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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

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

Listening to Customers

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Otsuka Pharmaceutical Factory: IV Drug Information (DI) Center

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

Listening to Customers —Taiho Pharmaceutical

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Tiovita Drink packaging designed to prevent cuts

At Taiho Pharmaceutical, the Drug Information Office fields inquiries about pharmaceuticals and the Customer service fields inquiries about healthcare products by telephone and email. The company also established a telephone service center to field urgent inquiries outside of business hours or on holidays. Taiho Pharmaceutical has incorporated customer feedback to improve a variety of products. In 2015, for example, the company introduced new specifications to reduce paper cuts for the 10-bottle inner cases and 50-bottle exterior cardboard packaging for its Tiovita Drink series. Since conventional packaging with sharp edges can leave unexpected paper cuts, the company added tiny waves to the paper to reduce the sharpness of the box edges, making the products more comfortable for consumers. 

VOICE

写真
Helping People with OTC Medication
Hideki Yamamoto Director, Customer Service, Consumer Healthcare Administration
Taiho Pharmaceutical Co., Ltd.
 

Taiho Pharmaceutical markets the well-known Tiovita Drink series and Solmack series, as well as a large number of over-the-counter drugs. At the Customer Service, we receive a diverse range of inquiries and feedback on our products from customers. Every day, we focus on understanding precisely what our customers want to know and what they are hoping we will do, and then we respond quickly. We share information among all of the relevant departments in the company and serve as the contact point for helping these departments to incorporate customer feedback into their work.

Taiho Pharmaceutical

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 Pharmaceutical Factory
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
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A Leading Manufacturer of IV Solutions

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

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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Listening to Customers —Taiho Pharmaceutical

At Taiho Pharmaceutical, the Drug Information Office fields inquiries about...

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Safety Initiatives
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Listening to Stakeholders—Otsuka Pharmaceutical Factory

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

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Corporate Governance
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Basic Position on Corporate Governance

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

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Corporate Governance
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Corporate Governance Structure

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

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Compliance
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Promoting Compliance

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

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Compliance
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Promoting Compliance—Otsuka Pharmaceutical Factory

Otsuka Pharmaceutical Factory has established the Otsuka Pharmaceutical Fac...

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Compliance
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Promoting Compliance—Otsuka Chemical

Otsuka Chemical not only put into place a systematic compliance structure i...

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Compliance
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Expanding the Internal Whistle-blowing System

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

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Compliance
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Enhancing the Whistle-blowing System—Otsuka Pharmaceutical Factory

To maintain sound and highly transparent management, companies must create ...

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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...

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Risk Management
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BCP and BCM Establishment

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

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Risk Management
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Formulating BCP and BCM—EN Otsuka Pharmaceutical

With firsthand experience of the Great East Japan Earthquake in March 2011,...

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Risk Management
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Formulating BCP and BCM—Otsuka Chemical

Otsuka Chemical has formed a BCM Committee consisting of directors of the p...

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Risk Management
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Information Security Initiatives

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

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Risk Management
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Information Security Initiatives—Otsuka Pharmaceutical

Otsuka Pharmaceutical has established an Information Security Committee to ...

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Risk Management
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Information Security Initiatives—Otsuka Pharmaceutical Factory

Recognizing the importance of information security, Otsuka Pharmaceutical F...

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Risk Management
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Information Security Initiatives—Otsuka Techno

Otsuka Techno aims to achieve both information system safety and convenient...

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Risk Management
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CSR Procurement/Green Procurement

Recognizing the importance of working with suppliers to implement sustainab...

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Risk Management
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Initiatives with Suppliers

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