About Ono


To Ensure Stable Delivery of High-Quality Drugs

At ONO, all the divisions involved in manufacturing cooperate closely with each other and consistently maintain a strong sense of responsibility and ethics as they faithfully practice scientific evidence-based manufacturing operations according to the operating procedures and continuously make maximum efforts for the stable supply of high-quality drugs. We are committed to strengthening our capabilities in both hardware and software related to manufacturing activities for the stable supply of drugs.

Initiatives to Ensure Stable Supply of High-Quality Drugs

It is essential to improve productivity for stable product supply. We continually review production systems and invest appropriately in plant and equipment for further optimization of marketed products, while keeping in mind the timing of marketing, quantities and product features relevant to the production system structure for products destined for market launch. We are also consistently managing costs, from active pharmaceutical ingredient production to commercialization.
All pharmaceutical products are manufactured under our proper quality assurance system. Our manufacturing factories have the quality assurance system that is compliant with the global regulations such as U.S. GMP and PIC/S GMP as well as the Japanese GMP (standards relating to the manufacturing control and quality control for drugs). For example, we use only raw materials and packaging materials conformed to the specifications, and regularly conduct quality audits to those suppliers to evaluate their qualification. When we use outsourcing of drug manufacturing, we make sure by regularly quality audits that the contract manufacturers adequately perform the manufacturing control and quality control.
By strengthening the quality system based on “Guideline of ICH Q10 PHARMACEUTICAL QUALITY SYSTEM”, we are making efforts to prevent quality and safety issues.
We take various measures to stably supply high-quality drugs, including education and training of not only plant workers but also all other workers involved in production, and upgrading of risk management systems at our manufacturing centers.

Fujiyama Plant(Shizuoka)

Yamaguchi Plant

Strengthening Production Systems

Our manufacturing plants located in Shizuoka and Osaka are compliant with GMP. The main Fujiyama Plant has continually improved and expanded its facilities since its establishment.
In addition, we have established a new plant in Yamaguchi to strengthen our production capabilities for future business and mitigate the risk of major disaster from the business continuity perspective. Equipped with a production line for highly active antibody drugs, this plant is scheduled to start operation in 2020 to serve as a manufacturing center that will support ONO’s production capabilities together with the Fujiyama Plant.

Safety and Quality Assurance

Enhancing Product Value Through Drug Reliability Assurance Activities

From a patient standpoint, ONO conducts drug reliability assurance activities with global perspective through drug life cycle to constantly check for drug quality assurance and reflect opinions from healthcare professionals and patients on further quality improvement. In addition, we analyze and assess, based on latest scientific evidence, drug quality and efficacy and safety (adverse reaction) information collected from, e.g., reports from patients and healthcare professionals, literature, and surveys, to constantly provide updates to the frontline of healthcare

Quality Assurance Policy

We not only meet the legal requirements as a marketing authorization holder, but also set out our own quality manual to establish a drug quality system and work to continuously improve systems so as to provide high-quality drugs from the viewpoints of patients, caretakers and healthcare professionals. In addition, we contribute to society through stable supply of pharmaceuticals that are assured to a high-quality standard.

Initiatives for Proper Use of Pharmaceuticals

We develop a risk management plan and collect and manage safety (adverse reaction) information for each pharmaceutical. We assess collected data and information, and if necessary revise the cautions on package inserts and make announcements about proper use. As safety information drastically increases inside and outside Japan after market launch of antineoplastic drugs, we assess such information based on opinions from external medical experts to promote the proper use of the drugs, e.g., by disseminating it through promotional materials, conference presentations, and medical journals.

Maintenance of Product Recall System

We have a system in place to recall any products with efficacy, quality or safety problems and to promptly provide medical professionals with information on them. We also conduct periodical drills in preparation for product recall to check that they can be executed quickly even in unexpected circumstances.