关于注射剂中可见异物研究进展

The Research Progress on Visible Particulates in Injections

注射剂可见异物是目前注射剂产品常见的问题之一,也一直是全球监管机构和行业内激烈讨论的问题。尽管业界对可见异物的定义及判断标准有一定的共识,但在实际生产过程中,对于如何控制可见异物仍然存在不同的理解和掌握尺度。此外,企业在生产过程中对于检测人员的技能要求和设备的验证也缺乏权威的参考和依据,如可见异物的标准物质和相关技术指导文件等,这些对于国内注射剂的生产和质量控制影响都很大。本研究旨在开展关于“注射剂中可见异物”的文献调查,通过收集和整理国内外相关文献,对本领域的相关研究进展进行分析总结,为提高注射剂质量提供参考。

The presence of visible particulates in injection products is one of the common issues today,and has always been a hotly debated topic among global regulatory agencies and the industry.Although there is a certain consensus in the industry regarding the definition and judgment criteria of visible particulates,there are still diff erent understandings and mastery scales in practical production processes regarding how to control them.In addition,there is a lack of authoritative references and guidelines for companies in terms of skill requirements for inspectors and equipment validation,such as standard substances for visible particulates and related technical guidance documents.These have a significant impact on the production and quality control of domestic injection products.The aim of this study is to conduct a literature survey on"visible particulates in injections"by collecting and organizing relevant domestic and international literature to analyze and summarize the research progress in this field,providing references for improving the quality of injection products.