| 中药饮片储存管理规范？ |
| 添加时间：2017/8/16 15:06:17 浏览次数： |
| （1）为加强中药饮片经营管理，确保科学、合理、安全、准确地经营中药饮片，杜绝销售假药、劣药，根据《药品管理法》及《药品经营质量管理规范》制定本制度。 (1) to strengthen Chinese medicine yinpian management, to ensure the scientific, reasonable, safe and accurate operation and Chinese medicine yinpian, put an end to selling fake medicines and medicines of inferior quality, according to the drug administration law and the drugs management quality management standard system are formulated. （2）中药饮片购进管理： (2) purchase and management of Chinese medicines: ①所购中药饮片必须是合法生产企业生产的合法药品； (1) the Chinese medicine and beverage purchased by the company must be the legal medicine produced by the legitimate production enterprise; ②所购中药饮片应有包装，包装上应有品名、规格、生产企业、生产日期，实施批准文号管理的中药饮片还应有药品批准文号和生产批号； (2) the purchased Chinese medicine yinpian due and packaging, should be on the package name, specifications, production enterprise, production date, the approval document for the implementation of the management of traditional Chinese medicine yinpian and an approval number shall also have the production batch number; ③购进进口中药饮片应有加盖供货单位质量管理机构原印章的《进口药材批件》及《进口药材检验报告书》复印件； The imported traditional Chinese medicine and drink tablets should be stamped with the original seal of the quality management agency of the supply unit and the copy of the inspection report of imported materials. ④该炮制而未炮制的中药饮片不得购入。 No Chinese traditional Chinese medicine can be purchased. （3）中药饮片验收管理； (3) acceptance management of Chinese medicines; ①验收员应按照法定标准和合同规定的质量条款对购进的中药饮片进行逐批验收； The inspection staff shall, in accordance with the legal standards and the quality terms stipulated in the contract, carry out the batch acceptance of the purchased Chinese medicinal products. ②验收时应同时对中药饮片的包装、标签及有关要求的证明或文件进行逐一检查； The packaging, labelling of Chinese traditional Chinese medicine and the relevant requirements or documents shall be examined at the same time. ③验收应按照规定的方法进行抽样检查； The acceptance shall conduct sampling inspection according to the prescribed method; ④验收应按规定做好验收记录，记载供货单位、数量、到货日期、品名、规格、生产厂商、生产日期、质量状况、验收结论和验收人员等项内容；实施批准文号管理的中药饮片还应记载药品的批准文号和生产批号； (4) acceptance shall be in accordance with the provisions, completes the inspection record, record supply unit, quantity, delivery date, name, specification, manufacturer, production date, quality status and acceptance conclusion and acceptance and so on a content; The approval number and batch number of the drug should also be recorded in the Chinese traditional Chinese medicine. ⑤验收记录应保存至超过药品有效期一年，但不得少于二年； The acceptance record shall be kept for one year, but not less than two years; ⑥对特殊管理的中药饮片，应实行双人验收制度。 The double acceptance system should be implemented for the special management of traditional Chinese medicine. |
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