|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/quality-in-pharmaceutical-industry-process-validation/
课程评论：没有评论
本课程“制药行业质量：GMP与工艺验证”深入探讨了药品生产中的关键环节——工艺验证。根据FDA和EMA的定义，工艺验证是指通过建立有 documented evidence，为特定工艺能够持续稳定地生产出符合预定规格和质量特性的产品提供高度保证。 课程内容全面，从基础通用定义涵盖到具体应用。 **核心内容结构如下：** * **第一部分：引言** 介绍工艺验证的背景。 * **第二部分：工艺验证通用定义** 详细列举了药品生产、质量控制、文件记录以及验证和确认等一系列关键术语，包括： * 药品（Drug Product）、原料药（API）、辅料、起始物料、中间产品、包装材料、散装产品、成品。 * 生产、包装、制造、制造商、上市许可。 * 质量保证（QA）、质量控制（QC）、过程内控制（IPC）。 * 标准操作规程（SOP）、批号、批记录、主控记录、主配方、检验标准。 * 校准（Calibration）、确认（Qualification）及其类型、验证（Validation）及其类型。 * 商业化生产工艺、工艺验证、工艺设计、工艺确认、持续工艺验证。 * 关键物料属性（CMA）、关键工艺参数（CPP）、关键质量属性（CQA）、质量目标产品概况（QTPP）。 * **第三部分：EMA与FDA的工艺验证要求** 对比和阐述两大监管机构在工艺验证方面的指南。 * **第四部分：工艺验证概述** 介绍工艺验证的引入、方法和目标。 * **第五部分：工艺验证的通用考量** 讨论工艺验证过程中需要考虑的普遍性因素。 * **第六部分：工艺设计** 强调在工艺设计阶段建立对工艺的认知和理解，并制定过程控制策略。 * **第七部分：工艺确认** 涵盖设施的设计、公用工程和设备的确认，以及工艺性能确认（PPQ），包括PPQ方案和报告。 * **第八部分：持续工艺验证** 详细讲解上市后如何持续监控和验证工艺的稳定性。 * **第九部分：结论** 总结课程要点。 通过本课程的学习，学员将能全面理解并掌握制药行业中进行工艺验证的必要性、方法和要求，为确保药品质量和患者安全打下坚实基础。
Process validation is 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 characteristics. (FDA Definition)The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. (EMA Definition)In this course, basics of process validation are explained within the all details and requirements. Process validation studies are explained in three major section as process design, process qualification and continued process validation.COURSE CONTENT1 INTRODUCTION 2 GENERAL DEFINITIONS FOR PROCESS VALIDATION 2_1 GENERAL DEFINITIONS FOR PROCESS VALIDATION-I 2_1_1 Drug Product (Pharmaceutical Product) 2_1_2 Active Pharmaceutical Ingredient (API) 2_1_3 Inactive Pharmaceutical Ingredient 2_1_4 Starting Materials 2_1_5 Intermediate Product 2_1_6 Packaging Material 2_1_7 Bulk Product 2_1_8 Finished Pharmaceutical Product (FPP) (Drug Product) (Final Product) 2_1_9 Manufacturing Flow Chart 2_2 GENERAL DEFINITIONS FOR PROCESS VALIDATION-II 2_2_1 Production 2_2_2 Packaging 2_2_3 Manufacture (Mnaufacturing) 2_2_4 Manufacturer 2_2_5 Marketing Authorization (Product Licence) (Registration Certificate) 2_2_6 Quality Assurance 2_2_7 Quality Control 2_2_8 In-Process Control 2_3 GENERAL DEFINITIONS FOR PROCESS VALIDATION-III 2_3_1 Standart Operating Procedure (SOP) 2_3_2 Batch (Lot) 2_3_3 Batch Number (Lot Number) 2_3_4 Batch Record 2_3_5 Master Record 2_3_6 Master Formula 2_3_7 Specification 2_3_8 Authorized Person 2_4 GENERAL DEFINITIONS FOR PROCESS VALIDATION-IV 2_4_1 Calibration 2_4_2 Qualification 2_4_3 Types of Qualification 2_4_4 Validation 2_4_5 Types of Validation 2_5 GENERAL DEFINITIONS FOR PROCESS VALIDATION-V 2_5_1 Commercial Manufacturing Process 2_5_2 Process Validation 2_5_3 Process Design 2_5_4 Process Qualification 2_5_5 Continued Process Verification 2_6 GENERAL DEFINITIONS FOR PROCESS VALIDATION-VI 2_6_1 Critical Material Attribute (CMA) 2_6_2 Critical Process Parameter (CPP) 2_6_3 Critical Quality Attribute (CQA) 2_6_4 Quality Target Product Profile (QTPP) 3 PROCESS VALIDATION ACCORDING TO EMA & FDA 4 INTRODUCTION TO PROCESS VALIDATION 4_1 Introduction to Process Validation 4_2 Approach to Process Validation 4_3 Aims of Process Validation 5 GENERAL CONSIDERATION FOR PROCESS VALIDATION 6 PROCESS DESIGN 6_1 Introduction to Process Design 6_2 Building and Capturing Process Knowledge and Understanding 6_3 Establishing a Strategy for Process Control 7 PROCESS QUALIFICATION 7_1 Introduction to Process Qualification 7_2 Design of a Facility and Qualification of Utilities and Equipment 7_3 Process Performance Qualification 7_4 Process Performance Qualification Protocol 7_5 Process Performance Qualification Report 8 CONTINUED PROCESS VERIFICATION 8_1 Continued Process Verification 9 CONCLUSION
