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  • Yi-Fan ZHANG, Yu ZHANG
    Laboratory Testing. 2024, 2(1): 68-72.

    With the outbreak of the novel coronavirus in 2020, the demand and production of medical masks have shown a spurt of growth worldwide. In order to ensure the quality and safety of masks, countries around the world generally formulate testing standards for medical masks. This paper mainly compares and analyzes the detection standards of medical masks at home and abroad, and puts forward suggestions for the quality assurance and standard formulation of medical masks in China, which is of great significance to the field of public health.

  • Zhong-Fei HU
    Laboratory Testing. 2024, 2(1): 73-77.

    With the trend of globalization and population growth, the physical and chemical testing laboratories of disease control institutions play a crucial role in disease prevention and control. However, these laboratories face a series of safety and quality risks. The purpose of this study is to identify and control safety and quality risks in physical and chemical testing laboratories of disease control institutions. Through literature review and case studies, we analyzed the main risk sources in current laboratory management and proposed a series of measures to address these risks. This study has important guiding significance for improving the safety and quality of physical and chemical testing laboratories in disease control institutions.

  • Liang JIA
    Laboratory Testing. 2024, 2(1): 78-82.

    Compared with most of the current published instruments and equipment management risk research literature, generally only pay attention to the risk identification of individual links, and there are problems such as incomplete risk identification and analysis, which will affect the effectiveness of instrument and equipment risk management. In order to guide the inspection body and laboratory to carry out the risk management of instruments and equipment more reasonably, risk identification is carried out from the aspects of the whole life cycle and safety of instruments and equipment, and the identified risks are analyzed and evaluated, and risk disposal suggestions are put forward according to the evaluation results. Encourage inspection body and laboratory to always meet the requirements of management system and compliance operation in terms of instrument and equipment risk management.

  • Liang JIA
    Laboratory Testing. 2024, 2(1): 79-82.

    Compared with most of the current published instruments and equipment management risk research literature, generally only pay attention to the risk identification of individual links, and there are problems such as incomplete risk identification and analysis, which will affect the effectiveness of instrument and equipment risk management. In order to guide the inspection body and laboratory to carry out the risk management of instruments and equipment more reasonably, risk identification is carried out from the aspects of the whole life cycle and safety of instruments and equipment, and the identified risks are analyzed and evaluated, and risk disposal suggestions are put forward according to the evaluation results. Encourage inspection body and laboratory to always meet the requirements of management system and compliance operation in terms of instrument and equipment risk management.

  • Rui ZHANG
    Laboratory Testing. 2024, 2(1): 83-87.

    As the most basic medical means, drugs can not only effectively treat and prevent diseases, but also directly affect the health of users. With the continuous improvement of the number and output of drugs, the quality and safety of drugs are the core tasks of pharmaceutical enterprises that can not be ignored. As an important means to detect the risk of problems, the effect of inspection and detection is affected by many factors, such as personnel, equipment, environment and so on. For this, major pharmaceutical manufacturing enterprises have the obligation to perform their duties and strengthen drug quality detection. In the context of the rapid development of science and technology, automation technology, information sharing platform, real-time monitoring system and so on have provided strong support for the development of drug inspection. Data integrity runs through the whole process of drug inspection. It is an internal demand and an inevitable trend to pay attention to the construction of drug research and development laboratory information management system (LIMS). Based on this, starting from the background of drug research and development stage, this paper explores the construction and design content of drug inspection LIMS, and puts forward corresponding construction strategies on how to improve the quality management level of drug research and development, in order to provide exchange and reference.

  • Jia-Jia ZHOU
    Laboratory Testing. 2024, 2(1): 88-93.

    In this paper, the equipment management, personnel training and quality control of the laboratory are comprehensively assessed by adopting quality control methods such as checklist evaluation and traceability management. Taking a food testing laboratory as an example, it quantitatively analyzes its quality management and gives the evaluation and improvement suggestions on equipment management, personnel training and quality control of the laboratory. Meanwhile, in the process of establishing a traceable management system, the management of quality control should also be strengthened to improve the accuracy and reliability of testing. Through the improvement and refinement of the laboratory, it can not only enhance the overall quality level of the testing laboratory, but also contribute to the maintenance of social public safety and health.

  • Jia-Jia ZHOU
    Laboratory Testing. 2024, 2(1): 89-93.

    In this paper, the equipment management, personnel training and quality control of the laboratory are comprehensively assessed by adopting quality control methods such as checklist evaluation and traceability management. Taking a food testing laboratory as an example, it quantitatively analyzes its quality management and gives the evaluation and improvement suggestions on equipment management, personnel training and quality control of the laboratory. Meanwhile, in the process of establishing a traceable management system, the management of quality control should also be strengthened to improve the accuracy and reliability of testing. Through the improvement and refinement of the laboratory, it can not only enhance the overall quality level of the testing laboratory, but also contribute to the maintenance of social public safety and health.

  • Hai-Hong LIU, Ruo-Chun CAI, Qing Liang, Li-Hua LE, Hai-Ying ZHONG, Yi LEI
    Laboratory Testing. 2024, 2(1): 94-100.

    Objective Deeply dig into the rapid inspection data, build a quality evaluation model for food rapid inspection work, and achieve targeted management and smart supervision of rapid inspection work. Methods Based on massive rapid inspection data, the current status and supervision model of food rapid inspection in farmers' markets were analyzed, and a quality evaluation model for rapid food inspection was constructed. Results By carrying out research on the big data system for food rapid inspection, improving the scientificity and effectiveness of the evaluation of rapid inspection work. Conclusion This study provides a scientific theoretical basis for accurate supervision, intelligent supervision and targeted supervision at the grass-roots level.

  • Yu-Xin SHI, Jia-Xing GUAN, Bo-Hua ZOU, Xia-Yang WANG, Le QIN
    Laboratory Testing. 2024, 2(1): 101-106.

    In order to solve the problems of significant increase in workload, cumbersome management work, duplication of materials and low review efficiency caused by the increase of open subject application year-by-year, this article elaborates and analyzes the various needs in the open project management process, based on the requirements of the project-oriented management system, and the laboratory open subject management system was constructed based on the requirements of subject management system. The system is developed based on SpringBoot microservice architecture, B/S(Browser/Server) architecture, and Java language development. It can complete project demand reporting, requirements review, requirements selection, project application collection, project application review, project project initiation, mid-term inspection results management, and final inspection, and realize the information management of the whole life cycle of laboratory open projects.

  • Xiao-Hong DENG, Guo-Wei ZHONG, Yin YAN
    Laboratory Testing. 2024, 2(1): 107-111.

    Food inspection and testing institutions need to obtain corresponding qualification recognition in order to provide verifiable data results to society. Familiarity with the CMA qualification recognition and review process is a condition for the normal operation of food inspection and testing institutions. This article is based on the requirements outlined in RB/T214-2017, RB/T215-2017, and related norms and testing standards. Using the example of the on-site assessment of the CMA qualification extension for the food testing laboratory at the Zhenjiang Food and Drug Supervision Inspection Center, this article conducts an analysis of non-conformities and proposes targeted improvements. Additionally, it summarizes some experiences and reflections in areas such as personnel, instrumentation, system documentation, environmental facilities, and method validation. These insights are intended to serve as a reference for relevant personnel and laboratories in their pursuit of normal operations and conducting CMA qualification assessment reviews.