Quality ManagementThe Foundation for Our Products

Quality Management

Bizen Chemical ensures that the required level of quality is achieved and maintained,
while striving to improve it.

• Raw materials

  

  Raw material inspection

• Pharmaceutical intermediates

  

  Process inspection

• Final product

  

  Product inspection

• After shipping

  

  Product sample inspection

Collection and storage of specimens

When accepting and managing raw materials, we check both the actual products and information on standards. We collect and store specimens from the inspection targets in each process at our factories, in accordance with regulations.

Inspection

We set the test methods and quality standards for each sample according to industry standards and agreements with our customers. Our expertly trained technicians use properly managed equipment and reagents to inspect each sample.

Management of inspection results

We take care to ensure that the raw data of inspection results and related documents are stored properly. We determine if the inspection results are in compliance with standards, and submit the results in an inspection report.

Quality Assurance

Bizen Chemical has introduced and operates systems for the management of quality and food safety.
We share customer feedback and other information throughout the company, and strive to maintain and improve peace of mind and satisfaction.

Management of our factories

We evaluate the available information to make a determination about which raw material to use. In addition, we perform internal audits to confirm that all production activities in our factories are carried out in accordance with standards, from the delivery of raw materials to the delivery of final products.

Training

We conduct regularly scheduled training in all departments throughout the company. We are always working to raise the level of quality company-wide, based on our expert knowledge of information related to quality, food safety, and other business-related matters.

Management of foreign matter and defective products

We manage foreign matter according to the required level of cleanliness in each production area (change of clothes, adhesive rollers, air showers, etc.). Depending on the production line, we have installed metal detectors, sieves, filters, and other necessary equipment. Defective products are detected and removed either by equipment or visual inspection.

Food defense

We believe that a relationship of trust between employees is of utmost importance, and therefore strive to maintain active communication. In addition, access to company premises by anyone who is not employed here is restricted. Furthermore, to prevent any breach of security, we implement preventive management that includes an entrance management system and surveillance cameras at the formulation and API factories.

Acquisition of Certifications

We have acquired certifications from a variety of organizations based on our policy of safety and security first.
We also deliver products of reliable quality to our customers overseas.

Health Food Products GMP

On November 9, 2005, we obtained Good Manufacturing Practice (GMP) certification for dietary supplements from the Japan Health and Nutrition Food Association.

ISO 9001

As of July 18, 2006, the Japanese subsidiary of the British Standards Institution (BSI) certified that our quality management system is being operated effectively.

FSSC 22000

On January 24, 2022, we obtained the FSSC 22000 international standard for food safety management systems certification from the Japanese subsidiary of the British Standards Institution (BSI).

EU-HACCP

As of March 1, 2011, we have obtained Ministry of Health, Labour and Welfare certification for facilities handling fish and fishery products to be exported to the EU.

FDA GMP in API Manufacturing

We have passed the GMP inspection for the manufacturing of API pharmaceutical intermediates by the US Food and Drug Administration (FDA).