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動物医薬品検査所

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Quality assurance of VMPs

National Assay

Veterinary medicinal products (VMPs), especially veterinary biological products, must be subjected to national assays performed by an officer designated by the Minister. NVAL is the only national facility that performs tests of VMPs. The VMPs designated by the Minister shall not be sold or given, or stored or exhibited for the purpose of sale or giving, unless they satisfy the tests performed by NVAL. The rejected drugs are discarded in the presence of a pharmaceutical inspector.
National_assay.jpg(PDF)

Spot sampling test

For removing harmful drugs in the process of manufacturing and marketing, and ensuring quality, NVAL is performing quality assays of VMPs which were sampled by a pharmaceutical inspector at the manufacturer's factory or outlet. VMPs which do not meet the requirement of the tests performed by NVAL are collected and discarded.
Spot_samoling.jpg (PDF)

Quality tests by Order

The Minister may order that tests be performed for VMPs. Animal blood typing antibodies should also be tested. Rejected products are discarded in the presence of a pharmaceutical inspector.

Other Assays

Recently, a number of countries which have requested a certificate for the quality of products issued by the national facility has been increasing. As a result, NVAL performs necessary tests to Issue certificates.The NVAL also may perform quality tests upon the request from manufacturer (importer).
VMPs ,both manufactured and imported, have to be approved before they are sold in Japan. Biological products, such as vaccines, must pass “national assay”. Antibiotic products must pass an evaluation by order of the Minister of Agriculture, Forestry and Fisheries. Other drugs are also tested periodically to assure quality. If they are rejected in these assays and tests, they are subject to action, such as recall and disposal.
The NVAL is the only national laboratory to conduct assays and tests to assure the quality, efficacy and safety of VMPs.

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