论文部分内容阅读
可追溯性是FDA认证的核心。因此,打印控制系统使用的都是标准的部件和配置。这也就有可能实现在各个不同企业网络中的数据传输以及信息传递的无缝连接。医药产品生产属于具有高度责任意识和高度质量意识的行业领域。产品和产品质量从开始生产到包装出厂,乃至出厂使用若干年后都应该具有很好的可追溯性。作为这方面的相关技术规范,首先是各国颁布的相关法律法规,即包含了GMP(药品生产质量管理规范)和GAMP(优秀自动化制造规范)等内容的法律法规。作为执行机构,FDA(美国食品药品管理局)
Traceability is at the heart of FDA certification. Therefore, the print control system uses standard components and configurations. This also makes it possible to seamlessly transfer data and deliver information across different corporate networks. The production of pharmaceutical products belongs to the field of industry with a high sense of responsibility and a high degree of quality awareness. Product and product quality from the beginning of production to the packaging factory, and even after a few years of factory use should have good traceability. As the relevant technical specifications in this regard, the first is the relevant laws and regulations promulgated by various countries, including the laws and regulations of GMP (Good Manufacturing Practices) and GMP (Good Manufacturing Practices). As an implementing agency, FDA (US Food and Drug Administration)