| 夏栋栋.GLP体系下对实验动物供应商审核的要求[J].中国药事,2018,32(9):1271-1273 |
| GLP体系下对实验动物供应商审核的要求 |
| Audit Requirement for Experimental Animal Suppliers in GLP System |
| 投稿时间：2017-07-22 |
| DOI：10.16153/j.1002-7777.2018.09.019 |
| 中文关键词: 药物非临床研究质量管理规范 实验动物 供应商审核 审核流程 |
| 英文关键词: GLP for nonclinical studies of drugs experimental animal supplier audit audit process |
| 基金项目: |
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| 摘要点击次数: 1381 |
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| 中文摘要: |
| 目的：规范实验动物供应商管理。方法：依据《药物非临床研究质量管理规范》（GLP）等相关法规要求，对实验动物供应商审核相关流程和要求进行了论述。结果与结论：实验动物在药物安全性评价中占有极其重要的地位。通过规范实验动物供应商审核流程，加强动物来源控制，可以有效地提高药物非临床原始资料的有效性和真实性，充分发挥GLP体系下实验动物供应商审核的优越性，保证非临床研究水平。 |
| 英文摘要: |
| Objective: To standardize management of experimental animal suppliers.Methods: According to requirements of good laboratory practice (GLP) for nonclinical studies of drugs and other relevant laws and regulations, the audit process and requirements for experimental animal suppliers were described.Results and Conclusion: Experimental animals play an important role in safety evaluation of drugs. The validity and authenticity of nonclinical data of drugs can be effectively improved by standardizing the audit process of experimental animal suppliers and strengthening the control of animal sources. The advantages of the audit of experimental animal suppliers in GLP system should be utilized to ensure the level of non-clinical studies. |
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