摘要
新版GMP提出了质量风险管理的理念,质量风险管理是以药品的风险评价为核心,依据评估结果采取适宜的策略控制药品风险,对药品整个生命周期质量风险进行评估、控制、沟通和审核的系统化过程。只有在整个产品生命周期中保持质量的稳定,才能确保产品的重要质量指标在产品生命周期的各阶段均保持与其在临床研究阶段一致。通过前瞻意义上的辨识与控制在研发与制造过程中的潜在质量问题,有效的质量管理能进一步给患者提供高质量的药物产品质量的保证。作为药品生产企业,如何适应法规的新变化,如何基于风险进行药品生产与质量控制,将是一个新的课题。
In new version of GMP, the concept of quality risk management has been presented. In this concept, the risk assessment for drugs is used as the core, and base on the result of assessment, suitable strategy is applied to control the risk of drugs, so that whole life period of drugs is systematically assessed, controlled and verified. Only the quality is kept stable in whole life period of product, can the important quality indicators of the product be ensured to be kept with that in clinical research stage. Through the cognition and control of potential quality problems in development and production, patients can be ensured with high quality drugs from high efficient quality management. As for pharmaceutical enterprises, how to adapt to new changes in regulation and bow to carry out pharmaceutical production and quality control are new themes.
出处
《医药工程设计》
2012年第2期32-35,共4页
Pharmaceutical Engineering Design
关键词
风险管理
风险评估
验证
药品生产
quality
risk management
risk assessment
validation
pharmaceutical production
