亚洲社会药学
亚洲社会药学

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亚洲社会药学

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Construction of Competency Model of Drug GMP Inspectors

Zhao Zhenyu 1,2, Wu Zhi’ang 1*   

  1. 1.School?of?Business?Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.China Food and Drug Administration, Beijing 102300, China
  • 出版日期:2017-10-20 发布日期:2017-11-23

Construction of Competency Model of Drug GMP Inspectors

Zhao Zhenyu 1,2, Wu Zhi’ang 1*   

  1. 1.School?of?Business?Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.China Food and Drug Administration, Beijing 102300, China
  • Online:2017-10-20 Published:2017-11-23
  • Contact: Wu Zhi’ang, professor, doctoral supervisor. Major research area: pharmaceutical administration research. Tel.: 13940328503, E-mail: 13940328503@139.com.

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摘要： Objective To establish a competency model for drug good manufacturing practice (GMP) inspectors after studying the current status of drug GMP inspectors’ competency in a certain city and to provide references for the perfection of relevant systems for drug GMP inspectors. Methods Behavioral event interview and expert interview were used to survey competency characteristics of the elite group of drug GMP inspectors, and the competency model for drug GMP inspectors were constructed and verified. Next this competency model was used to investigate the status of drug GMP inspectors in a certain city and to compare the differences in competency between the normal group and elite group of drug GMP inspectors. Results and Conclusion The competency model was tested and proved to be reliable and valid. There were many differences in the competencies between the normal group and elite group of drug GMP inspectors regarding the following seven areas: knowledge of laws and regulations, attention to order and quality, organizational ability, achievement orientation, influence, responsibility, and team leadership. The drug GMP inspector management system should be reformed by the following measures: improving inspector selection and training system, enhancing the legal position of drug GMP inspectors, establishing a specialized drug GMP inspector team, improving the inspector performance evaluation system, grading and salary incentive mechanisms.

关键词: drug GMP inspector, competency model, establishment

Abstract: Objective To establish a competency model for drug good manufacturing practice (GMP) inspectors after studying the current status of drug GMP inspectors’ competency in a certain city and to provide references for the perfection of relevant systems for drug GMP inspectors. Methods Behavioral event interview and expert interview were used to survey competency characteristics of the elite group of drug GMP inspectors, and the competency model for drug GMP inspectors were constructed and verified. Next this competency model was used to investigate the status of drug GMP inspectors in a certain city and to compare the differences in competency between the normal group and elite group of drug GMP inspectors. Results and Conclusion The competency model was tested and proved to be reliable and valid. There were many differences in the competencies between the normal group and elite group of drug GMP inspectors regarding the following seven areas: knowledge of laws and regulations, attention to order and quality, organizational ability, achievement orientation, influence, responsibility, and team leadership. The drug GMP inspector management system should be reformed by the following measures: improving inspector selection and training system, enhancing the legal position of drug GMP inspectors, establishing a specialized drug GMP inspector team, improving the inspector performance evaluation system, grading and salary incentive mechanisms.

Key words: drug GMP inspector, competency model, establishment

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