About Ono

Manufacturing

For the Stable Supply of Drugs that Can Be Used with Peace of Mind

Pharmaceuticals are products concerned with life, they play a crucial role in maintaining health and in treating diseases. It is necessary to assure their quality to a high standard and to ensure their stable supply. Accordingly, we not only meet the legal requirements as a manufacturer and marketer, but also create our own quality manual to establish a drug quality system and work to develop and continuously improve quality pharmaceutical products 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.


Efforts to Ensure Reliability

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 perform evidence-based manufacturing operations and continuously make maximum efforts toward the stable supply of drugs of assured quality.
We also have a system in place to ensure reliability through preparation of drug risk management plans and operation of the drug quality system, so that patients and medical professionals can use our pharmaceutical products in a safe and reliable manner.


Production System Optimization

We continually review production systems and invest in suitable 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.


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.


Productivity Improvement

We strive to improve productivity, driving laborsaving initiatives such as automation of production processes, as well as careful examination of cost structures, from pharmaceutical substance to pharmaceutical production.


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.


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 conduct periodical drills in preparation for recall to check that product recalls can be executed quickly even in unexpected circumstances.


Efforts toward the Proper Use of Pharmaceutical Products

We strive to prevent medication errors through various measures, including clear labeling on containers to avoid drug confusion by patients, their families and medical professionals, as well as printing the drug name and contents clearly on PTP sheets even after they are split up.
We are also developing packaging of products on which necessary information can be marked to prevent patients from misusing them.
Collecting and providing drug safety (side effects) information is a crucial role for pharmaceutical companies. The information is collected through reports from patients and medical professionals, reviews of academic papers, surveys conducted by pharmaceutical companies and other means. We assess the collected information and accordingly revise precautionary statements in the package inserts when necessary.

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, 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 May 2014 an injection line equipped with manufacturing facilities to handle highly active and antibody drugs was completed, including facilities that can handle new drugs through development 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 gather 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.