| 周朋,任思宁,张楠,刘媛.生物制品早期研发阶段常见的研发质量管理问题及对策[J].中国药事,2023,(12):1398-1407 |
| 生物制品早期研发阶段常见的研发质量管理问题及对策 |
| Analysis of Common R&D Quality Management Problems and Countermeasuresin the Early R&D Stage of Biologics |
| 投稿时间：2023-06-08 |
| DOI：doi:10.16153/j.1002-7777.2023.12.009 |
| 中文关键词: 生物制品 早期研发阶段 研发质量管理 问题 对策 |
| 英文关键词: biologics early R&D stage R&D quality management problems countermeasures |
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| 中文摘要: |
| 目的：为规范生物制品早期研发工作，提高早期研发质量管理水平提供建议，提升生物制品的研发质量与效率。方法：汇总我国现行与生物制品研发质量管理相关的法规，分析法规要求与生物制品研发现状的契合度，根据生物制品早期研发阶段的特点，概括早期研发过程中存在的研发质量管理问题，提出解决问题的对策与建议。结果：现阶段我国已颁布的与生物制品研发质量管理相关的法规主要涉及研发中后期，对于早期阶段的质量管理，缺少明确、细致、可执行的法规文件。生物制品早期研发过程中在组织架构/人员设置、职能划分、管理制度、制度执行与培训、研究资料、物料和供应商管理以及样品管理7个方面存在问题。结论：加强生物制品早期研发过程的研发质量管理应注意以下几点内容：（1）建立权责明确的生物制品研发质量管理部门；（2）建立层次分明的生物制品研发质量管理文件体系；（3）采取“纵横交错、贴合实际”的原则来制定研发质量管理文件；（4）加强质量管理工具的应用；（5）采用项目管理模式开展生物制品早期研发质量管理；（6）建立与健全研发项目代码编号管理制度，加强早期研发阶段的样品管理；（7）建立与完善研发培训体系。 |
| 英文摘要: |
| Objective: To provide suggestions for standardizing the early research and development (R&D)of biological products and improving the quality management level of early R&D, in order to improve thequality and efficiency of biologics R&D. Methods: The current laws and regulations related to the qualitymanagement of biologics R&D in China were summarized and the fi t between the regulatory requirements andthe current situation of biologics R&D was analyzed. The problems in quality management of the early R&Dprocess were summarized based on the early R&D characteristics of biologics, and the countermeasures andsuggestions for solutions were put forward. Results: At this stage, the laws and regulations related to the qualitymanagement of biologics R&D that have been promulgated in China mainly involve the middle and late stagesof R&D. For the early stage of quality management, there was a lack of clear, detailed and executable regulatorydocuments. Several issues in seven aspects were identifi ed in the early R&D process of biologics, which involveorganizational structure/personnel setting, functional division, management system, system execution and training,research data, material and supplier management, and sample management. Conclusion: Strengthening the qualitymanagement in the early R&D process of biologics, the following points should be emphasized: (1) Establish aquality management department for R&D of biologics with defined rights and responsibilities; (2) Establish ahierarchical biologics R&D quality management documentation system; (3) Adopt the principle of “crisscrossingand practicality” to formulate R&D quality management documents; (4) Enhance the application of qualitymanagement tools; (5) Carry out quality management of the early R&D of biologics by adopting a mode of projectmanagement; (6) Establish and improve the R&D project code number management system, and strengthen thesample management in the early R&D stage; (7) Establish and improve the R&D training system. |
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