Research on the Construction of Drug Inspection Evaluation Indicator System

Abstract

Objective To study a way to establish a drug inspection evaluation system in China. Methods Through literature research, behavioral event interviews, Delphi expert interviews, and other methods, the theory of “threedimensional quality structure model” was used to extract, screen, and construct a set of evaluation indicator system for drug inspection, including 3 first-level indicators, 11 second-level indicators, and 47 third-level indicators. Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China. According to the requirements of laws, regulations, and departmental rules, combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory, some management tools are put forward to improve the quality system of drug supervision.

Keywords

drug inspection / quality / evaluation indicator system / three-dimensional quality structure model / Delphi

References

[1] National Medical Products Administration. Measures for the Administration of Drug Inspection (Trial Implementation)[EB/OL]. (2021-05-28)[2022-11-20]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20210528171603115.html.

[2] Zhai Tiewei. How to build a quality management system for drug inspection institutions[J]. Capital Medicine, 2013, 20 (15): 56-57.

[3] World Health Organization. Quality management system requirements for national inspectorates[J]. WHO Drug Information, 2019, 33 (2): 159-173.

[4] Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. PIC/S Audit Checklist, PS/W 1/2005 (Rev. 3)[EB/OL]. (2022-04-19)[2022-11-20]. https://picscheme.org/docview/4647.

[5] European Medicines Agency.Compilation of Union Procedures on Inspections and Exchange of Information, EMA/224865/ 2022 Rev 18 Corr. [EB/OL]. (2022-04-20)[2022-11-20]. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf.

[6] Tang Wenyan, Zhang Hua, Li Jianping, et al. Contrastive study on the training standard system of GMP inspector at home and abroad[J]. Shanghai Medical &Pharmaceutical Journal, 2017, 38 (8): 55-57.

[7] National Medical Products Administration. Statistical Report on Drug Regulation and Administration (The Third Quarter of 2021)[EB/OL]. (2022-03-18) [2022-11-20]. https://www.nmpa.gov.cn/zwgk/tjxx/tjnb/20220318160852122.html.

[8] Zhao Weihan. A study on China pharmaceutical inspection quality management system in accordance with international standards[D]. Jinan University, 2015.

[9] Fan Linlin, Liang Yi. Implementation of FDA-EU mutual recognition agreement for the impact of pharmaceutical enterprises in China[J]. Chinese Journal of Pharmaceuticals, 2019, 50 (2): 229-232.

[10] Donabedian A. Some issues in evaluating the evaluating the quality of nursing care[J]. American Journal of Public Health, 1969, 59 (10): 1833-1834.

[11] He Gefei, Sun Ji, Huang Juanjuan, et al. Study on the rationality evaluation indicator system of antibiotics with Delphi method[J]. China Pharmacy, 2019, 30 (14): 1881-1885.

[12] Deng Mingying, Shi Tianlu, Jiang Ling, et al. Investigation of rationality evaluation indicators screening method of prophylactic application of antibiotics during perioperative period[J]. China Pharmacy, 2011, 22 (33): 3159-3162.

[13] Wu Qiaomei, Zhang Lijuan, Zheng Jingxia. Development of indicator system of aspiration risk evaluation in ICU with Delphi method[J]. Journal of Nursing (China), 2018, 25 (2): 1-6.

[14] Liu Shiquan, Zhou Yubi, Li Qien, et al. Expert consensus on the medicinal resources and clinical application of tibetan medicine “Dida” based on Delphi method[J]. China Pharmacy, 2021, 32 (12): 1416-1420.