|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/cleaning-validation-in-pharmaceutical-industry/
课程评论：没有评论
课程名称：制药行业的清洁验证 课程概述：欢迎来到在线学习平台。本课程旨在教授清洁验证，特别关注其实践实施和合规方法。课程由6个不同的视频讲座组成。 1. 第一讲：清洁验证简介。 2. 第二与第三讲：详细讲解清洁验证的概念及其重要性，包括FDA的引用、监管机构的要求、质量风险管理的角色、寻找最坏情况限值、检测限（LOD）、定量限（LOQ）和回收研究的概念，接受限值的计算、取样方法、SMART目标，以及寻找微生物限值的不同方法。还将介绍如何应对审计、在制造厂引入新产品的处理，以及检查准备。 3. 剩下的三节讲座：涉及与清洁验证相关的关键问题及答案，例如： - 是否需要评估清洁验证中残留水平的变异性？ - 在清洁验证期间，是否需要待擦拭和冲洗样品获得批准后才能使用设备进行生产？ - 在最大允许残留计算中，是否需要根据制剂的性质使用安全因子？ - 制造强效化合物（如细胞毒性、致突变性或高药效活性化合物）是否需要专用设备？ - 测试冲洗液是否足以支持清洁验证中的残留确定？ - 企业是否需要验证设备在清洁前允许的最大脏污时间？ - 是否需要对非接触表面的清洁过程进行验证？ - 清洁验证是否也需要分为过程设计、过程确认及持续过程验证三个阶段？ - 清洁验证报告的审批仅由质量保证部门负责。 本课程为希望深入了解和实施清洁验证的制药专业人士提供了系统性的知识和实践指导。
Welcome to the online learning platform. This session is for learning the Cleaning validation with a special focus on practical implementation and compliance approach.This session comprises of total 6 different video lectures.1. The first lecture - Is an introduction to cleaning validation. 2. The Second and Third lectures - Are detailed sessions. These sessions will help to understand what is cleaning validation, and why it is important. Examples of FDA citations, regulatory agency's requirements, the role of quality risk management, finding worst case limit, LOD, LOQ, and recovery study concepts, calculation of the acceptance limit, sampling methodologies, SMART objectives, and different methodologies of finding the microbiological limits. Surviving audits with the aspect of cleaning validation, Handling of new product introduction in the manufacturing plant, and inspection readiness.3. The remaining three lectures - Include key questions and answers related to cleaning validation. The questions are below;1. Is it required to evaluate the variability in residue levels during cleaning validation?2. During cleaning validation, Do we have to wait for swab and rinse samples to be approved before using the equipment for production?3. During MACO (Maximum Allowable Carry Over) calculation, Do we have to use a safety factor depending on the nature of the formulation?4. Is Dedicated equipment required for manufacturing potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity)?5. Is testing rinse solution enough to support residue determinations for cleaning validation?6. Is it necessary for companies to validate a maximum time allowed for a piece of equipment to be dirty before cleaning?7. Do we need to perform validation of the cleaning process for product non-contact surfaces?8. As we know that, process validation is done in three stages - Process design, process qualification, and continued process verification. Whether the cleaning validation also to be done in three stages?9. Only QA is responsible for approval of the cleaning validation report.
