| 滕贇,刘雅丹,崔黎,韩峰,王恺,常艳.建设满足数据完整性要求的药品微生物检测实验室路径探析[J].中国药事,2024,38(6):617-626 |
| 建设满足数据完整性要求的药品微生物检测实验室路径探析 |
| Construction of Pharmaceutical Microbial Testing Laboratory with Alignmentof Data Integrity Requirements |
| 投稿时间：2024-03-16 |
| DOI：10.16153/j.1002-7777.2024.06.002 |
| 中文关键词: 药品微生物检测 数据完整性 智慧化管理 实验室认可 |
| 英文关键词: pharmaceutical microbial testing data integrity intelligent management laboratory accreditation |
| 基金项目:南通市科技项目地产特色中药品种晕可平颗粒微生物安全保障体系的建立（编号 MS22022027） |
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| 中文摘要: |
| 目的：分析现有药品领域微生物检测实验室管理模式中存在的问题，有针对性地提出满足数据完整性要求的药品微生物检测实验室的运行方式。方法：梳理法律法规、检测标准、行业规范及实验室认可规则、认可准则及相关应用说明中涉及微生物实验室的基本管理要求；归纳总结当前国内微生物检测实验室中实际存在的多发性问题；尝试分析现有运行模式中可能存在的管理弊端。结果与结论：在满足法律法规、行业标准及认可基本要求的前提下，探讨了使用智慧化方式建设满足数据完整性要求的药品微生物检测实验室的方式，为行业实验室建设提出合理化建议。 |
| 英文摘要: |
| Objective: To analyze the problems existing in the management mode of pharmaceutical microbialtesting laboratories, and put forward the operation mode of pharmaceutical microbial testing laboratories to meetthe requirements of data integrity. Methods: The basic management requirements of microbial laboratories inlaws and regulations, testing standards, industry norms and laboratory accreditation rules, accreditation standardsand related application instructions were sorted out. The multiple problems in microbial testing laboratories inChina were summarized. The possible management disadvantages in the existing operation mode were tried toanalyze. Results and Conclusion: Under the premise of meeting the basic requirements of laws and regulations,industry standards and accreditation, this article discusses the use of intelligent way to construct pharmaceuticalmicrobial testing laboratories that meets data integrity requirements, and puts forward reasonable suggestions forthe construction of industrial laboratory. |
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