| 摘要: |
| 通过对兽药产品批准文号情况进行统计分析，发现粉剂、散剂、最终灭菌注射剂等九大类生产剂型是目前我国最主要的中化药兽药产品生产剂型。为此，选择其中的粉剂、注射剂、中药提取生产剂型并对其所需关键生产、检验设备进行重点分析研究，以帮助企业选择适合的生产与检验设备以满足兽药GMP要求，同时也为兽医行政主管部门检查人员履行属地管理职责提供必要的参考。 |
| 关键词: 生产剂型 生产设备 检验设备 GMP 监督检查 |
| DOI： |
| 投稿时间：2020-08-05修订日期：2020-11-02 |
| 基金项目: |
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| Research on the Dosage Forms and Requirements of Key Production and Inspection Equipment for Veterinary Herbal Medicine and Drug in China |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| According to the statistical analysis of the approval number of veterinary drug products, nine types of production dosage forms, such as powder, pulvis and final sterilization injection, are found to be the most important productions of traditional Chinese medicine and chemical veterinary drugs in China. In this article, the key production and inspection equipment required for powder, injection and traditional Chinese medicine extraction are selected so as to help enterprises to select suitable pharmaceutical equipment for veterinary drug production and meet the requirements of GMP. At the same time, it can provide necessary reference for the inspectors of administrative department for veterinary to carry out supervision and inspection. |
| Key words: production dosage form production equipment inspection equipment GMP the supervision and inspection |
