Chiyoda has executed the engineering, procurement, construction and validation (EPCV) work of a state-of-the-art plant for injectable drugs for CMIC CMO Co., Ltd., a wholly owned subsidiary of CMIC HOLDINGS Co., Ltd.
This plant is capable to manufacture the injectable drugs derived from biotechnological process such as antibody drugs, and also from high potent active ingredients used for new anticancer drug to the growing market. This is a leading edge facility that is compliant with PIC/S*1 and trilateral GMP (Japan, Europe, USA)*2, and is designed to realize highly sterility assurance level of the production by effective and rational room layout.
Chiyoda has supported the CMO*3 business developed by CMIC HOLDINGS Co., Ltd. with the construction of this injectable drug plant.
- 1：PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme): An international framework to promote the formulation of common manufacturing and quality control standards and mutual inspection in the area of pharmaceuticals. Japan joined PIC/S in July 2014.
- 2：Trilateral GMP : Standards for the manufacturing and quality control of pharmaceuticals established in three regions (Japan: the Ministry of Health, Labor and Welfare, the United States: the FDA and Europe: the EMA)
- 3：CMO (Contract Manufacturing Organization): A company that undertakes comprehensive services, such as drug manufacturing, from pharmaceutical companies. In April 2005, the revised Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was enacted. The revised pharmaceutical approval and license system allows approval of manufacturing and sales similar to Europe and the United States. Since then, a non-pharmaceutical company is able to undertake the overall pharmaceutical manufacturing processes.