1、Commissioning & Qualification Services Integrated into the Pharmaceutical Project Lifecycle 与制药工程项目全过程相整合的调试与确认服务Presented by Lu, Haorong 卢浩荣Reviewed by Henk Man Agenda议程 Introduction 导言 Definition and Contents Of I-C&Q ServiceI-C&Q服务的定义与内容 Services Provider and Stakeholders 服务提供商及相关方 Necessity必要性 I
2、mplementation 实施 References and Acknowledgements 参考文献与致谢2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Concepts 概念Good Engineering Practice良好工程规范Established engineering methods and standards that are applied throughout the project lifecycle to deliver appropriated cost-effective solution.在项目周期中全程采
3、用已建立的工程方法和标准，以交付合理的、经济有效的解决方案。Commissioning调试A well planned, documented and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the End-User that results in a safe and function environment that meets established design requirements and stakeholder expec
4、tations.采用一套良好计划的、有文件记录并受管理的工程方法，对工程设施、系统和设备进行试车并交付最终用户，以建立符合既定设计要求及股东期望的安全、功能良好的环境。2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Concepts (cont.)概念（续）DQ设计确认The documented verification that engineering design of a facility, utility or equipment that can affect product quality adhere to approved U
5、ser Requirement and design specifications. 对可能影响产品质量的设施、公用工程和设备的工程设计进行有文件记录的查证，确认与被批准的用户需求和设计描述一致。IQ安装确认 The documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications and are correctly installed. 对设施、公用工程和设备所有可能影响产品
6、质量的方面进行有文件记录的查证，确认与被批准的描述一致并已得到正确的安装。 2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Concepts (cont.)概念（续）OQ操作确认The documented verification that all aspects of a facility, utility, or equipment that can affect product quality operate as intended throughout all anticipated ranges. 对设施、公用工程和设备所有可能影响
7、产品质量的方面进行有文件记录的查证，确认它们在预期的操作极限内运行正确。PQ性能确认The documented verification that all aspects of facility, utility, or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria. 对设施、公用工程和设备所有可能影响产品质量的方面进行有文件记录的查证，确认其性能符合预先确定的验收标准。2012 ISPE CHINA ANNUAL CONFEREN
8、CEIntroduction 导言 Concepts (cont.)概念（续）PV工艺验证The process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. 建立文件证据，高度保证在特定生产工艺条件下，可均一地生产符合预定标准和质量属性
9、的产品的过程。More concepts 更多的概念 Risk Based Commensurate with risk 基于风险 与风险相适应 Science Based CQA, CPPs 基于科学 关键质量属性、关键工艺参数 Quality by Design Verify throughout 质量源于设计 全过程的验证 Subject Matter Expert Defined Role 学科问题专家 角色定义2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Current Issues Relative to C&Q in Chine
10、se Pharmaceutical Industry 当 前中国医药工业中调试与确认的相关问题 Limited resource and focus on DQ and QBD is not well acknowledged. 投入资源有限，对设计确认、质量源于设计等的重点未充分认识。 Very rare professional C&Q consultants aligned with international standard and practice. 专业的、与国际标准、规范接轨的调试与确认咨询服务提供商非常罕见。 Lack of local presence of interna
11、tional C&Q consulting expertise and the corresponding local professional engineer supportive team. 国际知名调试与确认专家罕有常驻中国本地，同时缺乏与其配套的本地专业工程师支持团队。 Importance of establishing a real QMS based on good C&Q practices is not well acknowledged by endorser top management. 以良好的调试与确认实践为基础建立一个真正的质量管理体系的重要性并未被企业高层管理
12、人员充分认识。2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Current Issues Relative to C&Q in Chinese Pharmaceutical Industry （ cont.） 当前中国医药工业中调试与确认的相关问题 （续） Seldom correct applications of risk assessment approach and over-interpreting of GMP regulations without understanding their rationales led to ov
13、erinvestment of the project. 风险分析方法罕有正确应用，未能从基本原理上进行理解，若干 GMP法规被过度解读导致项目过度投资。 Seldom systematic planning at the very beginning, most are crash jobs in the final phase of the project. 鲜有在项目开始即进行系统性的策划，大部分在项目后期进行突击。 Frequent change orders due to issues exposed in the final C&Q phase led to significant
14、 cost of remedy and delay. 因最终调试与确认阶段暴露的问题而产生的变更导致可观的索赔及工期延误。2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Current Issues Relative to C&Q in Chinese Pharmaceutical Industry （ cont.） 当前中国医药工业中调试与确认的相关问题 （续） Unclear interfaces and poor communications of the different project parties led to consider
15、able overlapping or missing of project works, commissioning integration with qualification is rare. 不同项目参与方节点不清，沟通不畅导致相当的项目工作重叠或漏项 , 罕有调试与确认进行整合。 Due to lack of specialized C&Q people, most of the C&Q jobs rely on sub-contractors or vendors, the jobs quality is not under control, and the owner or th
16、e EPC contractor has to pay extra charges for each equipment or system. 由于缺乏专业的调试与确认人员，大部分的调试与确认工作依赖于分包商或供应商，工作质量不可控，而业主或总承包商不得不为每一设备或系统付出额外的费用。2012 ISPE CHINA ANNUAL CONFERENCEIntroduction 导言 Current Issues Relative to C&Q in Chinese Pharmaceutical Industry （ cont.） 当前中国医药工业中调试与确认的相关问题 （续） Though s
17、everal Q&V consultants available, the scope and standards of works are undetermined, and therefore both quantity and quality of their works are hard to evaluate. 尽 管有数家确认与验证咨询服务提供商，但工作范围与标准不明确，因而工作的数量与质量都很难评估。 Due to absence of SME in some disciplines , the Q&V consultants sometimes can only reveal the defects in the project, but fail to present the cost-effective solutions for them, especially when the GMP conflicts with local codes, e.g. fire fighting or EHS codes. 由于某些专业的专家欠缺，确认与验证咨询服务提供商有时仅能揭示项目的某些缺陷，但不能给出相应的经济有效的解决方案，尤其是在 GMP与国内规范，如消防、环保、职业安全卫生规范发生冲突时。
