Sample Retention Management and Evaluation in Drug Inspection Agencies Based on Process- oriented Adminis- tration Concept / 中国药房

OBJECTIVE：To combine with the concept of process-oriented administration ，and to provide reference for improving the process and measures of the sample retention management and evaluation in drug inspection agencies. METHODS ： From the aspects of organizational management and control measures ，the improvement measures for sample retention management system were investigated. From the aspects of warehouse-in check ，storage management and warehouse-out judgment ，warehouse management and informatization ，the improvement measures for procedures and measures about sample retention management were explored. From the aspects of evaluation content and quality control measures ，the evaluation and continuous improvement of sample retention management were investigated. RESULTS & CONCLUSIONS ：In the aspect of organizational management ，it is necessary to improve management procedures and processes ，determine sample retention objectives and plans ，improve post allocation and management ，and improve safety emergency plans. In the aspect of control measures ，it is necessary to improve the business management measures such as warehouse-in status inspection ，adjust the conditions such as warehouse space allocation ， and improve the intelligent prompt of remaining validity period of samples. The key to the three links of warehouse-in ，storage and warehouse-out are warehouse-in check ，storage space and condition control ，and warehouse-out judgement. The relevant processes and measures can be improved from these aspects. The contents of sample retention management evaluation includes management system，management measures and process ，improvement and evaluation. Plan-Do-Check-Action （PDCA）cycle is a measure to improve the efficiency and quality of sample retention management in drug inspection agencies .

Construction Exploration of a Team of Professional Drug Inspectors in Hubei Province / 中国药师

Objective: To explore the ways to build a team of professional drug inspectors in Hubei province in oder to improve the quality and effectiveness of drug inspections in our province, reduce the risk of supervision, and ensure the safety of people's drug use. Methods: The requirements of national regulations and policies for the inspectors were interpreted, the construction system of profes-sional drug inspectors in Shanghai drug review and verification center was selected as comparison, the current situation and existing problems of the construction of drug inspectors in our province were analyzed, and the construction methods of professional inspectors in Hubei province were found out. Results: On the basis of the existing team of drug inspectors, a standardized system for selection, training, evaluation and grading of drug inspectors should be established, and the establishment of a team of professional drug inspec-tors in our province should be gradually completed. Conclusion: Our province can gradually establish a team of professional drug in-spectors, firstly from the current "main part-time assisted by full-time" to " lay equal stress on part-time and full-time", and then to"main full-time assisted by part-time", till the final realization of all professional drug inspectors.

Construction of Comprehensive Ability Evaluation Index System for Food and Drug Inspection and Testing Institutions in Guangxi Zhuang Autonomous Region / 中国药房

OBJECTIVE:To provide unified standard for assessing the comprehensive ability of food and drug inspection and testing institutions in Guangxi Zhuang autonomous region. METHODS:The comprehensive ability evaluation index system for food and drug inspection and testing institutions in Guangxi Zhuang autonomous region was drafted by literature review. Indexes of the evaluation index system were determined by Delphi expert consultation,and the weights were calculated by analytic hierarchy pro-cess (AHP). RESULTS:Literature review and expert consultation had constructed the comprehensive ability evaluation index sys-tem for food and drug inspection and testing institutions in Guangxi Zhuang autonomous region,including 6 first-level indexes,16 second-level indexes and 35 third-level indexes. AHP had determined the weights of indexes at all levels,and the weights of the 6 first-level indexes as basic conditions,management system,testing ability,work performance,scientific research and satisfaction degree,were respectively 0.1898,0.1233,0.2280,0.1915,0.1551 and 0.1124,in which testing ability held the highest weight. CONCLUSIONS:A set of scientific and suitable evaluating index system for food and drug inspection and testing institu-tions in Guangxi Zhuang autonomous region has been constructed,and the weights of indexes at all levels have been determined, which can provide clear and unified standard for conducting comprehensive ability system evaluation in each inspection and testing institution in Guangxi Zhuang autonomous region.

LIMS Upgrade and Verification Experience / 中国药师

Objective:To discuss the necessity of upgrade and verification laboratory information management system( LIMS) in drug control institutes. Methods:LIMS was upgraded and validated in a laboratory. Results:The upgrade and verification of LIMS en-sured the primitiveness and accuracy of laboratory date, and improved the work efficiency. Conclusion:The application of LIMS sys-tem ensures the reliability of the date and is of great significance to the development of drug testing organizations.

Problems and Countermeasures Existing in the Food and Drug Inspection and Testing System in Gansu Province / 中国药房

OBJECTIVE:To provide reference for improving the food and drug inspection and testing system in Gansu prov-ince. METHODS:The food and drug inspection and testing institutions in Gansu province were investigated by using questionnaires and interview. Information about resource allocation,operational capacity and business scope in various levels of food and drug in-spection and testing institutions in Gansu province were collected. Problems existing in food and drug inspection and testing system in Gansu province were analyzed,and countermeasures were put forward. RESULTS & CONCLUSIONS:The food and drug in-spection and testing system in Gansu province is not perfect,showing unreasonable resource allocation,lack of inspection and test-ing resources as a whole,low resource utilization,imperfect management mechanism,weak normativity and other problems. In or-der to achieve the improvement of food and drug inspection and testing system in Gansu province,countermeasures were put for-ward,including optimizing resource allocation of inspection and testing,enhancing facility and capacity,improving the utilization of existing resources,improving management mechanism,process and standard.

Thinking of Internal Audit in Drug Testing Laboratories / 中国药师

The internal audit is important for the management system of laboratory .The article stated how to effectively implement internal audit in drug testing laboratories in terms of the planning , checklist, pattern, problem observation , CAPA of non-compliance and application of results in internal audit .

Innovative thinking on the management of drug emergency inspection / 中国药学杂志

OBJECTIVE: To enhance the level of drug emergency inspection managements, and provide new ideas to deal with the drug incidents. METHODS: Firstly, the management courses of our drug emergency inspection were sorted out. Secondly, the solution ideas to the typical drug emergency incidents were analyzed. Thirdly, the relational experiences of developed countries were researched. RESULTS: The emergency management of our country had experienced from zero to full, and the responsible institution experienced from the point to surface. Although the emergency network had been basically established, each component was insufficient. We formulated a series of measures to strengthen the management with the analysis results on typical cases and the experiences of developed countries. CONCLUSION: A special solution idea and four innovative measures were made by a combination of theory and practice. The firstly, a whole system management plan was drawn up which could form a system cohesion and reverse the individual combat. The secondly, the technical plan was proposed which could provide the reasonable path to find reason. The thirdly, three effective measures were designed which could provide supplementary resources for management plan and technical plan. The fourthly, the government and enterprises strategies were suggested which could prevent from the source. In brief, our emergency management ability would be significantly enhanced by implementing the mentioned measures.

Study on Electronic Management for Drug Inspection Standards / 中国药师

Objective:To provide a new idea for the management of drug inspection standards. Methods: The current manage-ment mode for drug inspection standards was analyzed and studied, the problems and difficulties were summarized, and then a novel i-dea and method of electronic management was formulated. Results: The electronic management for drug inspection standards could solve the problems encountered in the traditional management effectively and improve the management efficiency. Conclusion: The standard management information system can provide drug inspection standards in time and ensure the effectiveness, which is very help-ful to the drug inspection.

Management of Drug Emergency Inspection / 中国药师

Objective:To enhance the management level of drug emergency inspection. Methods: The emergency inspection of plasticizers was used as the example, and the management in the whole inspection procedures was reviewed to summarize the difficulties and solutions and analyze the management features of drug emergency inspection. Results and Conclusion: There are three keys in successful drug emergency inspection, including correct top-level design, high efficient execution teams and necessary guarantee sys-tems.