Related SDGs

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We will “realize medical care for those living with rare diseases” at the earliest opportunity by transforming every aspect of our business through “Team JCR.”

Quality Assurance and Stable Supply

Stable Supply of High-Quality Pharmaceuticals

Quality Assurance Based on Global Standard

All of JCR’s production sites have established a system that scientifically guarantees quality, encompassing the purchase of raw materials, manufacturing, shipment of products and product distribution in compliance with PIC/S GMP, an international standard, and continue efforts to raise those standards even further. JCR utilizes single-use equipment and supplies in the manufacturing of its biopharmaceutical products, with a wide range of culture medium and diagnostic agent suppliers in Japan and overseas. Because it also utilizes custom-made items, JCR enters into multiple-year contracts with suppliers worldwide and ensures quality by conducting regular on-site visits according to the level of risk.

Consistent Quality

Biopharmaceuticals require more highly sophisticated manufacturing and quality control than what is required by small molecule pharmaceuticals. Moreover, detailed manufacturing and quality test plans are required. At its production sites, JCR sets quality targets to continuously manufacture high-quality products, and evaluates the status of achievement of those targets every year. Eyeing future global expansion, we are operating a consistent quality system to ensure that no differences arise between production sites in terms of their positions on quality standards. At the same time, through the quality testing division which has been integrated with the Development Division conducting testing, we have established a quality management system that enables a streamlined process from consideration of testing methods in the early stages of research to testing during shipment for commercial production. Furthermore, the status of achievement of quality targets is reported to management once a year.

Ensuring a Stable Supply

Since many JCR products are administered to patients over the long term, an unstable supply can be directly detrimental to the interests of patients. In terms of product characteristics, JCR products require a longer period of time to manufacture than small molecule pharmaceuticals because they involve more time-consuming and complicated manufacturing processes. To ensure a steady supply of products, JCR secures appropriate levels of product inventories, along with manufacturing at its in-house manufacturing sites in Japan to allow for flexible manufacturing schedules. That said, the ratio of products for overseas markets will increase in the future and there is a need to ensure a stable supply during emergencies. Therefore, we are considering manufacturing products and storing key intermediates at manufacturing sites overseas.

Ensuring Product Safety

Safety Monitoring System

Given that the safety evaluation carried out when a new product is approved is based on limited clinical trials, JCR continues to collect and evaluate safety and validity information on products after they have been manufactured and sold in accordance with a risk management plan (RMP). All the safety information collected is evaluated in a timely manner, and the need for implementing any additional safety measures is considered. Concurrently, JCR periodically evaluates the accumulated safety data and verifies whether there are any changes in trends such as side effects. If safety measures are necessary, JCR will convey information swiftly and reliably to all users that require it, such as medical professionals.
In order to implement these measures appropriately, JCR carries out safety management operations in accordance with laws and regulations. Notably, JCR provides regular training on the importance of collecting safety information to medical representatives (MRs), who directly interface with medical professionals, as well as the departments implementing safety management operations. This training is part of JCR’s efforts to improve the safety awareness vital to undertaking its corporate business activities.

System of Cooperation among Three Executives

In accordance with the Pharmaceuticals and Medical Devices Act, JCR has set up a system of cooperation among three executives, namely the Marketing Supervisor-General, Quality Assurance Manager and Safety Management Supervisor. This system is designed to scientifically evaluate the quality and safety of products independently of the Sales Division and Production Division, which are the principal agents of JCR’s corporate business activities. The system decides whether or not to implement product release, recall and safety measures, which are critical decisions for JCR. Through this independent governance system, JCR assures the quality and safety of its products.

Logistics Measures

Pharmaceutical logistics operations entail fulfilling supply obligations by delivering pharmaceuticals to distributors, wholesalers and medical institutions without delay, while maintaining pharmaceutical quality from the time of shipment from plants. As a pharmaceutical company without its own means of transporting products, JCR believes that it is crucial to build win-win relationships with carriers contracted to provide specialized transportation services for pharmaceuticals. Notably, JCR supplies pharmaceuticals for rare diseases, and it believes that the transportation of these pharmaceuticals presents issues such as the need for even higher-quality packaging methods and the development of transportation methods together with related contractors.
JCR works to grasp the conditions surrounding pharmaceutical logistics and to make daily improvements. In the process, JCR strives to achieve “seamless logistics” by establishing internally developed logistics standards, along with implementing logistics measures in compliance with Good Distribution Practice (GDP) guidelines.
Until now, JCR has realized packaging and delivery that permits temperature control suited to the characteristics of its products. For example, pharmaceuticals such as GROWJECT^® are packaged in Eco Thermostat Shuttle (ETS) boxes designed and developed in-house. TEMCELL^® HS Inj. is delivered and stored using an ultra-low cold chain system developed jointly with MEDIPAL HOLDINGS CORPORATION.
In April 2019, JCR endorsed the “White Logistics Movement” at an early stage. The “White Logistics Movement” is a national campaign to secure lasting and stable logistics operations. JCR makes the considerations necessary to ensure that compliance can be maintained with laws and regulations related to labor matters for transportation service contractors and the laws and regulations related to the motor truck transportation business. JCR also strives to reduce the waiting time for truck drivers during the loading or unloading of shipments by providing advance notice of arrival and shipment information.
In the past few years, drugmakers have been accelerating the outsourcing of their logistics operations to Third-Party Logistics (3PL) providers that own advanced temperature-controlled warehouses for pharmaceuticals. The drugmakers are taking this step to ensure distribution quality based on GDP guidelines. In response, the 3PL providers have been developing proprietary joint cold chain systems together with specialist pharmaceutical transportation service providers to enhance their transportation capabilities. Meanwhile, we have seen pharmaceutical wholesalers and distributors form an alliance with the 3PL providers to jointly reform the logistics chain from manufacturers to patients in a consistent manner.
Looking ahead, JCR also believes that transforming its logistics operations is an urgent priority for strengthening its global GDP response and BCP measures. Logistics operations could be transformed by, for example, outsourcing logistics operations to external contractors including 3PL providers.