Quality Risk Analysis of Human Prothrombin Complex Concentrate Extraction and Its Combination with Plasma for Blood Product Preparation
Objective:To analyze the potential quality risks in extracting human Prothrombin Complex Concentrate (PCC) from human plasma and producing other blood products,providing risk warnings and control measures to relevant enterprises and regulatory authorities to ensure public drug safety. Methods:Through a comprehensive review of literature and practical experience,the production process and quality control of PCC extraction from human plasma,along with its combination with plasma to manufacture other blood products,were analyzed. The safety and efficacy of producing human serum albumin (HSA) and intravenous immunoglobulin (IG) through the PCC process were also assessed. Additionally,the study compared the risks associated with switching from the direct production of HSA and IG to a process involving PCC extraction and its combination with plasma from the perspectives of process parameters,personnel,equipment,documents,and regulations.Based on this analysis,control measures were proposed. Results and Conclusion:The preparation process,raw material selection,and quality control of PCC,particularly the optimization of key process parameters,are crucial for the quality of both PCC and subsequent plasma-derived products. This study provides risk warnings and relevant recommendations for enterprises and regulatory authorities to refer to through the analysis of PCC preparation process,raw material characteristics and process change risk.
human Prothrombin Complex Concentrateextraction processquality controlrisk analysisblood products
万方数据
维普
