主な検査業務 Major Testing Services
- 薬機法第43条に基づく検査 Official Verification
- 収去検査 Market Surveillance Testing
- 検査命令による品質検査 Mandatory Quality Testing
- その他の依頼検査 Testing Services for Export Certification
薬機法第43条に基づく検査
動物用医薬品のうち、特に生物学的製剤は、農林水産大臣が指定する者による検査を受けることが義務付けられています。当所はこの検査を実施する我が国唯一の指定機関です。検査対象となる動物用医薬品は、当所の検査に適合したものでなければ、販売し、授与し、又は販売若しくは授与の目的で貯蔵し、若しくは陳列することができません。検査不合格の場合は、薬事監視員の立会いのもとで廃棄処分されます。
Official Verification (National Batch Release Testing)
Veterinary medical products (VMPs), especially veterinary biological products, are required to undergo official verification conducted by an institution designated by the Minister of Agriculture, Forestry and Fisheries. NVAL is the only laboratory designated to conduct such official verification in Japan.
VMPs subject to official verification may not be sold or supplied, or stored or displayed for the purpose of sale or supply, unless they comply with the requirements of the official verification conducted by NVAL. Products that fail the official verification are disposed of under the supervision of a pharmaceutical inspector.
収去検査
動物用医薬品の製造、流通過程における品質確保及ぴ不良薬品の排除を図るため、製造業者の製造所、販売業者の店舗において薬事監視員により収去された製品について品質確認検査を行っています。検査不合格の場合は、農林水産大臣の命令に基づく不合格品の回収、廃棄が行われます。
Market Surveillance Testing
To ensure the quality of veterinary medical products distributed in the marketplace and to eliminate substandard products, NVAL conducts quality testing of samples collected by pharmaceutical inspectors from manufacturing facilities and marketing premises.
When a product fails to meet the applicable quality requirements, regulatory measures, including recall and disposal, are taken in accordance with an order issued by the Minister of Agriculture, Forestry and Fisheries.
検査命令による品質検査
動物用医薬品については、農林水産大臣が必要と認めるときに検査が課されます。血液型判定用抗体診断薬については、新たに製造承認された一定ロットは検査命令の対象となり、品質確保検査が行われます。不合格の場合は収去品と同様の措置がとられます。
Mandatory Quality Testing
Veterinary medical products may be required to undergo testing when the Minister of Agriculture, Forestry and Fisheries finds it necessary. Certain lots of newly approved animal blood typing reagents are subject to mandatory quality testing under an order for testing to ensure their quality. Products that fail to meet the prescribed requirements are subject to the same measures as products that fail market surveillance testing.
その他の検査依頼
最近、特定の国において、我が国の公的機関が発行する品質に係わる証明書の提示が要求されるケースが増加していることから、輸出用動物用医薬品についての検査成績書発行に必要な検査等を実施しています。
Testing Services for Export Certification
As an increasing number of countries require the submission of quality certificates issued by the competent government authority of Japan, NVAL conducts tests and other necessary examinations required for the issuance of test reports and related certificates for veterinary medical products intended for export.
