CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 1: 1 - 1-8

DOI: https://doi.org/10.2095-3593.2026.030001

Analysis of Quality Management System Elements in Pharmaceutical Inspectorates from Total Quality Management Perspective

Expand
  • Center for Food and Drug Inspection of National Medical Product Administration， Beijing 100163， China

Received date: 2025-09-08

  Revised date: 2025-11-18

  Accepted date: 2026-04-01

  Online published: 2026-04-01

Fold

Abstract

The quality management system for pharmaceutical inspection plays a crucial role in ensuring that inspection activities are standardized， professional， and consistent. It simultaneously promotes the continuous development of pharmaceutical inspectorates， can effectively reduce discrepancies among different inspectorates， and provides essential support for international mutual recognition of inspections. Based on the theory of total quality management， this study systematically reviewed the requirements of relevant domestic and international regulations and guidelines pertaining to pharmaceutical inspection and quality management. Integrating insights gained from practical experience and the latest research findings in pharmaceutical inspection， it explored and constructed a comprehensive quality management system framework for pharmaceutical inspectorates. This framework is centered on pharmaceutical inspection regulations and guidelines， ensuring all inspection activities are conducted under unified normative guidance. It utilizes the PDCA cycle as its core operational mechanism， achieving continuous quality improvement through iterative cycles of planning， doing， checking and acting. The framework is supported by two key pillars： pharmaceutical inspection standards and procedures， and a team of professional pharmaceutical inspectors. These pillars respectively solidify the system′s foundation from the dimensions of standardized institutional norms and human resource assurance. Furthermore， the framework is underpinned by fundamental quality management principles and modern scientific management methods， which together form its theoretical foundation， creating a hierarchical， well-structured， and coherent organic whole. The study further analyzed the specific connotations and implementation essentials of each quality management element within the context of the pharmaceutical inspection field. This research aims to provide theoretical foundation and practical guidance for pharmaceutical inspectorates in the process of establishing， implementing， evaluating， and continually improving their own quality management systems.

Key words： ; font-size:medium; ">Drug inspection； Quality management； Management elements； Inspection internationalization； Inspectorates

Cite this article

YAN Ruoxi . Analysis of Quality Management System Elements in Pharmaceutical Inspectorates from Total Quality Management Perspective[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(1) : 1 -1-8 . DOI: 10.2095-3593.2026.030001

References

     [1] 颜若曦. 药品检查创新方式分析与探讨[J]. 中国食品药品监管，2025，(4)：40-51.
     [2] WHO. TRS 1025-Annex 5： Quality management system requirements for national inspectorates[EB/OL]. (2020-04-21) [2025-05-01]. https：//www. who. int/publications/i/item/978-92-4-000182-4.
     [3] PIC/S. PIC/S Quality system requirements for pharmaceutical inspectorates [EB/OL]. (2007-09-25) [2025-05-01]. https：//picscheme. org/docview/3462.
     [4] WHO. WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products-Revision Ⅵ[EB/OL]. (2021-05-10) [2025-05-01]. https：//www. who. int/publications/i/item/9789240020245.
     [5] PIC/S. PIC/S Audit Checklist [EB/OL]. (2022-04-19) [2025-05-01]. https：//picscheme. org/docview/4647.
     [6] PIC/S. PIC/S Audit Checklist Interpretation Guide [EB/OL]. (2020-09-01) [2025-05-01]. https：//picscheme. org/docview/3549.
     [7] WHO. TRS 1025-Annex 13： Guideline on the implementation of quality management systems for national regulatory authorities [EB/OL]. (2020-04-21) [2025-05-01]. https：//www. who. int/publications/i/item/978-92-4-000182-4.
     [8] 宋福鱼，曹轶，安慧芬，等. WHO 医疗产品良好监管规范要求及对我国药品检查机构质量管理体系评价的思考[J]. 中国食品药品监管，2024，(12)：38-45.
     [9] 范瑞雪，张婕颖，李军，等. 基于政策文本的分析探讨我国药品检查体系的变迁[J]. 中国食品药品监管，2025，(1)：74-85.
     [10] 中国政府网. 国务院办公厅关于建立职业化专业化药品检查员队伍的意见（国办发〔2019〕36号）[EB/OL]. (2019-07-18) [2025-05-01]. https：//www. gov. cn/zhengce/zhengceku/2019-07/18/content_5411172. htm.
     [11] 郭威， 梁毅. 加入PIC/S对我国药品检查员培训和质量风险管理下药品检查的启示[J]. 中国医药工业杂志，2025，56(5)：680-686.
     [12] 李海山，刘莹莹，杨宇. 加入PIC/S对我国职业化专业化药品检查员队伍建设的思考[J]. 中国药事，2024，38(8)：869-875.
     [13] 朱生力，成立，张庆. 我国药品检查员培训要求与实施现状比较[J]. 中国药业，2025，34(1)：8-13.
     [14] 李武超，颜若曦. 药品生产现场检查能力评估标准探讨[J]. 中国医药导刊，2025，27 (2)：117-122.
     [15] WHO. Guidance on good manufacturing practices： inspection report [EB/OL]. (2016-10-31) [2023-02-26]. https：//www. who. int/ publications/m/item/guidance-on-good-manufacturing-practices-inspection-report.
     [16] 颜若曦. 基于《PIC/S GMP缺陷分级指南》的药品生产质量管理规范检查缺陷分级研究[J]. 现代药物与临床，2023，38（6）：1509-1516.
     [17] PIC/S．Standard operating procedure of team inspections[EB/OL]. (2009-07-29) [2025-05-01]. https：//picscheme. org/docview/3460.
     [18] 颜若曦. 药品生产企业质量保证系统要点分析[J]. 医药导报，2022，41(1)：132-135.
     [19] 颜若曦. 药品生产质量管理中管理评审探讨与常见问题分析[J]. 中国药物评价，2025，42(1)：78-80.
     [20] ISO. ISO 9001：2015： Quality management systems： Requirements[EB/OL]. (2015-09-23) [2025-05-01]. https：//www. iso. org/obp/ui/en/#iso：std：iso：9001：ed-5：v1：en.
     [21] ICH. Q9(R1)：Quality Risk Management[EB/OL]. (2023-01-18) [2025-05-01]. https：//database. ich. org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2025_0115. pdf.
     [22] 宋福鱼，曹轶. 药品检查关键绩效指标建立研究[J]. 中国药物警戒，2024，21(12)：1411-1414.
     [23] ICH. Q10： Pharmaceutical Quality System[EB/OL]. (2008-06-04) [2025-05-01]. https：//database. ich. org/sites/default/files/Q10%20Guideline. pdf.
     [24] 吴旭辰，张盈，许贤，等. 知识管理在药品审核查验工作中的运用探讨[J]. 中国食品药品监管，2025，(3)：148-153.
     [25] 龚前飞，朱馨，陈桂良. 国外药品检查机构质量体系构建指南介绍及对我国的启示[J]. 中国药事，2021，35(4)：438-445.
     [26] 冉红，刘德芳，王娅，等. 四川省药品技术检查现状分析及建议[J]. 中国药业，2025，34(5)：23-26.
Options
Outlines

/

〈 〉

[an error occurred while processing this directive]