ICH指南应用篇-原料药工艺质量研究.pdfVIP

API研发中的质量研究概述 安建国 2019-03-21 内容 第一讲: ICH阐介 第二讲: QbD理念 第三讲: 基于QbD理念的分析方法开发-验证 第四讲: 稳定性研究 第五讲: 基于QbD的CTD重点章节描述 第一讲: ICH阐介 ICH-Q GUIDANCES (WWW.ICH.ORG) The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Quality Safety Efficacy Multidisciplinary 质量 安全 药效 综合 ICH-Q GUIDANCES: Q Section (质量) Q1A-Q1F ：STABILITY Q1A(R2) - Stability Testing for New Drug Substances and Products Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products Q1C – Stability Testing for New Dosage Forms Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E – Evaluation of Stability Data Q1F - Stability Data Package for Registration Applications in Climatic Zones III and IV ICH-Q GUIDANCES: Q Section (质量) Q2：ANALYTICAL VALIDATION Q3A-Q3D: IMPURITIES Q3A(R2) – Impurities in New Drug Substances Q3B(R2) - Impurities in New Drug Products Q3C(R6) - Impurities Guideline for Residual Solvents Q3D - Guideline for Elemental Impurities ICH-Q GUIDANCES: Q Section (质量) Q4, Q4A-Q4B: PHARMACOPOEIAS Q5A-Q5E: QUALITY OF BIOTECHNOLOGICAL PRODUCTS 质量标准 Q6A-Q6B: SPECIFICATION GMP Q7: GOOD MANUFACTURING PRACTICE Q8(R2): PHARMACEUTICAL DEVELOPMENT Q9: QUALITY RISK MANAGEMENT 质量源 Q10: PHARMACEUTICAL QUALITY SYSTEM 于设计 QbD Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES Q12: LIFECYCLE MANAGEMENT ICH-MGUIDANCES: M Section(综合) • M4 : The Common Technical Document (CTD) M4Q(R1): Quality • M7(R1): ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS T