QUALITY CONTROL

Through advanced and severe quality control, we provide secure, reliable and high quality medical pharmaceutical products.

In compliance with the latest GMP (Good Manufacturing Practice), our quality control department executes severe quality control independently from our manufacturing department.

The quality control ranges from acceptance test for drug substance, auxiliary materials and other materials, in-process examination in production process, to final examination before shipping for finished products.

In diversified social situations and globalization, attention to ‘quality’ has been increasing year after year.
As Japan has joined the global standard, PIC/S (the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme) in 2014, we are promoting to comply with PIC/S.

We have set up a microbial lab for microbiological tests as well as a bioclean lab for sterilization test of sterile products.
Also, homeostasis specimen storeroom capable to comply with a global standard is established. Our quality control executes not only testing and examination by advanced analytical instruments, but also clear-cut lot management system in production process.

As quality control commitment, we carry out CAPA (corrective and preventive action) and focus on factory employees’ education.

Moreover, in order to assure after-sale ‘quality’, we have established Quality Assurance Department and Safety Management Department so that we can pursue our mission to provide high-quality and safe pharmaceutical products through broad information collection.

High-performance liquid chromatography
High-performance liquid chromatography
Physics and chemistry test
Physics and chemistry test
Gas chromatography
Gas chromatography
Microbial test
Microbial test

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