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| 新版兽药GMP检查常见问题分析及改进建议 |
| 杨志昆,王艳玲,李有志,章安源,尹伶灵,门晓冬,冯涛,陈志强,陈玲 |
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| (山东省兽药质量检验所 济南 250012;山东省饲料兽药质量检验中心) |
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| 摘要: |
| 自2020年6月以来实施新版GMP验收标准，笔者对山东省验收兽药企业中发现的常见缺陷项，从质量管理、机构人员、厂房与设施、设备、物料与产品、确认与验证、文件管理、生产管理、质量控制与质量保证、产品销售与召回、自检共11个部分给予总结和归纳，对产生原因进行分析，提出改进建议，以期为兽药生产企业更好地实施GMP工作提供借鉴和参考。 |
| 关键词: 兽药生产质量管理规范 GMP规范 兽药GMP检查验收评定标准 |
| DOI： |
| 投稿时间：2022-09-18修订日期：2022-11-04 |
| 基金项目: |
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| Analysis of Common Problems in the Inspection of the New Version of Veterinary Drug GMP (revised in 2020) and Suggestions for Improvement |
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| (Shandong Provincial Qulity and Test Control Center of Veterinary drug) |
| Abstract: |
| Since June 2020, the new version of GMP acceptance standard has been implemented.The author summarized 11 common defects found in the acceptance of veterinary drug enterprises in Shandong Province including quality management、institutional personnel、 plants and facilities equipment、 materials and products、 confirmation and verification、 document management production management、 quality control and quality assurance、 product sales and recall、and self inspection、 and analyzed the causes、 Suggestions for improvement are pt forward to provide reference for veterinary drug manufacturers to better implement GMP. |
| Key words: Specification for quality management of veterinary drug production GMP specifications Evaluation standard for GMP inspection and acceptance of veterinary drugs |
