基于质量源于设计理念开发注射液生产工艺

Manufacturing Process Development of Injectable Drug Product Based on Quality by Design

质量源于设计以确定目标产品质量轮廓为起点,以了解关键物料属性、产品关键质量属性和关键工艺参数为前提,运用质量风险管理的方式,建立工艺设计空间和控制策略。基于Qb D所开发的生产工艺可终如一地生产出符合预期质量的产品。本文按照Qb D的理念,进行了卡铂注射液生产工艺的开发。所开发的生产工艺能稳定的生产出符合卡铂注射液质量标准要求的产品。

Quality by Design （QbD） starts from determination of Quality Target Product Profile （ QTPP）, based onthe knowledge obtained from the Critical Material Attribute （CMA）, Critical Quality Attribute （CQA） and CriticalProcess Parameter （CPP）, risk based approaches is used to develop a design space and control strategy. Themanufacturing process developed by QbD can produce product consistently meet the pre- defined specification. Themanufacturing process of carboplatin injection based on QbD was developed. The established manufacturing process canproduce drug product consistently meet the specification of carboplatin injection.