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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 has established rigorous quality control systems suited to the characteristics of each of its businesses, including pharmaceuticals, medical devices, 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.
In 2016, Taiho Pharmaceutical developed a collaborative system to work with authorities and other pharmaceutical companies both in and outside of Japan on counterfeit drug investigations and remedial actions. During manufacturing, for example, the company attaches a separate dedicated barcode to each box of TS-1 capsules distributed in China, in order to protect users from counterfeit drugs circulating in the country.
 

Quality Control in the Otsuka Group

Otsuka group, Taiho Pharmaceutical

A Leading Manufacturer of IV Solutions

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The Otsuka group constantly strives to increase the reliability of its pharmaceutical research and development by complying with mandated rules and regulations related to non-clinical and clinical trials (GLP and GCP). It also works to verify and appropriately manage data in order to ensure not only the efficacy of candidate pharmaceuticals, but their safety, as well. In manufacturing, the group has developed and applies a GMP system designed to maintain excellent product quality and then improve it even further. The group manages quality, safety, and distribution of its pharmaceutical products, on the basis of GQP, GVP, and GDP standards throughout the entire process from manufacturing to sales, reporting to the regulatory authorities as required and compiling and revising various documents. As part of its safety supervision (pharmacovigilance), the Otsuka group continually gathers and evaluates information on the safety of its products and shares its findings with medical institutions and sales distributors.
Today, countries around the world are accelerating their efforts to establish more rigorous standards regulating pharmaceutical quality and safety. With this trend, they are also pursuing particularly tough quality controls on IV solutions, treating them as intravenously administered drugs. As a leading manufacturer of IV solutions, Otsuka Pharmaceutical Factory technically cooperates with and manages the Otsuka group’s IV solutions business outside Japan. In this leading role, the company has voluntarily developed and implemented a strict global quality assurance system. With 15 Otsuka group companies (in 10 countries) involved in the IV solutions business, the group works together to continuously maintain product quality, and then improve it even further. This is accomplished by executing on a shared philosophy of quality assurance via a structure for sharing information on safety and complying with laws, regulations and industry standards in each country where the group operates.
Otsuka Pharmaceutical Factory

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.
Major Otsuka group companies such as Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, and Otsuka Warehouse have jointly acquired ISO 22301 certification (the international standard for business continuity management systems). This certification verifies that the Otsuka group provides a framework capable of ensuring the stable supply of pharmaceuticals, food products, and beverages in both ordinary and emergency conditions. In 2016, major Otsuka group companies conducted joint desktop exercises simulating a severe earthquake along the Nankai Trough. Company offices in Tokushima, Tokyo, and Osaka communicated via video conferencing to test the group’s collaborative structure for ensuring a stable supply of products under simulated conditions, and 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.
In May 2016, Taiho Pharmaceutical acquired ISO 22301 certification, which verifies that the company provides a framework capable of ensuring the stable supply of anticancer drugs. This follows certification in 2015 of Otsuka Pharmaceutical Factory’s framework for guaranteeing a stable supply of IV solutions, effectively strengthening the Otsuka group’s overall capacity for business continuity.
Otsuka Techno has developed crisis management plans (BCP/BCM) to address the potential of a severe earthquake along the Nankai Trough and other major disasters. As part of its efforts to assist employees during emergencies, the company has distributed and stored emergency water and food supplies at the Naruto head office and plant, the Wajiki plant, and the Tokyo office, as well as evacuation equipment at the Naruto head office and the Naruto and Wajiki plants.
Otsuka Electronics maintains stockpiles of emergency supplies at all of its business locations for employees who are unable to return home. These supplies are regularly checked and restocked 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 Suppliers

The Otsuka group is committed to working and growing with suppliers whose operations are rooted in corporate social responsibility. It focuses on providing solutions for the issues that communities face through its suppliers and making sure that transactions do not cause social issues.
The Otsuka group enacted a group-wide procurement policy in 2016 and distributes a CSR procurement questionnaire to evaluate CSR activities within the supply chain. Working together with suppliers, the Otsuka group is determined to build relationships of even greater mutual trust by upholding its social responsibilities. This effort is based on ensuring a clear understanding throughout the supply chain of the current status of human rights, labor, environmental circumstances, and corruption prevention.
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.

Procurement Policy
1.Building Relationships of Trust
We respect all suppliers equally as valuable collaborators; conduct procurement transactions fairly, justly and transparently; and pursue mutually sustainable development as we build positive relationships of trust.

2.Stable Supply
We ensure the reliable level of quality that our customers expect; provide fair and honest opportunities for bidding by suppliers around the world that provide safe, quality, environmentally friendly, and cost competitive raw materials; and select the bid winners based on rational and fair criteria.

3.Product Development Ideas
We actively evaluate proposals for new materials, new technologies, and revolutionary ideas that will lead to new products.

4.Boosting Competitiveness
We aim for products that are optimal in every respect, not only optimal in certain respects. We evaluate all economically rational ideas for boosting competitiveness.

5.Environmental Measures, Human Rights, and Labor
We actively pursue initiatives that address corporate social responsibility and environmental issues, aiming to help build a sustainable society. At the same time, we support internationally recognized norms within the scope of our impact on respect for basic human rights, the elimination of forced labor, and the prevention of child labor, and we pursue initiatives toward these goals.

6.Protecting Confidentiality
We do not use confidential information from suppliers obtained in the course of doing business for any purpose other than the original purpose for which it was provided. We do not leak confidential information to third parties.

7.Promoting Compliance
We conduct our operations in accordance with socially accepted norms, complying with all relevant laws, rules, and regulations and upholding high ethical standards.

8.Risk Diversification
As a basic rule, we purchase major items from multiple companies to reduce risk and ensure that we deliver a stable supply of products to our customers regardless of weather, natural disasters, or other conditions.
Otsuka group, Otsuka Pharmaceutical Factory, EN Otsuka Pharmaceutical, Otsuka Electronics

Listening to Stakeholders—Otsuka Pharmaceutical Factory

Otsuka Pharmaceutical Factory has established the IV Drug Information (DI) Center to field various inquiries by telephone. Answers to questions are also posted via the FAQ page on the company’s website for healthcare professionals. In addition, the company fosters dialogue with stakeholders by giving poster presentations at pharmaceutical-related conferences.
In 2016, it presented on IV fat emulsion, electrolytes solutions, and website usage at four conferences. The entire team at the DI Center works together to provide information to pharmacists and other healthcare professionals, befitting a leading manufacturer of IV solutions. This helps to ensure the proper use of pharmaceuticals. Inquiries from patients, their families, healthcare professionals and other stakeholders are fielded by the department that deals directly with the question presented. The company listens carefully to each stakeholder and strives to answer all questions conscientiously, honestly and in a manner that is easy to understand.
Information related to the safety and quality of any product that emerges from these inquiries is immediately reported to the relevant departments. The company utilizes the information in order to monitor risks, ensure proper use of drugs, and develop and improve its products.
Otsuka group

Listening to Customers

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Otsuka Pharmaceutical Factory: IV Drug Information (DI) Center

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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. These channels form a system by which the company is able to respond appropriately to customer questions, inquiries, and feedback.
Otsuka Chemical uses customer satisfaction surveys to collect candid customer feedback in order to leverage its original chemical compounds to create a wide range of solutions.
Otsuka Pharmaceutical Factory has established the IV Drug Information (DI) Center to field various inquiries by telephone. The company also provides answers to questions via the FAQ page on the company’s website and presents information at pharmaceutical-related conferences.
Otsuka group, Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, Otsuka Chemical

Information Security Initiatives

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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.
Individual Otsuka group companies are involved in various initiatives. Otsuka Foods attends the Group Information Security Conference, where it shares information regarding information security and the protection of personal information with other group companies. Continuing with efforts from the previous year, the company conducted additional e-learning programs in December 2016.
November is designated as compliance strengthening month, and Otsuka Electronics marked this month with e-learning courses for all employees to review the list of absolutely mandatory rules, provide a basic familiarity with compliance, and raise awareness of information security.
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 has established rigorous quality control systems suited to...

Quality
Safety Initiatives
Response thumb  %e7%94%9f%e7%94%a3 01 %e7%94%9f%e7%94%a3%e6%b4%bb%e5%8b%95%ef%bc%bf%e5%86%99%e7%9c%9f img 0698

A Leading Manufacturer of IV Solutions

The Otsuka group constantly strives to increase the reliability of its phar...

Quality
Safety Initiatives
Response thumb thumb2016 qua02

Quality
Safety Initiatives
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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 Suppliers

The Otsuka group is committed to working and growing with suppliers whose o...

Quality
Safety Initiatives
Response thumb thumb2016 qua02

Listening to Stakeholders—Otsuka Pharmaceutical Factory

Otsuka Pharmaceutical Factory has established the IV Drug Information (DI) ...

Quality
Safety Initiatives
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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

The corporate governance of the Otsuka group, which seeks to promote the in...

Quality
Corporate Governance
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Corporate Governance Structure

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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Expanding the Internal Whistle-blowing System

Japan’s Corporate Governance Code calls for establishing a whistle-blowing ...