{"id":3862,"date":"2017-09-26T10:32:32","date_gmt":"2017-09-26T01:32:32","guid":{"rendered":"https:\/\/hcv1004zroqo.smartrelease.jp\/mg\/?page_id=3862"},"modified":"2019-01-11T13:40:58","modified_gmt":"2019-01-11T04:40:58","slug":"quality","status":"publish","type":"page","link":"https:\/\/www.ominedo.co.jp\/en\/quality\/","title":{"rendered":"Our quality management system"},"content":{"rendered":"

What is Ominedo\u2019s quality management system?<\/h2>\n

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
\nthrough our compliance with the GMP (Good Manufacturing Practice) for medicines, the
\nestablishment of the quality assurance department, and preparation of new procedures
\nin accordance with the GQP (Good Quality Practice). In addition, because Ominedo implements a full\u2010scale
\nmanufacturing 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\u2019 requests.<\/p>\n

\n
\n
\n
\"\"<\/dt>\n
We can clearly grasp when, where, and how the crude medicine was cultivated and collected
\nand who was in charge, with our local partners who manage the agricultural villages.
\nWe also provide a cultivation guidance based on the strict pesticide standards for
\nsafer cultivation of crude medicines.<\/dd>\n<\/dl>\n
\n

\"\"<\/h3>\n

Crude medicines collected at each contracted farmer are shipped to a primary processing
\nfactory located in the area where our local partners are in charge for removal of foreign
\nsubstances, cleansing, and drying.<\/p>\n

\n
\"\"
\nClick here for main examples of quality tests ><\/a><\/dt>\n
\n
\n
Primary sample test [to meet Ominedo\u2019s specifications]<\/dt>\n
We collect crude medicine samples that have been processed, conduct ingredient and
\npesticide tests, and confirm the test results. Only the lot of products that have passed
\nthe sample tests will be transported to the secondary processing factory.<\/dd>\n<\/dl>\n<\/dd>\n<\/dl>\n<\/div>\n
\n

\"\"<\/h3>\n

In the secondary processing factory jointly managed by our company, the crude medicines
\nthat were transported after passing the primary sample test will finally be processed in
\na form that matches the specifications defined by our company.<\/p>\n

\n
\"\"
\nClick here for main examples of quality tests ><\/a><\/dt>\n
\n
\n
Secondary sample tests [to meet the Japanese Pharmacopoeia and Ominedo\u2019s
\nspecifications]<\/dt>\n
\"\"The quality tests specified by Ominedo (properties, quantitative test, heavy metal,
\narsenic test, microbial test and others) are performed, and only the products that
\npass our strict specifications will be exported to Japan.<\/dd>\n<\/dl>\n<\/dd>\n<\/dl>\n<\/div>\n

\"\"<\/p>\n<\/div>\n

<\/p>\n

\n
\n
\"\"<\/dt>\n
We conduct an acceptance test for raw materials and materials including crude medicines to
\nbe used in the products. We repeatedly perform strict tests in accordance with the
\nJapanese Pharmacopoeia and various official formularies, guarantee that the raw
\nmaterials meet the specifications, and deliver safety and security to our clients.<\/dd>\n<\/dl>\n
\n
\n
\"\"
\nClick here for main examples of quality tests ><\/a><\/dt>\n
\n
\n
Final test [to meet the Japanese Pharmacopoeia and Ominedo\u2019s specifications]<\/dt>\n
\"\"Inspection and sampling of imported crude medicines are performed, followed by a final
\ntest at our company. At this time, we secure a high level of safety of the materials
\nby comparing the results of quality tests (1) and (2) as well as quality tests
\nperformed by our Chinese partners and the final test while constantly reviewing
\nthe quality test levels and the management system of processing, storage, and
\nshipment of the materials of each partner.<\/dd>\n<\/dl>\n<\/dd>\n<\/dl>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n
\"\"<\/dt>\n
\"\"Quality management in the manufacturing process is also an important responsibility
\nwe bear.<\/p>\n

An \u201cinterim test\u201d is performed for powdered extract\/prepared extract.
\nVarious tests for properties, color difference, weight, hardness, thickness, and
\ncollapsibility ensures that the quality of the product is consistent.
\nThen, a \u201cproduct test\u201d is performed when the finished product is made.
\nWe confirm that the product meets the applicable specifications and immediately and
\naccurately report the information back to each work site.<\/p>\n

When manufacturing medical medicines that meet all specifications, both the in-process
\nquality tests and the quality tests for the finished products play a vital role.<\/dd>\n<\/dl>\n<\/div>\n

<\/p>\n

\n
\n
\"\"<\/dt>\n
We evaluate the efficacy and safety of the product based on the results of the
\nacceptance test, interim test, and final test.
\n
We always make strictly objective judgements.<\/dd>\n<\/dl>\n
\n
\"\"<\/dt>\n
\"\"Samples of all raw materials\/products released to the market are stored for a
\nspecified number of years. If there is any problem with the product, we can
\nimmediately check its counterpart sample. The samples are stored as reserve
\nsamples to confirm that they are the same as the products on the market.<\/dd>\n<\/dl>\n
\n
\"\"<\/dt>\n
For all products, tests are repeatedly conducted over time, guaranteeing that the
\nproducts can be used safely within the usage period, which leads to being able to
\nsecure the safety of the product quality.<\/dd>\n<\/dl>\n<\/div>\n

<\/p>\n<\/div>\n

<\/p>\n

Click here for main examples of quality tests<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

What is Ominedo\u2019s 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\u2010scale 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 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":8,"comment_status":"open","ping_status":"open","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3862","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3862","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/comments?post=3862"}],"version-history":[{"count":10,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3862\/revisions"}],"predecessor-version":[{"id":4113,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3862\/revisions\/4113"}],"wp:attachment":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/media?parent=3862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}