About Ono

Manufacturing

To Ensure Stable Delivery of Drugs

At ONO, all the divisions involved in manufacturing cooperate closely with each other and they consistently maintain a strong sense of responsibility and ethics as they faithfully practice evidence-based manufacturing operations according to the operating procedures and continuously make maximum efforts for the stable supply of high-quality drugs.


Initiatives to Ensure the Stable Supply of High-quality Drugs


Improving Productivity

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 pharmaceutical substances through to products.

Improvement of Quality Check System Reliability
We deliver only products that have been ascertained to have assured quality by monitoring safety and efficacy information and by checking manufacturing and testing records as well as visually inspecting all products.

Human Resources Development
We strive to develop our human resources through specialist training for workers involved in production, passing skills from experienced technicians to young employees, in-house personnel exchange, and training in anticipation of globalization.

Risk Management
We have a risk management system in place to ensure stable drug supply. Our system is based on proper production facility management, ensuring proper product quantities, and avoiding the impacts of power outages by equipping production centers with emergency power provisions.

Fujiyama Plant(Shizuoka)

Production Centers with Established High Quality and Productivity

Our production centers in Shizuoka and Osaka are compliant with GMP (a set of standards relating to the manufacturing control and quality control of pharmaceuticals). The Fujiyama Plant, our key production center, newly constructed in Fujinomiya City, Shizuoka Prefecture in 1975, has continually improved and expanded its facilities, so that today the plant boasts computer-controlled manufacturing facilities. In 1999, a large-scale injection manufacturing plant was constructed within the grounds of the Fujiyama Plant, equipped with high-performance automation facilities. In 2009, a solid formulation manufacturing plant equipped with state-of-the-art manufacturing facilities was newly constructed. In 2014, an injection line equipped with manufacturing facilities to handle highly active and antibody drugs was completed and came online, including facilities that can handle new drugs from the investigational drug manufacturing phase.
The injection manufacturing plant is equipped with high-performance facilities and world-class software that comply not only with Japanese but also European and U.S. GMP standards. Computers are used to give all the necessary operational commands in the manufacturing process, to check such operations, and to collect and record data. Industrial robots are used in all processes, from receiving pharmaceutical substances to the dispatch of finished products. The solid formulation manufacturing plant utilizes high-speed, high-performance machinery for thorough quality assurance. In August 2016, a new warehouse was completed at the Fujiyama Plant. This facility is intended to serve to manage products and materials that increase in line with new product launches and to stockpile products in the event of natural disasters.
In addition to strengthening our production capability aimed at future business expansion, we have decided to build a new factory for the first time in some 40 years after the construction of the Fujiyama Plant, so as to mitigate the risk of major disaster, from the business continuity perspective. The factory will be built in Yamaguchi prefecture, with operations scheduled to commence in 2020. We are committed to strengthening our capabilities for the stable supply of drugs.

Safety and Quality Assurance

To Ensure Drug Reliability

Drugs are taken up into the body, they act on the body, and they also influence various biological reactions. Being a company that handles products involved with life, we continually engage in quality assurance and promotion of proper use to ensure the reliability of the drugs we deliver.


Quality Assurance Policy

We not only meet the legal requirements as a manufacturer and marketer, 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 pharmaceutical products that are assured to a high quality standard.


Initiatives for the Proper Use of Pharmaceutical Products

Providing safety information aimed at proper use is an important undertaking for pharmaceutical manufacturers in order for patients and medical practitioners to use drugs with peace of mind. ONO has set out a drug risk management plan and gathers and manages information on safety (adverse effects) by monitoring safety.As part of our safety measures, we collect information from patients and medical practitioners, academic papers, and post-marketing surveillance, we assess that information, and if necessary we revise the cautions on package inserts and make announcements about proper use.


Maintenance of Product Recall System

We have a system in place to recall any products with problems concerning efficacy, quality or safety, 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.