Quality Assurance and Stable Supply

Ensuring a Reliable Supply of High-Quality Medicines

Global Quality Assurance

All JCR manufacturing sites operate in compliance with PIC/S GMP. From raw material procurement and manufacturing to product release and distribution, we maintain a quality system grounded in science and continuously work to further strengthen it. In manufacturing our biologics, we use single use equipment and components and source media and reagents from a wide network of suppliers in Japan and overseas, including customized materials. To ensure quality, we establish multi year agreements and conduct regular risk based on site audits.

Consistency in Quality

Biologics require more advanced manufacturing and quality control than small molecule drugs, along with rigorous production and testing plans. Each site sets clear quality objectives to ensure the consistent product quality and reviews performance against these goals annually. To support global expansion, we operate a unified quality system across all sites. Our integrated quality control function, incorporating analytical method development, enables seamless management from early stage method design through release testing for commercial production. Progress toward quality objectives is reported to executive management once a year.

Securing Stable Supply

Many of JCR’s therapies are administered over the long term, making reliable supply essential for patients. Biologics also require longer and more complex manufacturing processes than small molecule drugs. To maintain stable supply, we secure appropriate inventory levels and manufacture at our domestic facilities to allow flexible scheduling.
As overseas demand grows and to enhance supply resilience in emergencies, we are also considering production at overseas sites and the storage of key intermediates abroad.

Ensuring Product Safety

Pharmacovigilance System

Because safety at approval is based on limited clinical data, we conduct post marketing surveillance in line with the Risk Management Plan, continuously collecting and evaluating safety and efficacy information. All safety data are reviewed promptly to determine whether further measures are required, and accumulated data are assessed periodically to detect any changes in the frequency or pattern of adverse events. When action is necessary, information is communicated swiftly and appropriately to healthcare professionals and other relevant stakeholders.
These activities are carried out in full compliance with applicable laws and regulations. We also provide regular training to medical representatives and to departments responsible for safety management to reinforce the importance of information collection and strengthen safety awareness across the organization.

Three Officer Governance Structure

In accordance with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, JCR has established a 3 officer governance structure comprising the Marketing Authorization Holder Executive, the Head of Quality Assurance, and the Head of Safety Management. Operating independently from the Sales and Manufacturing divisions, this structure provides scientific oversight of product quality and safety and determines whether products may be released, recalled, or subject to additional safety measures. Through this independent governance framework, JCR upholds the quality and safety of its products.