Production and Quality Assurance

Pharmaceuticals are products that directly affect human lives. At a pharmaceutical company, quality is the responsibility of the company as well as every employee. Without robust quality and compliance, we cannot retain the trust of patients, healthcare professionals, national regulatory authorities nor that of society. Kyowa Kirin’s Global QA Function is responsible for confirming that all processes involved in the production of products and investigational drugs are conducted properly and in compliance with relevant laws and regulations. In this way, the function fulfills its role of ensuring that there are no problems with the quality of the drugs delivered to patients.

Kyowa Kirin uses an eQMS (enterprise/electronic quality management system) globally. This system covers a wide range of quality assurance operations including change management, deviation control, corrective action/preventive action (CAPA), training, document management, auditing and supplier management by means of a complete electronic process. We now have in place a platform that enables us to meet a globally consistent standard as well as the requirements of relevant laws and regulations in each country.

We achieve rapid market launch and stable supply of high-quality products throughout their lifecycle, from the development stage to post-market launch. Also, we will continue to deliver high-quality products by continuing to address drug fostering and evolution and research and development of new technologies. To achieve this, we work closely with various functions, including those involved in production technology development, manufacturing, analytical technology research and manufacturing approval applications, in order to take on the challenge of developing high-quality pharmaceuticals.

As biopharmaceuticals are heterogeneous molecules, outstanding technologies are required to control their quality. Kyowa Kirin uses production and analytical technologies accumulated since it started the production of erythropoietin to produce and supply many biopharmaceuticals, including antibody drugs. In recent years, in addition to developing biopharmaceuticals that utilize our unique antibody technologies and protein engineering, we have developed new technologies such as single-use technology and continuous manufacturing technology aimed at making our plants even more productive.

In the manufacturing of active pharmaceutical ingredients for small molecule drugs, we not only pursue high-quality, but also explore highly efficient synthesis routes and build manufacturing processes. During the production stage, dosage forms which are most suitable for patients are selected and raw materials and manufacturing conditions are optimized to further improve the quality of the formulation. In addition, we are committed to contributing to patients and people who support them by applying formulation technologies that add value such as ease of administration and handling (such as orally disintegrating tablets, bitterness masking, dividable tablets and granules and dry syrups for children) and utilizing formulation technologies that maximize the value of drugs (such as dissolution control technology, solubility improvement technology, and targeting technology).