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目的建设规范化的消毒产品生产企业,以确保产品质量。方法通过规范硬件建设和管理制度的建立以及现场采样评价方法,对本企业规范化建设进行了评估。结果本企业新建或改建厂房布局和设备等硬件建设基本符合相关规范管理要求,获得相关部门验收通过并得到生产许可,所有上市产品均获得国家卫生部卫生许可批件。洁净车间内空气中细菌总数、悬浮粒子浓度、微小气候以及操作台表面和操作人员手细菌总数等指标均达到了相关规范要求。结论经过生产厂房、车间和环境重新规划和改建,制定出新的生产管理制度和操作规程,GMP车间达到了规范要求,其洁净度完全符合30万级洁净标准。
Purpose to build a standardized disinfection products manufacturing enterprises to ensure product quality. Methods By standardizing the establishment of hardware and management system and on-site sampling and evaluation methods, the standardization of this enterprise was evaluated. Results The hardware construction of plant layout and equipment of the newly built or rebuilt plant basically met the management requirements of relevant norms, passed the inspection and approval of the relevant departments and obtained the production license, and all the listed products obtained the approval documents of the Ministry of Health of the People’s Republic of China. The total amount of bacteria in the air, the concentration of suspended particulates, the microclimate and the total number of bacteria on the surface of the operating table and operator’s hands in the clean room reached the relevant specifications. Conclusions Through the re-planning and rebuilding of production plants, workshops and the environment, a new production management system and operating procedures have been formulated. The GMP workshop has met the regulatory requirements and its cleanliness fully meets the 300,000-level cleanliness standard.