About Ono

Manufacturing

Enhancing Product Value Through Stable Supply 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 for health and life science business to improve productivity for stable product supply. ONO continually reviews production systems and invests 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 also consistently perform cost management from active pharmaceutical ingredient production to commercialization, as well as manages costs of raw and labeling/packaging materials from the supplier selection stage.
We ensure that all drugs are produced, whether in-house or through outsourcing, under appropriate quality assurance system. ONO’s plants have a quality assurance system in place that is compliant with global regulations such as the US GMP and PIC/S GMP. In outsourcing production, ONO checks, through regular quality auditing, that appropriate manufacturing control and quality control are conducted.
We take various measures to stably supply high-quality drugs, including education and training of all workers involved in production and quality assurance, strengthening the quality system in accordance with ICH Q10 Pharmaceutical Quality System, and upgrading of risk management systems at our manufacturing centers.

Fujiyama Plant(Shizuoka)

Yamaguchi Plant

Strengthening Production Systems

Our manufacturing centers in Shizuoka and Osaka are compliant with GMP (a set of standards relating to the manufacturing control and quality control of pharmaceuticals). The main Fujiyama Plant
proceeds with continual improvement and expansion of its facilities. In addition to strengthening our production capabilities aimed at future business expansion, a new plant has been constructed in Yamaguchi to mitigate the risk of major disaster from the business continuity perspective. This new plant is now in the final stages of verification before beginning operation. Equipped with a production line for highly active antibody drugs, the plant is planned to produce injections including anticancer drug OPDIVO and multiple myeloma drug KYPROLIS. The plant is scheduled to start operation in spring 2020 upon completion of regulatory procedures, including obtaining drug manufacturing license, 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. In addition, the Corporate Regulatory Compliance Safety and Quality Assurance Division, containing a section responsible for data, also uses and utilizes medical databases to analyze pharmaceutical product profiles and safety information for proper use.


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 have relevant departments jointly conduct periodical drills in preparation for product recall to check that they can be executed quickly even in unexpected circumstances.