Analysis of Technical Requirements,Research Strategies and Typical Prob-lems of Batch Size Change in Post-approval Chemical Drug Injections
Based on reviewing the guidance and technical requirements for batch size changes in pro-duction of marketed chemical drug injections,this article elaborates on the research ideas of changes in aspects such as related changes,process validation and quality comparative studies.Combining with the re-view of post-market registration management matters for changes in daily practice,this article summarizes some common issues in change management,such as incomplete description of change information,failure to comply with relevant guidance for validation,lack of comprehensive quality comparison and non-stan-dardized stability research.
万方数据
维普
