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所在平台: Udemy |
课程主页: https://www.udemy.com/course/sterile-drug-product-manufacturing-in-pharma-industry/
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课程名称：制药行业无菌药品制造 课程概述：无菌剂型是指用于皮下注射或其他外部组织边界的制剂。无菌药品是直接注入血液或体内组织的剂型。无菌剂型的制造需以极高的标准进行，采用确保符合药典要求的程序。无菌制造操作需要机械精度、消毒和灭菌。无菌药品的制造包括无菌加工和终端灭菌。课程将在范围内讨论无菌药品的最重要特性、无菌药品的制造技术及其质量要求。 课程大纲： 1. 介绍 2. 无菌药品制造概述 2.1 无菌药品制造简介 2.1.1 药品产品 2.1.2 药品物质 2.1.3 药品剂型 2.1.4 药品产品质量要求 2.1.5 无菌药品产品质量要求 2.1.6 无菌药品制造 2.2 无菌药品制造的基础定义 2.2.1 标准操作程序（SOP） 2.2.2 批记录 2.2.3 主记录 2.2.4 规范 2.3 其他基本定义 2.3.1 清洁区 2.3.2 洁净室 2.3.3 污染 2.3.4 交叉污染 2.4 更多基本定义 2.4.1 HVAC（加热、通风和空调） 2.5 校准和验证等基础定义 2.6 无菌加工设施、微生物负荷、消毒等基础定义 2.7 滤器灭菌、热灭菌、辐射灭菌等基本定义 2.8 人员监测、非活性颗粒监测等基础定义 3. 无菌药品的特性 3.1 安全性 3.2 无菌性 3.3 稳定性 3.4 兼容性 3.5 非热源性 3.6 无颗粒性 3.7 滲透性 4. 无菌药品的分类 4.1 无菌剂型及产品分类 4.2 小体积注射剂 4.3 大体积注射剂 4.4 特殊无菌剂型 5. 无菌药品的包装选择 5.1 无菌产品的主要包装和容器系统 5.2 安瓿瓶 5.3 小瓶/瓶子 5.4 注射器 6. 无菌药品制造的质量保证 6.1 质量要求 6.2 制造文档 7. 无菌药品制造概述 7.1 制造过程类型 7.1.2 终端灭菌 7.1.3 无菌过程（过滤灭菌） 8. 无菌药品的无菌制造 8.1 无菌过程 8.2 无菌制造的资格和验证要求 8.3 无菌生产过程验证研究 9. 结论 该课程为制药行业的专业人士提供了无菌药品制造的关键知识，适用于提高药品质量标准和生产操作流程。
Sterile dosage forms are defined as preparations intended for injection through the skin or other external boundary tissue. Sterile drug products are the dosage forms that are administered directly into the blood stream or body tissue. Sterile dosage forms are manufactured with extreme care by procedures designed to ensure that pharmacopeial requirements. Sterile manufacturing operations require mechanical excellence, sanitization, and sterilization. Manufacturing types for sterile drug products are aseptic manufacturing and terminal sterilization. In the scope of this course, most important characteristics of the sterile drug product, manufacturing techniques of sterile drug products and quality requirements of sterile manufacturing have been discussed.COURSE AGENDA1 Introduction2 Introduction to Sterile Drug Manufacturing 2.1. Introduction to Sterile Drug Manufacturing 2.1.1. Pharmaceutical Drug Product 2.1.2. Pharmaceutical Drug Substance 2.1.3. Pharmaceutical Dosage Forms 2.1.4. Quality Requirements of Pharmaceutical Drug Product 2.1.5. Quality Requirements of Pharmaceutical Sterile Drug Product 2.1.6. Pharmaceutical Sterile Drug Product Manufacturing 2.2. Basic Definitions - 1 for Sterile Drug Manufacturing 2.2.1. Standart Operating Procedure (SOP) 2.2.2. Batch Record 2.2.3. Master Record 2.2.4. Specification 2.3. Basic Definitions - 2 for Sterile Drug Manufacturing 2.3.1. Clean Area 2.3.2. Clean Room 2.3.3. Contamination 2.3.4. Cross-Contamination 2.4. Basic Definitions - 3 for Sterile Drug Manufacturing 2.4.1. HVAC (Heating, Ventilation, and Air-Conditioning) 2.4.2. Airlock 2.4.3. Airlock Types (Personnel & Material) 2.4.4. Airlock Types (Pressure Movement) 2.4.5. Laminar Flow 2.5. Basic Definitions - 4 for Sterile Drug Manufacturing 2.5.1. Calibration 2.5.2. Qualification 2.5.3. Types of Qualification 2.5.4. Validation 2.5.5. Types of Validation 2.6. Basic Definitions - 5 for Sterile Drug Manufacturing 2.6.1. Aseptic Processing Facility 2.6.2. Bioburden 2.6.3. Disinfection 2.6.4. Endotoxin (Pyrogen) 2.6.5. Depyrogenation 2.7. Basic Definitions - 6 for Sterile Drug Manufacturing 2.7.1. Filter Sterilization 2.7.2. Heat Sterilization 2.7.3. Radiation Sterilization 2.7.4. Ethylene Oxide Gas Sterilization 2.8. Basic Definitions - 7 for Sterile Drug Manufacturing 2.8.1. Personnel Monitoring 2.8.2. Non Viable Particulate Monitoring 2.8.3. Surface monitoring 2.8.4. Active air monitoring 2.8.5. Passive air monitoring 3 Characteristics of Sterile Drug Product 3.1. Characteristics of Sterile Drug Product 3.2. Safety 3.3. Sterility 3.4. Stability 3.5. Compatibility 3.6. Nonpyrogenic 3.7. Particle Free 3.8. Tonicity 4 Classification of Sterile Drug Product 4.1. Sterile Dosage Forms & Classification of Sterile Product 4.2. Small Volume Parenterals (Injections) 4.3. Large Volume Parenterals (Infusions) 4.4. Special Sterile Dosage Forms 5 Packaging Selection for Sterile Drug Product 5.1. Primary Packaging and Container Systems of Sterile Product 5.2. Ampoule 5.3. Vials / Bottles 5.4. Syringes 6 Quality Assurance for Sterile Drug Product Manufacturing 6.1. Quality Requirements for Sterile Drug Product Manufacturing 6.2. Documentation for Sterile Drug Product Manufacturing 7 Overview to Sterile Drug Product Manufacturing 7.1.1. Sterile Drug Product Manufacturing Process Types 7.1.2. Terminal Sterilization 7.1.3. Aseptic Process (Sterilisation by Filtration) 8 Aseptic Sterile Drug Product Manufacturing 8.1. Aseptic Process 8.2. Aseptic Manufacturing Qualification and Validation Requirements 8.3. Aseptic Production Process Validation Studies 9 Conclusion
