|
| 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 countermeasures in the early R D stage of biologics |
| 投稿时间：2023-06-08 修订日期：2023-12-04 |
| DOI： |
| 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 |
| 基金项目: |
|
| 摘要点击次数: 457 |
| 全文下载次数: 0 |
| 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,从而有助于提升生物制品的研发质量与效率。方法: 本文首先汇总分析了我国现行与生物制品研发质量管理相关的法规,分析了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,概括了早期研发过程中存在的研发质量管理问题,并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”等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: 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 the quality and efficiency of biologics R D. Methods: This article summarizes and analyzes the current laws and regulations related to the quality management of biologics R D in China. It also analyzes the fit between the regulatory requirements and the current situation of biologics R D. The problems in quality management of the early R D process are summarized based on the early R D characteristics, and the countermeasures and suggestions for solutions are put forward. Results and conclusion: At this stage, the laws and regulations related to the quality management of biologics R D that have been promulgated in China mainly involve the middle and late stages of R D. As it in the early stage, there is a lack of clear, detailed and executable regulatory documents. Several issues are identified in the early R D process of biologics, which involve organizational structure/personnel setting, functional division, management system, system execution and training, research materials, material and supplier management, and sample management. Conclusion: To improve the quality management in the early R D process of biologics, the following points should be emphasized: (1) Establish a quality management department for R D of biologics with defined rights and responsibilities; (2) Establish a hierarchical biologics R D quality management documentation system; (3) Adopt the principle of “crisscrossing and practicality” to formulate R D quality management documents; (4) Enhance the application of quality management tools; (5) Carry out quality management of the early R D of biologics by adopting a mode of project management; (6) Establish and improve the R D project code number management system, and strengthen the sample management in the early R D stage; (7) Establish and improve the R D training system. |
|
View Fulltext
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|