2024 C&Q主题沙龙 苏州场

Commissioning and Qualification Training Course

Science and Risk-based Commissioning and Qualification - Applying the ISPE Baseline Guide, Volume-5, Second Edition: Commissioning and Qualification (T40)

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

由美国食品药品监督管理局（FDA）和欧盟（EU）领导的全球监管期望和指南指出，所有制药质量体系都应采用QRM（质量风险管理）方法。通过互动研讨会，本课程将根据最近发布的第2版指南、ICH文件Q8（R2）、Q9和Q10、当前监管指南、行业最佳实践和ASTM E2500，通过对系统、设备和设施进行确证，解释并应用基于科学和风险的整合生命周期调试和确认方法。

NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course.

注：强烈建议学员在参加本课程之前熟悉调试和确认的基本概念。

你将学到什么

• Applying the QRM C&Q Process Flow

应用QRM C&Q流程

• Principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness-for-use/qualification as required by major global regulatory authorities;

根据全球主要监管机构的要求，制定证明设施和设备适用性/合格性的有效和可接受方法的原则、活动和可交付成果

• Improving the ability to consistently meet documented process requirements;

提高持续满足记录在案流程要求的能力

• Controlling risks within the manufacturing process;

控制生产制造过程中的风险；

• Producing high-quality products and consistent operation to meet product user requirements.

生产出高质量的产品和一致的操作，以满足用户对产品的要求。

• Guidance is provided on how to transition an organization's approach quality systems and establishing the appropriate of level of quality oversight for Commissioning and Qualification that incorporates a science and risk-based approach

就如何转变组织的方法质量体系，以及如何为包含科学和基于风险的方法的调试和确认建立适当的质量监督水平提供了指导。

模块

➡ "Fitness-For-Use" Qualification of the Commercial Manufacturing Process

商业生产制造工艺的"适用性"确认

➡User Requirements, Critical Aspects, and Critical Design Elements

用户需求、关键方面和关键设计要素

➡C&Q/ (Verification) Planning

C&Q/（确证）计划

➡System Classification

系统分类

➡GEP and the Engineering Quality Process (EQP)

GEP和工程质量流程（EQP）

➡Change Management

变更管理

➡Quality Risk Management (QRM)

质量风险管理（QRM）

➡Design Reviews / Design Qualification

设计审核/设计确认

➡Verification/(C&Q) Execution

确证/（C&Q）执行

➡Acceptance and Release

接受和发布

➡Vendor Audits

供应商审计

➡Good Documentation Practices for GEP

良好的GEP文档实践

➡Alignment with GAMP 5 for Process Control Systems

与过程控制系统GAMP 5保持一致

➡QRM C&Q Program Implementation and Legacy Systems

QRM C&Q计划实施和遗留系统

➡Composite Matrix for Requirement, Traceability, DQ and Testing

需求、可追溯性、DQ和测试的复合矩阵

谁应该参加

✅ Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.

希望了解和使用科学和基于风险的方法的调试和确认的中级从业人员。

✅Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

参与确认、验证和监管的项目工程师、项目经理、调试和验证专业人员、工程服务提供商以及质量保证人员。

Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E2500 ensures GMP facilities and equipment are "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle.

应用ICH Q9（质量风险管理）和ASTM E2500的原则，确保GMP设施和设备"适合使用"，性能令人满意，并可用于药品的生产、加工、包装和保存。本网络研讨会回顾了这种方法，并确定了制造系统的关键方面，这些方面将为确认/确证活动提供重点，并允许在整个项目生命周期中应用良好的工程/调试实践。

学习目标:

✅ Relate the ASTM Standard to GMP regulations and guidance documents

将ASTM标准与GMP法规和指导文件联系起来。

✅ Explain the regulatory foundation for the risk-based approach

解释基于风险的方法的监管基础

✅ Understand the 2019 ISPE Baseline® Guide: Commissioning and Qualification

了解2019 ISPE Baseline®指南：调试和确认

✅ Differentiate qualification versus verification

区分确认与确证

✅ Differentiate between the new risk assessment approach versus the old one

区分新旧风险评估方法

✅ Understand how the new USFDA Process Validation links to ASTM E2500

了解新的USFDA工艺验证如何与ASTM E2500相关联

✅ Understand the details on verification process flow

了解确证流程的详细信息

✅ Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)

通过C&Q流程实施确证（FAT、SAT、IV、FV、PT）

✅ Understand ways GEP can be used as a foundation for verification

了解如何将GEP作为验证的基础

✅ Understand the relationship between ICH Q9, ASTM E2500, and ISPE Baseline Guide, Volume 5, 2nd Edition: Commissioning and Qualification.

了解ICH Q9、ASTM E2500和ISPE基线指南第5卷第2版：调试和确认之间的关系。

✅ Discuss the information necessary to develop Requirements Documents that will support a science and risk-based approach to focus the qualification effort. Given the necessary information and a list of requirements, identify those that are necessary for product quality and those that are business/safety related.

讨论开发需求文档所需的信息，这些需求文档将支持基于科学和风险的方法，以专注于确认工作。给出必要的信息和要求清单，确定哪些是产品质量所必需的，哪些是业务/安全相关的。

✅ Apply risk management throughout the design and verification phases. Explain the link between risk assessments, design review, and quality risk management.

在整个设计和确证阶段应用风险管理。解释风险评估、设计审核和质量风险管理之间的联系。

✅ Understand and examine the development of a C&Q/Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.

了解并检查C&Q/确证策略的制定，该策略包括使用供应商测试、施工质量保证、现场验收测试、安装检查和功能测试。

✅ Know what is involved in a system Acceptance and Release report given requirements, critical aspects/critical design elements, and verification test results in compliance with a verification strategy.

根据验证策略，了解系统验收和发布报告中涉及的要求、关键方面/关键设计要素以及确证测试结果。

✅ Outline the use of GAMP® 5 principles in support of system delivery of a packaged system inclusive of mechanical and control system elements.

概述GAMP®5原则的使用，以支持包括机械和控制系统元件在内的成套系统的系统交付。

✅ Summarize US / EU / NMPA/ and WHO regulatory requirements and expectations that may influence application of a science and risk-based approach.

总结可能影响基于科学和风险的方法应用的美国/欧盟/NMPA/和世界卫生组织法规要求和期望。