Production, Quality Control and Patient/Customer Safety

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Basic Policy

The Otsuka group always puts its customers first. In seeking to make products that gain their trust, we promote collaboration and joint activities among group companies, taking into account the characteristics of each of our businesses, which include pharmaceuticals, foods and beverages, chemicals, and cosmetics.

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 so his salespeople would know what they had to do. 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.

Approach

The Otsuka group is strongly committed to quality. This commitment began with the words of Busaburo Otsuka, the founder of the Otsuka group: “Quality is vital in a factory and so is packaging. We have to manufacture and market, putting ourselves in the consumer's position.” This commitment has been passed down by employees ever since. We believe that ensuring a stable supply of high-quality products contributes to a sustainable society. As such, we believe we should focus active efforts on ensuring quality through human resource development and by building appropriate systems.
The Otsuka group's production, quality, and safety control systems comply with legal and regulatory requirements, and with governmental and industry standards, including the Pharmaceutical and Medical Devices Act and the Food Sanitation Act. Group companies also work to acquire international certifications such as ISO 9001 for quality, and ISO 22000 and FSSC 22000 for food safety.

Global Efforts to Solve Issues in Production

Plant Manager Meeting

Production departments at the Otsuka group employ a traceability system covering all stages of the supply chain, from raw material procurement to production, distribution, and sales, thereby enabling thorough management throughout the entire supply chain.
Moreover, for over 30 years, the “Global Production Meeting” has been held aiming enhancement of production technologies and sharing information group-wide. In 2020, the “Plant Manager Meeting” was held virtually and discussed the challenges and the measures around stable supply and occupational health and safety amid the COVID-19 pandemic. The meeting had approx. 100 participants including management executives from 14 countries/regions. In addition, “Failure Case Study Meetings” and “Environmental Management Information Exchange Meetings” began in 2017 and 2018, respectively. At these meetings, participants share presentations and opinions on case studies of collaborative measures and technological development to address quality, safety, cost and environmental issues, the future outlook, and overseas development.

Tokushima Itano Factory (Otsuka Pharmaceutical)

Furthermore, by recognizing employees who have made significant contributions to production activities with awards at the “Global Production Meeting”, we are laying the foundations for further improvements in productivity and advancing personnel training. As an example, at production departments of Otsuka Pharmaceutical, we developed a systematic training plan and are providing training on health and safety and GMP. Education on business continuity planning, compliance, ISO standards and FSSC 22000 is also conducted on a regular basis. In addition, regular training is provided for selected employees and managers, as well as other employees where appropriate.

Group companies Otsuka Pharmaceutical, Taiho Pharmaceutical, Otsuka Pharmaceutical Factory, Otsuka Chemical and Otsuka Foods work together with the relevant departments of the Pharmaceutical Business and Nutraceutical Business to develop technologies for the Production Division of Otsuka Pharmaceutical. They also conduct activities to improve the technical capabilities and skills of Otsuka group employees and to create innovative products.

Otsuka Pharmaceutical Factory Employees Receive the Award for Creativity in the Commendation for Science and Technology from Japan's Minister of Education, Culture, Sports, Science and Technology for 12 Straight Years

Each company in the Otsuka group in Japan works hard to make unique proposals for improvement.
For example, for 40 years Otsuka Pharmaceutical Factory has invited employees to submit proposals related to creativity, with the most useful proposals adopted and implemented. This system leads to various company improvements and raises employees' awareness of creativity. In fiscal 2020, the company received a record 113 submissions per employee, totaling approximately 76,000. Furthermore, over 99% of proposals were addressed through improvement measures. In addition, in fiscal 2020, three employees, at the Naruto, Matsushige and Toyama manufacturing sites, received the Award for Creativity in the Commendation for Science and Technology from Japan's Minister of Education, Culture, Sports, Science and Technology.*

*This commendation from the Ministry of Education, Culture, Sports, Science and Technology recognizes the achievement of outstanding results in research and development in and promotion of the understanding of science and technology. The Award for Creativity is given to those who have contributed to technology improvement with outstanding creativity in their occupational field. Employees at Otsuka Pharmaceutical Factory have received 67 of these awards over a period of 12 consecutive years (since fiscal 2010).

Quality Control and Patient/Customer Safety

The Otsuka group always puts its customers first. To this end, it has built and maintains safety control and operation systems that take into account the characteristics of each of its businesses, which include pharmaceuticals, foods and beverages, chemicals, and cosmetics. Proper assurance of quality is the foundation for the efficacy and safety that enable pharmaceutical products to be used in medical care.
In addition, while complying with the laws and regulations in each country, for example the Pharmaceutical and Medical Devices Act in Japan, we engage in quality control and post-marketing surveillance to ensure safety in accordance with GQP1 and GVP2 standards. We also make reports, as well as compile and revise various documentation, for submission to the relevant regulatory authorities. We have also established a system for constant global pharmacovigilance3 that collects and assesses product safety information, including on side effects.
We continue to promptly provide the results of our monitoring to medical institutions and other relevant parties.

  • 1GQP: Good Quality Practice. These are standards for quality assurance in production and sales. 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. Its official name is the Ministerial Ordinance on Standards of Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices.
  • 2GVP: Good Vigilance Practice. These are standards for post-marketing safety management. 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.
  • 3Pharmacovigilance 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.

Global Product Quality Team Activities for the Pharmaceutical Business

Since 2016, Otsuka Pharmaceutical and its group companies have conducted activities to enhance compliance with GxPs* for a range of processes from development through to the finished product. Among initiatives to improve quality control systems, we hold meetings attended by management personnel, as well as group-wide meetings.
The Pharmaceutical Business established global product quality policies in 2017. Activities are carried out globally, and include ensuring the reliability of quality data and compiling procedural manuals.

*GxP: Umbrella term for GCP, GVP, GMP, GDP, etc.

What is GxP (Good x Practice)?

GxP is a general term for the “Good Practice” standards (ministerial ordinances, regulations and guidelines) established by governments and other public institutions for the purpose of ensuring safety and reliability. The following are some such standards:

GCP: Good Clinical Practice. These are standards designed to protect the rights and safety of subjects in clinical trials of new drugs. In Japan, GCP 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 Good Clinical Practice for Drugs.

GVP: Good Vigilance Practice. These are standards for post-marketing safety management. 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.

GMP: Good Manufacturing Practice. These are 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.

GDP: Good Distribution Practice. These are standards for appropriate distribution of pharmaceuticals. GDP sets out basic guidelines for quality assurance in the distribution process from shipment of pharmaceuticals from manufacturing sites through to their delivery to patients.

Measures Against Falsified Medicines

Annual worldwide sales of falsified medicines1 are estimated at more than $75 billion.2 In developing countries, where falsified medicines reportedly account for 10–30% of drug distribution, the safety of patients is greatly threatened. Otsuka Pharmaceutical participates in activities to raise awareness of and eradicate 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 appropriate 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.

  • 1The definition of “falsified medicines” was discussed at the 2017 WHO World Health Assembly. WHO defined falsified 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)
  • 3Thirty-three 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).

Initiatives to Improve Product Quality for Nutraceutical Business Products

Listen to Customer Feedback Meeting

In 2018, Otsuka Pharmaceutical established the Quality Division for the purpose of further facilitating quality improvement and safety control for products in the Nutraceutical Business. Furthermore, with the establishment of the Quality Assurance Office, we have implemented a system based on GMP for pharmaceuticals. The system enables centralized management of all processes from identifying and verifying risks arising from changes, to investigating causes and taking remedial action when risks manifest. As of May 2020, all Otsuka Pharmaceutical manufacturing sites in Japan that produce nutraceutical business products are certified for the FSSC 22000 food safety standard.

Otsuka Pharmaceutical collects post-marketing product information, and shares customer feedback received by its customer service center with production and technology departments at a monthly meeting of the Quality Assurance Office in order to consider product improvements and confirm progress. Since 2018, the company has been holding an expanded Listen to Customer Feedback Meeting once a year, at which sales, production, and quality departments, as well as the compliance department and personnel from Otsuka Holdings, share information and strive to improve quality from the customer's point of view.

In December 2020, Otsuka Pharmaceutical established Rules for Quality Assessment from Development to Market Launch of Nutraceutical Products. These rules are aimed at preventing quality risks from manifesting at any point in the value chain. The company also formulated and began using the Logistics Management Procedure Manual for Nutraceutical Products in January 2021.

Training for Employees on Quality

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.

Global Efforts to Solve Issues Related to Quality

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 2021 meeting was attended by approximately 120 managers and quality supervisors for pharmaceuticals and nutraceuticals from 11 countries/regions, including Japan. Participants shared their companies' measures for future business expansion and their approaches to product inspection amid the COVID-19 pandemic. In addition, a Quality Performance Award was established to recognize quality control initiatives, and efforts are being made to train people for quality control and to raise awareness.

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