The Research Progress on Visible Particulates in Injections
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 different 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.
injectionvisible particulatessource and controlinspection methodquality control
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