Pharmaceutical conducted the drills against targeted email attacks for email users. The results have been announced in the compliance training to share and raise awareness across the company about targeted email attacks as well as the threats and risks of the attacks. The company is currently reviewing the content of information security training conducted when employees join the company, so that the training can be implemented in accordance with the job role of each employee.
Otsuka Holdings, Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Otsuka Foods, Otsuka Electronics, Otsuka Techno
Quality
Safety Initiatives
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Quality and Safety Control

The Otsuka group, placing its ultimate priority on customers and patients a...

Quality
Safety Initiatives
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Global Quality Assurance System for IV Solutions

In research and development of pharmaceuticals, we endeavor to improve reli...

Quality
Safety Initiatives
Response thumb thumb2016 qua02

Research and development activities

R&D themes The Otsuka group provides total support for people’s health...

Quality
Safety Initiatives
Response thumb img 3275

BCP and BCM Establishment

The Otsuka group has business continuity plans (BCP) in place to ensure tha...

Quality
Safety Initiatives
Response thumb thumb2016 qua02

Initiatives with Business Partners (Suppliers) and CSR Procurement 

In order to seek the sustainable development of the group and society, the ...

Quality
Safety Initiatives
Response thumb thumb2016 qua02

Basic policy on measures against counterfeit drugs

Counterfeit pharmaceutical products* are products that do not contain the i...

Quality
Safety Initiatives
Response thumb %e3%81%8a%e5%ae%a2%e6%a7%98%e3%81%ae%e5%a3%b0%e3%82%92%e8%81%9e%e3%81%8f%e4%bd%93%e5%88%b6

Listening to Customers

In order to field and respond to customer inquiries appropriately, the Otsu...

Quality
Safety Initiatives
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Information Security Initiatives

The Otsuka group has formed the Otsuka group Information Security Committee...

Quality
Corporate Governance
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Basic Position on Corporate Governance

Otsuka Holdings is committed to pursuing steady growth in its corporate val...

Quality
Corporate Governance
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Governance System

At Otsuka Holdings, the Board of Directors, which includes outside director...

Quality
Compliance
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Implementing Otsuka Group-Wide Training—Global Code of Business Ethics and a Global Anti-Corruption Policy

In order to promote and achieve group-wide compliance under the banner of i...

Quality
Compliance
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Promoting Compliance

The Otsuka group of companies formulates their own individual programs to p...

Quality
Compliance
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Enhancing the Internal Whistleblowing System

Japan’s Corporate Governance Code calls for the establishment of an interna...