趋势分析在疫苗产品批签发管理中的应用

目的 趋势分析作为生产企业和国家监管当局/国家质量控制试验室（NRA/NCLs）控制产品质量和一致性的手段是十分重要的,WHO在批签发指南中以及我国的《药品生产质量管理规范》（2010年修订）中均明确要求：生产企业和NRA/NCLs应对所有的关键质量控制参数进行趋势分析.本研究通过对趋势分析方法的论述为趋势分析方法在疫苗批签发中的应用提供参考.方法 应用趋势分析方法对疫苗批签发实际工作中发现的问题进行阐述.结果与结论 通过实际应用趋势分析的手段对产品质量进行了持续性分析,发现影响产品质量趋势的一些因素,并对产生的原因进行分析.结果证明趋势分析是有效的分析产品质量的手段之一,趋势分析可以显示在一定生产周期内产品的质量变化,可以发现产品质量的偏差,是企业及NRA/NCsL对生物制品日常监管的重要质量控制分析方法,对保证产品的质量和生产过程的一致性具有重要的价值.

Application of Trend Analysis Method for Vaccine Lot Release

Objective Trend Analysis is a crucial method for manufacturers and NRA/NCLs to control the quality and consistency of products, in the Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities from WHO and cGMP from China CFDA, it is pointed out that Trend Analysis should be used in critical quality control parameters. This article is providing some important examples on how to use Trend Analysis method to control the quality of products in Lot Release and in self-inspection. Methods Using Trend Analysis method to detect the shift and significant difference in the quality of products. Results and Conclusion Trend Analysis can show the changes in a certain period of time. Through constantly analyzing the trend of quality of products, we can find the factors affectting the quality of products. Then we can analyze the reason which caused the bias. In conclusion, Trend Analysis is a valuable method for manufactures and NRA/NCLs to control the quality of products in routine practice.