| 祁洋洋.我国原料药企业在接受国外客户GMP审计中存在的问题和对策[J].中国药事,2021,35(6):641-645 |
| 我国原料药企业在接受国外客户GMP审计中存在的问题和对策 |
| Problems of Chinese API Manufacturers in Foreign Customers’ GMP Audit and the Countermeasures |
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| DOI：10.16153/j.1002-7777.2021.06.005 |
| 中文关键词: 原料药 质量审计 GMP 国外客户 |
| 英文关键词: API quality audit GMP foreign clients |
| 基金项目: |
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| 摘要点击次数: 926 |
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| 中文摘要: |
| 目的：分析国外客户对我国原料药生产企业质量审计过程中所关注的重点内容，总结我国原料药生产企业在客户质量审计中存在的问题，提出解决这些问题的方法，为原料药生产企业积极应对国外客户审计提供有价值的建议。方法：以我国某原料药生产企业接受国外客户GMP审计为例，分析该企业在客户质量审计中存在的问题，对问题剖析后提出相应的解决措施和建议。结果与结论：该原料药生产企业在国外客户质量审计中涉及的缺陷项目主要分布在质量管理、物料管理、工艺设备、厂房与设施、文件、生产管理和验证等方面。企业应当加强自检，积极参与国外监管机构GMP认证工作，从而不断提高自身质量管理水平。 |
| 英文摘要: |
| Objective: To analyze the key contents that foreign customers are most concerned about during the quality audit of API manufacturers, summarize the problems existing in the customer quality audit of Chinese API manufacturers and put up with the solutions for the problems in order to provide valuable suggestions for API manufacturers to actively respond to audit of foreign clients. Methods: To take the GMP audit from foreign customers of an API manufacturer in China as an example, the problems existing in the customer quality audits of the enterprise were analyzed, and the corresponding solutions and suggestions were put forward after analyzing the problems. Results and Conclusion: The defective items involved in foreign customer quality audits of the API manufacturer mainly lay in quality management, material management, process equipment, workshop buildings and facilities, documentation, production management validation, etc. The enterprises should strengthen self-inspection and actively participate in GMP certifications of foreign regulatory agencies, so as to continuously improve their own quality management level. |
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