3、maceutical quality based on Good Manufacturing Practice (GMP) risk management. Q1A - Q1F Stability稳定性稳定性 Q1A(R2) Stability Testing of New Drug Substances and Products 新原料药和制剂的稳定性试验Q1B Stability Testing : Photostability Testing of New Drug Substances and Products 新原料药和制...
“M”MMULTIDISCIPLINARY,M5 M1:MedDRA M2: M3: M4:(CTD) M5: QualityGuidelines HarmonisationachievementsintheQuality areaincludepivotalmilestonessuchas theconductofstabilitystudies,defining relevantthresholdsforimpuritiestesting andamoreflexibleapproachto pharmaceuticalqualitybasedonGood ManufacturingPractice(GMP)risk ...
培训学习资料-ICH指导原则
ICHQ7A原料药的GMP指南.pptx,ICHQ7A原料药的GMP指南 REPORTING 目录 引言 原料药GMP基本要求 质量控制与质量保证 变更控制与风险管理 供应商管理与合作伙伴选择 监管检查与符合性验证 总结与展望 PART 01 引言 REPORTING 01 02 03 PART 02 原料药GMP基本要求 REPORTING 厂
ICH&ICHGuidelines 更新日期：2016.12BKYang 目 •ICH简介 录 • ICH指导原则简介 “Q‖类专题——QualityGuidelines ―S‖类专题——SafetyGuidelines ―E‖类专题——EfficacyGuidelines―M‖类专题——MultidisciplinaryGuidelines ICH简介 •名称2015.10.23更名为：InternationalCouncilfor...
Quality Guidelines 质量研究指导原则 Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk ...
质量(Quality Guidelines) Q1 Stability/稳定性 Q2 Analytical Validation/分析方法验证 Q3A - Q3D Impurities/杂质 Q4 - Q4B Pharmacopoeias/药典 Q5A - Q5E Quality of Biotechnological Products/生物技术产品质量 Q6A- Q6B Specifications/规格 Q7 Good Manufacturing Practice/GMP Q8 Pharmaceutical Development/药...
FDA,GMP,ICH临床实验专业英语词汇互译 FDA常用词中英对照 FDA(food and drug adminisration)美国)食品药品监督管理局 NDA(new drug application):新药申请 ANDA(abbreviated new drug application):简化新药申请 EP(export application):出口药申请(申请出口不被批准在美国销售的药品) treatment IND:研究中的新药用于治...
Q7 Good Manufacturing Practice/GMP Q8 Pharmaceutical Development/药物研发 Q9 Quality Risk Management/质量风险管理 Q10 Pharmaceutical Quality System/药物质量体系 Q11 Development and Manufacture of Drug Substances/化学药品的研发与生产 Q12 Techinical And Regulatory Considerations For Pharmaceutical Product Lifecycle...
在ICH Q7中描述的GMP规定适用于开始于起始原料之后的每一个分支。在GMP下实施的生产步骤和恰当的控制策略一起确保原料药的质量。 A starting material should be a substance of defined chemical properties and structure. Non-isolated intermediates are usually not considered appropriate starting materials; 一个...