Supplying reliable products is a constant challenge for people in the Pharmaceutical manufacturing industry. The production of medical supplies for life-threatening conditions particularly presents such challenges; so, we work toward supplying products more reliably by carrying out strict quality inspections which cover numerous steps from acceptance tests of materials to final product tests.
KAKETSUKEN has continued stable production with state-of-the-art plant facilities and production methods which comply with Good Manufacturing Practice (GMP) standards. The quality of products in each process is supported by the GMP system which is further supported by appropriate routine qualification tests. In the processes for concentrate-solution production and the filling and freeze-drying of plasma fractional products and vaccines, strict quality inspections are carried out in accordance with the Standards For Biological products. Animal , animal tests and other quality inspections developed by KAKETSUKEN have also been included in the in-house specification tests... Products that have passed the in-house tests mentioned above, and specifications tests conducted by the national authority, are packaged and released.
In addition, to guarantee QC activities and manufacturing control systems, an independent QA division is placed. In other words, the Quality Assurance division conducts internal audits on the departments in charge of development and production to check whether tasks have been regularly executed in accordance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and GMP. We consider it necessary to always judge things objectively so as to ensure the supply of superior products. We are convinced that such a consistent control system supports the development of superior products, which will in turn lead to a better reputation for KAKETSUKEN products.