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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-manufacturing-practices-gmp-gmp-audits/
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本课程“良好生产规范 (GMP) 与 GMP 审计”旨在全面介绍制药行业中至关重要的 GMP 原则及其审计实践。 课程首先从 GMP 和 GMP 审计的定义和目标入手，强调 GMP 作为质量保证的关键组成部分，旨在确保产品的一致性和质量，降低生产风险。随后，深入探讨 GMP 审计的通用信息，以及作为 GMP 基础的质量体系，包括 GMP 的基本要求和药物质量管理体系。 课程内容覆盖了 GMP 的核心要素： * **人员**: 详细讲解人员的资质、培训以及卫生要求。 * **厂房与设备**: 涵盖了生产区、储存区和质量控制区域的厂房布局、设备选型、维护和清洁要求。 * **文件**: 强调所有生产和质量控制活动必须有据可查，涉及规格、生产文件等关键文件。 * **生产**: 重点关注生产过程中的污染、交叉污染和混淆的防范。 * **质量控制**: 介绍质量控制的基本原则和良好实验室规范 (GLP)。 * **质量保证**: 深入讲解产品质量回顾 (PQR)、偏差管理、变更控制、客户投诉处理以及纠正和预防措施 (CAPA)。 最后，课程还将探讨额外的审计问卷，并对 GMP 和 GMP 审计的要点进行总结，帮助学员建立起系统的 GMP 认识和应对审计的能力。
Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. GMP Audit refers to regular visits to evaluate facilities, production and ensure that all activities are in line with current good manufacturing practices (cGMP). Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. COURSE AGENDA 1 Introduction to GMP & GMP AUDITS 2 General Information about GMP Audits 3 Quality System 3.1. Good Manufacturing Practices (GMPs) 3.2. Basic Requirements of Good Manufacturing Practices (GMPs) 3.3. Pharmaceutical Quality System 4 Personnel 4.1. Personnel 4.2. Personnel & Hygiene 5 Premises & Equipments 5.1. General Information about Premises & Equipments 5.2. Premises & Equipments Requirements in Manufacturing Area 5.3. Premises & Equipments Requirements in Storage Area 5.4. Premises & Equipments Requirements in Quality Control 5.5. Equipment 6 Documentation 6.1. General Information about Documentation 6.2. Specification 6.3. Manufacturing Documentation 7 Production 7.1. General Information about Production 7.2. Contamination, Cross Contamination, Mix-up 7.3. Cross-Contamination 8 Quality Control 8.1. General Information8.2. Good Laboratory Practices 9 Quality Assurance 9.1. Product Quality Review (PQR) 9.2. Complaints 9.3. Change Management 9.4. Deviation 9.5. Corrective Action & Preventive Action 10 Additional Audit Questionare 11 Conclusion
