质量源于设计在血液制品生产工艺中的应用.PDFVIP

质量源于设计在血液制品生产 工艺中的应用 贾国栋博士 成都 生物制药研发总监 2015年10月22日 通用电气中国研发中心 Imagination at work. See tutorial regarding confidentiality disclosures. 主题内容 • 2011版工艺验证要求 （Process Validation, PV ） • 质量源于设计 （Quality by Design, QbD ）实施流程 • QbD 在静丙生产工艺验证 中的应用 Definition for Process Validation 工艺验证的定义 “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”工艺验证应当证明一个 生产工艺按照规定的工艺参数能够持续生产出符合预定用途和注 册要求的产品。。 - “Guideline on General Principles of Process Validation” May, 1987 “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products”收集并评估从工艺设计阶段一直 到商业化生产的数据 ，用这些数据确立科学证据 ，证明该工艺能 够始终如一地生产出优质产品 - “Guidance for Industry: Process Validation: General Principles and Practices”, What’s in new process validation guidance 新工艺验证的特点 Lifecycle concept links 3 stages of process validation activities生命周期验证与三批验证 差别 •Process Design工艺设计 –Product and process development •Process Qualification 工艺确认 –Qualification of the commercial manufacturing process •Continued Process Verification 持续验证 – Maintenance of the process in a state of control during routine commercial production Comparison between 1987 2011 1987 和2011验证指南的对比分析 工艺验证项目 87版 11版 工艺理解 少 深入全面 设计空间 NA Yes 产品质量 依赖检测，保证一致性 通过工艺设计，保证持续 一致性 偏差调查 经常