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How to fill in sampling records and vouchers
Drug supervision and management personnel conduct targeted sampling tests on suspicious drugs in the process of daily supervision and law enforcement, and the drug sampling records and vouchers filled in on the spot are of great significance for investigating cases in the future. Therefore, the filling of sampling records and vouchers must be standardized and rigorous. Br> 1. Name: The generic name (legal name) of the drug should be filled in according to the name on the drug package, not the trade name or trademark plus the generic name. The legal name of imported drugs shall be filled in according to the name on the Registration Certificate of Imported Drugs issued by the State Food and Drug Administration of the United States. Chinese herbal medicines (decoction pieces) should fill in the name used in the drug standard, and may not fill in the common name; If it is a processed product, it should be noted, such as roasted licorice, vinegar Schisandra chinensis, salted dodder, etc. , or "Radix Polygoni Multiflori Preparata, Radix Aconiti Preparata, etc." to facilitate inspection. 2. Batch number: fill in according to the production batch number on the drug package, not the production date. If there is no Chinese herbal medicine batch number, fill in "/". 3. Drug instructions: The preparation instructions should be filled in according to the "specifications" of drug quality standards, not written as the packaging specifications of drugs. 4. Validity period: it should be filled in according to the validity period marked on the drug package. The validity period of some hospital preparations should not be filled in as "××× year × month × day × month × day × month × day × month × day × month × day × month × day × month × day × month × day × month × day × month × day × month × day × day × month × day × month × day × month × day × month × day × month × day × month × month × day × month × month × month "Place of origin" is only applicable to Chinese herbal medicines (decoction pieces), and the place of origin or final processing (production) should be filled in; In practical work, most Chinese herbal medicine distribution units are filled in. It should be noted that the contents filled in should be consistent with the contents recorded in the relevant certificates such as purchase invoices or contracts and transfer orders. 6. Sample supplier (sampled unit): fill in the full name of the sampled pharmaceutical production enterprise, trading enterprise or medical institution, and check it with the name stamped with the official seal on the certificate and the name on the Pharmaceutical Production (Trading) License to ensure consistency. 7. Sampling quantity (inspection quantity): fill in by multiplying the packaging quantity of the sampled sample by the original packaging specifications, and do not insert specifications into the quantity; The last quantity filled in is the minimum unit quantity of drugs, that is, the total quantity of drugs (granules, branches and tablets) extracted. If a certain amount of raw materials or Chinese herbal medicines (decoction pieces) are extracted from the original packaging, the specific extraction weight can be filled in and "packaging" can be added. 8. Sample packaging: the material of the smallest original packaging container for extracting drugs should be filled in, in which the packaging of raw materials and Chinese herbal medicines (decoction pieces) refers to the packaging container that is in direct contact with the sample. 9. Quantity of production, preparation or purchase: it should be clearly filled in according to production records such as feeding and preparation, purchase invoices and other evidence, and generally "×× boxes" and "×× pieces" should not be filled in. 10. Address of the sampled unit: In addition to the accurate and complete address, the postal code and other contents should be filled in for mailing the inspection report. 1 1. Description of sampling inspection: that is, the purpose of inspection. Specific contents such as national plan sampling inspection, provincial plan evaluation sampling inspection, supervision sampling inspection and follow-up sampling inspection should be filled in to reflect the purpose and pertinence of this sampling inspection. Jiangxi Nanchang Institute for Drug Inspection Huang (Huang)