| 朱馨,龚前飞,李香玉.PIC/S及欧美基于风险制定GMP检查计划对我国药品检查的启示[J].中国药事,2023,(5):520-526 |
| PIC/S及欧美基于风险制定GMP检查计划对我国药品检查的启示 |
| The Establishment of GMP Inspection Plan Based on Risk in PIC/S, European and American and the Enlightenment to Drug Inspection in China |
| 投稿时间：2023-01-09 |
| DOI：10.16153/j.1002-7777.2023.05.005 |
| 中文关键词: 药品检查合作计划 GMP 检查计划 风险管理 药品监管 |
| 英文关键词: Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP inspection plan risk management drug regulation |
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| 中文摘要: |
| 目的：将我国GMP药品检查管理要求与药品检查合作计划(PIC/S)进行比较研究，为提高我国药品GMP检查管理的规范性、系统性，提升检查排查风险的能力提供对策建议。方法：通过文献研究分析PIC/S及欧美药品监管机构执行基于风险制定药品GMP检查计划情况，探索我国实施基于风险制定 GMP检查计划的路径。结果与结论：基于风险制定GMP检查计划的理念已在PIC/S和欧美药品监管检查体系中广泛实施，并形成当地适用的较为成熟的模型，发挥了集约检查资源、有效排查隐患的效能。本文结合我国药品监管法规体系中对检查程序的相关要求，分析我国基于风险制定GMP检查计划的实施现状和挑战，从制定基于风险的检查计划、明细检查程序、保障检查资源等方面提出对策建议，以统一规范药品监管机构药品检查运行机制和标准，提高药品检查效能。 |
| 英文摘要: |
| Objective: To provide countermeasures and suggestions for improving the standardization and systematization of GMP inspection management in China and ability improvement of inspection and risk elimination by a comparative study of GMP inspection standards and guidelines in China and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods: Through literature research, the implementation of risk-based GMP inspection plans for drugs by PIC/S, European and American drug regulatory authorities was analyzed, and the path of implementing risk-based GMP inspection plans in China was explored. Results and Conclusion: The concept of formulating GMP inspection plans based on risk has been widely implemented in PIC/S, European and American drug regulatory inspection systems, and has formed a relatively mature model applicable locally, giving full play to the eff ectiveness of intensive inspection resources and eff ective investigation of hidden dangers. Based on the relevant requirements for inspection procedures in China's drug regulatory system, this paper analyzes the implementation status and challenges of risk-based GMP inspection plans in China, and puts forward countermeasures and suggestions from the aspects of formulating risk-based inspection plans, detailed inspection procedures, and ensuring inspection resources, so as to unify and standardize the operation mechanism and standards of drug inspection by drug regulatory authorities and improve the effi ciency of drug inspection. |
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