Our quality management system

What is Ominedo’s quality management system?

Medical medicines(as mentioned above) are directly related to human lives and health, and their quality must be sufficiently guaranteed. This is why Ominedo is securing the utmost product quality through our compliance with the GMP (Good Manufacturing Practice) for medicines, the establishment of the quality assurance department, and preparation of new procedures in accordance with the GQP (Good Quality Practice). In addition, because Ominedo implements a full‐scale manufacturing system from the procurement of crude medicines to the delivery of the finished product, to integrate management of product quality and convey information through the chain can be done easily. We can also quickly and flexibly respond to our clients’ requests.

We can clearly grasp when, where, and how the crude medicine was cultivated and collected and who was in charge, with our local partners who manage the agricultural villages.
We also provide a cultivation guidance based on the strict pesticide standards for safer cultivation of crude medicines.

Crude medicines collected at each contracted farmer are shipped to a primary processing factory located in the area where our local partners are in charge for removal of foreign substances, cleansing, and drying.

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Primary sample test [to meet Ominedo’s specifications]
We collect crude medicine samples that have been processed, conduct ingredient and pesticide tests, and confirm the test results. Only the lot of products that have passed the sample tests will be transported to the secondary processing factory.

In the secondary processing factory jointly managed by our company, the crude medicines that were transported after passing the primary sample test will finally be processed in a form that matches the specifications defined by our company.

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Secondary sample tests [to meet the Japanese Pharmacopoeia and Ominedo’s specifications]
The quality tests specified by Ominedo (properties, quantitative test, heavy metal, arsenic test, microbial test and others) are performed, and only the products that pass our strict specifications will be exported to Japan.

We conduct an acceptance test for raw materials and materials including crude medicines to be used in the products. We repeatedly perform strict tests in accordance with the Japanese Pharmacopoeia and various official formularies, guarantee that the raw materials meet the specifications, and deliver safety and security to our clients.

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Final test [to meet the Japanese Pharmacopoeia and Ominedo’s specifications]
Inspection and sampling of imported crude medicines are performed, followed by a final test at our company. At this time, we secure a high level of safety of the materials by comparing the results of quality tests (1) and (2) as well as quality tests performed by our Chinese partners and the final test while constantly reviewing the quality test levels and the management system of processing, storage, and shipment of the materials of each partner.
Quality management in the manufacturing process is also an important responsibility we bear.

An “interim test” is performed for powdered extract/prepared extract.
Various tests for properties, color difference, weight, hardness, thickness, and collapsibility ensures that the quality of the product is consistent.
Then, a “product test” is performed when the finished product is made.
We confirm that the product meets the applicable specifications and immediately and accurately report the information back to each work site.

When manufacturing medical medicines that meet all specifications, both the in-process quality tests and the quality tests for the finished products play a vital role.
We evaluate the efficacy and safety of the product based on the results of the acceptance test, interim test, and final test.
We always make strictly objective judgements.
Samples of all raw materials/products released to the market are stored for a specified number of years. If there is any problem with the product, we can immediately check its counterpart sample. The samples are stored as reserve samples to confirm that they are the same as the products on the market.
For all products, tests are repeatedly conducted over time, guaranteeing that the products can be used safely within the usage period, which leads to being able to secure the safety of the product quality.

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