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符合药品生产国际GMP的计量管理

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在药品生产过程中,为保证产品的质量,各工序的控制参数(特别是关键工艺参数)尤为重要.产品的工艺验证及设备的性能确认都是围绕产品的控制参数进行.也因此,对药品生产相关计量器具的管理是药品生产重要的一环.文章通过对比国内外GMP对计量管理的要求、仪表分级、接受标准和校准周期设定探讨符合国际GMP要求的计量管理实现方法,为药品生产企业的计量管理提供参考和借鉴.
Comply with the calibration management of international GMP for pharmaceutical production
In the process of drug production,in order to ensure the quality of products,the control pa-rameters of each process(especially for the critical process parameters)are particularly important.The process validation of the product and the performance qualification of the equipment are carried out around the control parameters of the product.Therefore,the management of measuring instruments relat-ed to drug production is an important part of drug production.This paper discusses the implementation method of calibration management in line with international GMP requirements by comparing the require-ments of GMP on calibration management,instrument classification,acceptance criteria and lifecycle setting,so as to provide reference for the calibration management of pharmaceutical manufacturers.

drug productionGMPcalibration management

王瑜

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国药集团致君(深圳)制药有限公司,广东 深圳 518109

药品生产 GMP 计量管理

2024

工业计量
冶金自动化研究设计院 中国计量协会

工业计量

影响因子:0.256
ISSN:1002-1183
年,卷(期):2024.34(5)
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