Quality Control and Patient/Customer Safety


Group-wide Cooperation to Ensure Stable Supply of High-Quality Products

Basic Policy

At the Otsuka group, we believe that providing a stable supply of high-quality products is part of our contribution to a sustainable society. Accordingly, we make the most effective use of the characteristics of our businesses, which include pharmaceuticals, foods, chemical products, and cosmetics, in the quest for a level of quality that justifies customers’ faith in us. To that end, we believe it is vital to pursue talent development across departmental borders, to maintain a reliable quality assurance system spanning all relevant companies (which also has the advantage of enabling us to stay up to date with changes in the operating environment), to minimize quality risks, and to undertake dynamic initiatives that contribute to supply chain stability.

An Enduring Philosophy of “Customers First” and “Quality First”

Quality is vital in a factory and so is packaging.
We have to manufacture and market,
putting ourselves in the consumer's position.

Otsuka's founder, Busaburo Otsuka, is still referred to with fondness by employees as “Oyaji-san” (an informal term of address often used to mean “old man” or “father”). In 1946, when the Company began the manufacture and sale of injection drugs, Busaburo wrote the above guiding principles to clarify what his employees should do to ensure proper manufacturing, transportation, and sales. Today still, these principles are on display at the Company's manufacturing sites and other facilities, conveying our philosophy of “Customers First” and “Quality First.”

All employees of the Otsuka group will remain true to this philosophy, and now as in the past, our responsibility as a health-related company will always be to think of customers and quality first.

The Otsuka group’s systems for production, quality, and safety management follow all laws and regulations, administrative instructions, and industry standards (including those prescribed by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and the Food Sanitation Act). Furthermore, we aim not only to obtain appropriate standards certification (ISO 9001 for quality, ISO 22000, and FSSC 22000 for food safety), but also to foster a “quality culture” that goes beyond the minimum obligations required by law. In order to ensure the stable supply of safe and secure products to patients and customers, we have formulated quality policies for each group company, and under the leadership of top management, we are continually working to enhance the quality of our products and services.

Promotion System for Pharmaceutical Business

The Otsuka group aims to both improve and maintain product quality guided by international standards in response to requirements in laws and regulations as well as look to improve the functionality of products and ensure a stable supply. For example, Otsuka Pharmaceutical has formulated the Policy for Pharmaceutical Quality Assurance, seeking to establish a high-level quality assurance system where all activities in all processes are based on this policy, including those undertaken by external contracted manufacturers. The Pharmaceutical Business established global product quality policy in 2017. Activities are carried out globally, and include ensuring the reliability of quality data and compiling procedural manuals.

Promotion System

The pharmaceutical segment of the Otsuka group complies with the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and we observe the laws and regulations of the countries where we operate, performing quality control based on Good Quality Practice1 and Good Vigilance Practice2 in manufacturing and sales, and implementing post-marketing safety measures. Moreover, we submit all necessary reports, including those on adverse events , to regulatory authorities, and update and maintain all required documentation (Pharmacovigilance3). In addition, we ensure that all pharmaceuticals are manufactured under a quality assurance system to enable the stable supply of high-quality pharmaceuticals. We have established a quality assurance system that complies with international standards, such as GMP4 in each country and PIC/S5 GMP. We are also strengthening the quality control system based on the ICH Q10 Pharmaceutical Quality System Guidelines.

  • 1:Standards for quality assurance in production and sales (GQP). In Japan, GQP is defined in a ministerial ordinance issued by the Ministry of Health, Labour and Welfare based on the Pharmaceutical and Medical Devices Act. The official name is the Ministerial Ordinance on Standards of Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices.
  • 2:Standards for post-marketing safety management (GVP). Good post-marketing study practice (GPSP) and GVP are elements of post-marketing surveillance. GVP mandates the establishment of rules for the collection and monitoring of safety information, and the implementation of necessary safety measures after pharmaceuticals and medical devices are launched in the market. In Japan, GVP is defined in a ministerial ordinance issued by the Ministry of Health, Labour and Welfare based on the Pharmaceutical and Medical Devices Act. Its official name is the Ministerial Ordinance on Standards for Post-Marketing Safety Control of Drugs, Quasi-drugs, Cosmetics, Medical Devices, and Regenerative Medicine Products.
  • 3:Pharmacovigilance refers to monitoring of drug safety information. It helps to promote appropriate use of drugs and protect patient safety by detecting, evaluating and preventing adverse reactions.
  • 4:Standards designed to ensure proper manufacturing control and quality control in all processes from the receiving of raw materials to the shipment of final products. In Japan, GMP is defined in a ministerial ordinance issued by the Ministry of Health, Labour and Welfare based on the Pharmaceutical and Medical Devices Act. Its official name is the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs.
  • 5:Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the informal cooperative arrangement between regulatory authorities aimed at the international development, implementation and maintenance of harmonized GMP standards and quality systems for inspecting in the field of medicinal products.

Safety Management

The Otsuka group has established a safety management system that consists of the Quality Assurance Manager, who is responsible for the quality control of pharmaceuticals as required by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Under this system, the Safety Control Manager responsible for post-marketing safety management and the General Marketing Compliance Officer oversees compliance. This ensures that actions taken for quality and safety are performed accurately. We also hold monthly debriefings for everyone from the General Marketing Compliance Officer to management.

The Triumvirate Structure in the Manufacture and Sale of Pharmaceuticals

Since 2016, Otsuka Pharmaceutical and group companies have enhanced compliance for a range of processes from development through to the finished product. Monthly debriefings are held with the director in charge of quality in addition to management reviews three times a year. The Nutraceutical Business holds monthly debriefings and quality assurance meetings with the director in charge of quality as part of a thorough quality management system.

Participation in Activities to Raise Awareness of and Eradicate Counterfeit Medicines

Annual worldwide sales of falsified (counterfeit) medicines1 are estimated at more than $75 billion.2 In developing countries, where these medicines reportedly account for 10–30% of drug distribution, the safety of patients is seriously threatened. Otsuka Pharmaceutical participates in raising awareness of and eradicating falsified medicines in collaboration with the Pharmaceutical Security Institute (PSI).3 Otsuka Pharmaceutical and subsidiaries outside of Japan have formed a global product security team that practices market surveillance and cooperation with industry and government so that medicines reach patients through the correct distribution channels. This structure was strengthened in January 2021, and members with expertise from production, quality, procurement, and logistics departments are participating in cross-organizational activities.

  • 1:The definition of falsified medicines was discussed at the 2017 WHO World Health Assembly. WHO defined falsified (counterfeit) medicines as “medical products that deliberately/fraudulently misrepresent their identity, composition or source.
  • 2:Growing threat from counterfeit medicines” (Bulletin of the World Health Organization, Volume 88, Number 4, April 2010, 241–320)
  • 3:Forty pharmaceutical companies from around the world fund the Pharmaceutical Security Institute's (PSI) anti-counterfeit medicine efforts (information gathering, collaboration with law enforcement, and awareness-raising activities).

Global Quality Assurance Officers’ Meeting

Otsuka Pharmaceutical Factory insists on manufacturing IV solutions in the country where they are sold because we believe in supplying pharmaceuticals at fair prices for every country or region so that all people can receive medical treatment equally, whether they are rich or poor. The Otsuka Global Quality Standards have been set to maintain high quality in every country that manufactures our products, aiming to further improve quality. We send young engineers to other countries to oversee production, which also presents a huge opportunity for personal growth for those employees. The Global Quality Assurance Officers’ Meeting is held every year for 15 group companies across 10 countries engaged in the IV solutions business. IV solutions require stricter quality control than other pharmaceuticals, since they are administered directly into the body.
While establishing a framework for exchanging safety data throughout the group, we are working as one to unify our approach to quality assurance and steadily maintain and improve product quality.

Promotion System for the Nutraceutical Business

In 2018, Otsuka Pharmaceutical established the Quality Division for making possible quality improvements and safety control for products in the Nutraceutical Business. The Global Product Quality Team consisting of members from 15 Otsuka group companies has begun formulating a common philosophy on quality and the NC Global Quality Policy was established in 2021.

Ken Konagai
Office of Nutraceuticals
Quality Assurance
Quality Headquarters
Otsuka Pharmaceutical

Commitment to the NC Global Quality Policy

In 2018, Otsuka Pharmaceutical’s Quality Assurance Office of the Quality Headquarters inaugurated a Global Product Quality Team, with members from 14 Otsuka group companies from around the world involved in the Nutraceutical Business. Otsuka Pharmaceutical’s approach to quality is rooted in, and remains faithful to, founder Busaburo Otsuka’s words: “Quality is vital in a factory and so is packaging. We have to manufacture and market, putting ourselves in the consumer’s position.”
The key message of the NC Global Quality Policy is “Customer delight through Quality,” which expresses the founder’s sentiment in our own words and declares our common global commitment.

Promotion System

Otsuka Pharmaceutical established a Quality Assurance Office. Based on the concept of good manufacturing practice for pharmaceuticals, the Global Product Quality Team, consisting of members from 15 group companies, built an integrated management system that ranges from identifying and investigating risk to examining the cause of issues that arise and taking effective countermeasures. As an example, in December 2020 Otsuka Pharmaceutical formulated rules for evaluating the quality of nutraceutical products from development to marketing to prevent risks to quality in all aspects of the value chain.
In addition, we are promoting more quality improvements, such as acquiring international certifications at production bases to ensure global quality assurance.

Acquisition of International Certification (Nutraceutical and Consumer Products)

Company name Certificate factoryISO 9001 quality management system Food safety management systemOthers
Otsuka Pharmaceutical Second Tokushima Factory
Otsuka Pharmaceutical Tokushima Itano Factory
Otsuka Pharmaceutical Tokushima Wajiki Factory
Otsuka Pharmaceutical Saga Factory
Otsuka Pharmaceutical Takasaki Factory
Otsuka Pharmaceutical Fukuroi Factory
Otsuka Foods Tokushima Factory HACCP
Otsuka Foods Shiga Factory HACCP
(Beverage manufacturing line)
Otsuka Foods Kushiro Factory HACCP
Otsuka Foods Gunma Factory HACCP
Amerta Indah Otsuka
Sukabumi cGMP
Amerta Indah Otsuka
Otsuka Sims (Guangdong) Beverage(OSGB) First Factory,
Second Factory
Tianjin Otsuka Beverage (TOB) Tianjin Factory HACCP
Pharmavite San Fernando FDA,
Pharmavite Opelika FDA,
Crystal Geyser Water Bakersfield
Crystal Geyser Water Calistoga
Daiya Foods Burnaby SQF
  • *FSSC22000: Food safety management system standard
  • *HACCP: Hygiene management system
  • *c-GMP (Current Good Manufacturing Practice): One of the food and drug quality control programs established by the U.S. Food and Drug Administration (FDA)
  • *USP (United States Pharmacopeia): Quality standard for U.S. pharmaceuticals (including supplements)
  • *BRC Global Standard: Food safety standard run by the British Retail Consortium
  • *IBWA (International Bottled Water Association): Trade association of companies in the bottled water industry
  • *IFS (International Food Standard) certification: Food safety standard for EU countries
  • *SQF (Safe Quality Food): US food safety and quality control certification

Listen to the Customer Feedback Meetings

We collect post-marketing information on Otsuka Pharmaceutical’s nutraceutical products. Feedback provided to the Consumer Relations Office is shared with production and technology departments at monthly meetings of the Quality Assurance Office of the Quality Headquarters. The goal is to make and check the progress of product improvements. Listen to the Customer Feedback Meetings have been held every year since 2018, and they have gradually gotten bigger. At these meetings, representatives from purchasing, production, quality, compliance, legal affairs, and Otsuka Holdings share information and work to improve quality from a customer perspective.

See Customer Service page here

Initiatives to Improve Product Quality through Collaboration between Pharmaceutical and Nutraceutical Businesses

Global Product Quality Meeting

In Otsuka Pharmaceutical's product quality operations, the Pharmaceutical Business and Nutraceutical Business jointly hold an annual Global Product Quality Meeting. The 2022 meeting was attended by approximately 120 managers and quality supervisors for pharmaceuticals and nutraceuticals from 12 countries/regions, including Japan, on the topic of creating new synergies for future quality management. Participants shared information on quality-related risks in the supply chain and their countermeasures as well as quality assurance initiatives within environmental conservation programs. In addition, a Quality Performance Award was established to recognize quality control initiatives, and we are training more people for quality control and to raise awareness.

Global Product Quality Meeting, Quality Achievement Award, Grand Prize

Quality Culture Secretariat* consisting of members from Otsuka Pharmaceutical’s production, quality and quality assurance departments

  • *Leads and promotes “quality culture” development across divisions in the Pharmaceutical and Nutraceutical businesses.

PT Amerta Indah Otsuka’s Quality Assurance Department
Developed and started operating a digital management system that streamlines vendor management through vendor audits, the sharing of results from incoming inspections for raw materials and other materials online, and the centralized management of onsite data. This initiative was aimed at ensuring compliance with FSSC22000 Food Safety System Certification version 5.1.

Human Resource Development and Education System

In addition to regular training on quality for the employees and other people concerned in accordance with an annual plan, we provide training on topics including: company and manufacturing site rules; safety, health and the environment; and manufacturing management and quality control in relation to products and their manufacture. Depending on the content, human resource development includes practical programs for learning procedures and skills.
For example, Otsuka Pharmaceutical provides education for new recruits, training to improve skills for employees in their second or third year with the company, and training for people to confirm the content of tests, each around 10 times a year.