PDATR-29清洁验证中英对照(序&目录)
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2. The Cleaning Continuum 清洁操作的连贯性 2.1 Use of the Cleaning Continuum 清洁操作连贯性的运用 2.2 Cleaning Program Criteria 清洁程序标准 Automated Cleaning——Manual Cleaning 自动清洁——手工清洁. . . . . . . . . . . . . . 5 Clean-In-Place (CIP)——Clean-Out-of-Place (COP) 在线清洗——离线清洗 2.3 Equipment Characteristics / Materials of Construction 设备特色与构造材质 Dedicated—— Non-Dedicated Manufacturing Equipment 专用——非专用生产设备 Dedicated—— Non-Dedicated Cleaning Equipment 专用——非专用清洁设备 Non-Product Contact——Product Contact Surfaces 非产品接触——产品接触表面 Non-Critical Site—— Critical Site 非关键位置——关键位置 Minor Equipment——Major Equipment
Our goal had always been to outline cleaning validation practices across a range of equipment, process, and product applications and the inclusion of this flexibility was certainly a factor in the length of time it took to complete this effort. During the course of assembling this document, we recognized the commonality of certain themes, issues, and concerns relative to cleaning and cleaning validation across the industry. We also realized that in order to apply the principles in different operating settings, that some narrowing of the document would be necessary. As a result, we have included perspectives on the application of the guidance in various areas: finished pharmaceuticals, bulk pharmaceutical chemicals, biopharmaceuticals and clinical products. Inclusion of biopharmaceuticals in this effort is not intended to replace the more comprehensive coverage provided by our partner committee, but rather to provide greater insight regarding the broad application of the guidance provided herein. 我们的目标一直都是着眼于如何描述清洁验证的操作，以适应一系列设备、工艺及产品 的应用，另外，在完成本工作之前耗时不少，是以运作的弹性度也自然的进行了考虑。 在编制本文件的过程中，我们了解工业界在清洁方法与清洁验证方面若干共同的主题、 争议及关注点。我们也知道如要讲相关的原则用于不同的现状，本文件中有些部分涉及 的内容有必要加以量化的必要。基于这些原因，我们对本文件在各种领域方面的应用， 如一般制剂、原料药、生物制剂及临床有关产品等，分别加以研究描述。生物药学制剂 的列入，目的不在于取代我们的队友已提供的较为广泛而深入的资料，而在于本资料更 能令人深入了解，以使其广泛的应用。
3.5 Cleaning Agent Groupings 清洁剂分类
4. Residues and Residue Removal 残留物与残留物的清除
4.1 Types of Residue 残留物的类别
4.2 Cleaning Agents
清洁剂
4.3 Microbiological Contaminants 微生物污染
Russell E. Madsen Chairman, Pharmaceutical Cleaning Validation Task Force
制药清洁验证工作小组主席
Table of Contents
目录
1. Introduction 简介 1.1 Background 背景 1.2 Purpose 目的 1.3 Scope 范围 1.4 Report Organization 本报告的组织架构 Finished Pharmaceuticals 制剂 Biopharmaceuticals 生物制品 Bulk Pharmaceutical Chemicals 原料药 Clinical Products 临床试验用品
This Technical Report was disseminated in draft for public review and comment prior to publication. Many of the submitted comments have been included in the final document. We
来自百度文库
believe this approach accomplished the widest possible review of the document and ensures its suitability as a valuable guide to industry in the area of cleaning validation. This document should be considered as a guide; it is not intended to establish any mandatory or implied standard. 在出版之前，本技术报告的草案曾经过公众的讨论与建议；许多建议都已并入本最终文 件中。我们相信这广征意见的处理方式能使本文件成为制药工业在清洁确认方面游泳的 指导。本文件应被视为是一种指南，其内容并非强制性，不在于强制或暗示的标准。
3. Cleaning Validation 清洁验证
3.1 The Cleaning Validation Program 清洁验证程序
3.2 Product Grouping 产品分类
3.3 Manufacturing Equipment Grouping 生产设备分类
3.4 Cleaning Method Groupings 清洁方法分类
次要设备——主要设备 Materials of Construction 构造材质 2.4 Product Attributes 产品属性 Low Risk——High Risk Drugs 低风险——高风险药物 Highly Characterized——Poorly Characterized 高度特性化——缺乏特性化 Non-Sterile——Sterile 非无菌——无菌 2.5 Formulation Attributes 配方属性 Solids——Liquids 固体——液体 Soluble (Active or Excipient)——Insoluble (Active or Excipient) 可溶活性成分或赋形剂——难溶活性成分或赋形剂 2.6 Operational Issues 操作上的问题 Single Product Facility——Multiple Product Facility 单品种设施——多品种设施 Campaign Production——Batch Production 连续生产——批次生产 Simple Equipment Train——Complex Equipment Train 简单设备组合——复杂设备组合
Preface
序
This document provides guidance relative to the validation of cleaning for a broad range of processing systems and product types within the pharmaceutical industry. This effort commenced in 1991 in conjunction with individuals representing the biotechnology community. Early on it was agreed to separate the development of cleaning validation guidance into "biotechnology" and "pharmaceutical" segments. The committees worked in parallel for a number of years and shared early drafts to ensure that what would be produced by each committee would be compatible. The biotech effort culminated in PDA's 1995 publication of "Cleaning and Cleaning Validation: A Biotechnology Perspective". The "pharmaceutical" committee continued the development of its document after the publication of the biotech effort, and completed its stand alone guidance in the fall of 1997. 本文件旨在作为制药设备清洁验证的指南，以配合制药工业中范围宽广的生产系统及产 品类型。本小组自1991年起致力于本文件的撰写，当时开始与生物技术工作人员共同工 作。工作初期，大家认同把清洁验证的研究按“生物科技”和“制药”区分处理；在数 年间两组人员平行进行相关的开发工作，并相互共享初期所拟定的草案，以保证两方面 意见相同的事项。PDA于1995年将“生物技术”方面的研究所得出版为"Cleaning and Cleaning Validation: A Biotechnology Perspective"。制药方面的研究小组随后继续研究， 于1997年秋季完成起研究工作。
4.4 Other Contaminants to be Removed 其他应清除的微生物
4.5 Cleaning Agent and Surface Interactions 清洁剂与表面直接的相互作用
5. Cleaning of Equipment 设备的清洗
5.1 Types of Cleaning Processes 清洗程序的类型 Manual 手工 Semi-Automated 半自动 Automated 全自动
Our goal had always been to outline cleaning validation practices across a range of equipment, process, and product applications and the inclusion of this flexibility was certainly a factor in the length of time it took to complete this effort. During the course of assembling this document, we recognized the commonality of certain themes, issues, and concerns relative to cleaning and cleaning validation across the industry. We also realized that in order to apply the principles in different operating settings, that some narrowing of the document would be necessary. As a result, we have included perspectives on the application of the guidance in various areas: finished pharmaceuticals, bulk pharmaceutical chemicals, biopharmaceuticals and clinical products. Inclusion of biopharmaceuticals in this effort is not intended to replace the more comprehensive coverage provided by our partner committee, but rather to provide greater insight regarding the broad application of the guidance provided herein. 我们的目标一直都是着眼于如何描述清洁验证的操作，以适应一系列设备、工艺及产品 的应用，另外，在完成本工作之前耗时不少，是以运作的弹性度也自然的进行了考虑。 在编制本文件的过程中，我们了解工业界在清洁方法与清洁验证方面若干共同的主题、 争议及关注点。我们也知道如要讲相关的原则用于不同的现状，本文件中有些部分涉及 的内容有必要加以量化的必要。基于这些原因，我们对本文件在各种领域方面的应用， 如一般制剂、原料药、生物制剂及临床有关产品等，分别加以研究描述。生物药学制剂 的列入，目的不在于取代我们的队友已提供的较为广泛而深入的资料，而在于本资料更 能令人深入了解，以使其广泛的应用。
3.5 Cleaning Agent Groupings 清洁剂分类
4. Residues and Residue Removal 残留物与残留物的清除
4.1 Types of Residue 残留物的类别
4.2 Cleaning Agents
清洁剂
4.3 Microbiological Contaminants 微生物污染
Russell E. Madsen Chairman, Pharmaceutical Cleaning Validation Task Force
制药清洁验证工作小组主席
Table of Contents
目录
1. Introduction 简介 1.1 Background 背景 1.2 Purpose 目的 1.3 Scope 范围 1.4 Report Organization 本报告的组织架构 Finished Pharmaceuticals 制剂 Biopharmaceuticals 生物制品 Bulk Pharmaceutical Chemicals 原料药 Clinical Products 临床试验用品
This Technical Report was disseminated in draft for public review and comment prior to publication. Many of the submitted comments have been included in the final document. We
来自百度文库
believe this approach accomplished the widest possible review of the document and ensures its suitability as a valuable guide to industry in the area of cleaning validation. This document should be considered as a guide; it is not intended to establish any mandatory or implied standard. 在出版之前，本技术报告的草案曾经过公众的讨论与建议；许多建议都已并入本最终文 件中。我们相信这广征意见的处理方式能使本文件成为制药工业在清洁确认方面游泳的 指导。本文件应被视为是一种指南，其内容并非强制性，不在于强制或暗示的标准。
3. Cleaning Validation 清洁验证
3.1 The Cleaning Validation Program 清洁验证程序
3.2 Product Grouping 产品分类
3.3 Manufacturing Equipment Grouping 生产设备分类
3.4 Cleaning Method Groupings 清洁方法分类
次要设备——主要设备 Materials of Construction 构造材质 2.4 Product Attributes 产品属性 Low Risk——High Risk Drugs 低风险——高风险药物 Highly Characterized——Poorly Characterized 高度特性化——缺乏特性化 Non-Sterile——Sterile 非无菌——无菌 2.5 Formulation Attributes 配方属性 Solids——Liquids 固体——液体 Soluble (Active or Excipient)——Insoluble (Active or Excipient) 可溶活性成分或赋形剂——难溶活性成分或赋形剂 2.6 Operational Issues 操作上的问题 Single Product Facility——Multiple Product Facility 单品种设施——多品种设施 Campaign Production——Batch Production 连续生产——批次生产 Simple Equipment Train——Complex Equipment Train 简单设备组合——复杂设备组合
Preface
序
This document provides guidance relative to the validation of cleaning for a broad range of processing systems and product types within the pharmaceutical industry. This effort commenced in 1991 in conjunction with individuals representing the biotechnology community. Early on it was agreed to separate the development of cleaning validation guidance into "biotechnology" and "pharmaceutical" segments. The committees worked in parallel for a number of years and shared early drafts to ensure that what would be produced by each committee would be compatible. The biotech effort culminated in PDA's 1995 publication of "Cleaning and Cleaning Validation: A Biotechnology Perspective". The "pharmaceutical" committee continued the development of its document after the publication of the biotech effort, and completed its stand alone guidance in the fall of 1997. 本文件旨在作为制药设备清洁验证的指南，以配合制药工业中范围宽广的生产系统及产 品类型。本小组自1991年起致力于本文件的撰写，当时开始与生物技术工作人员共同工 作。工作初期，大家认同把清洁验证的研究按“生物科技”和“制药”区分处理；在数 年间两组人员平行进行相关的开发工作，并相互共享初期所拟定的草案，以保证两方面 意见相同的事项。PDA于1995年将“生物技术”方面的研究所得出版为"Cleaning and Cleaning Validation: A Biotechnology Perspective"。制药方面的研究小组随后继续研究， 于1997年秋季完成起研究工作。
4.4 Other Contaminants to be Removed 其他应清除的微生物
4.5 Cleaning Agent and Surface Interactions 清洁剂与表面直接的相互作用
5. Cleaning of Equipment 设备的清洗
5.1 Types of Cleaning Processes 清洗程序的类型 Manual 手工 Semi-Automated 半自动 Automated 全自动