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回顾CTD历程，再读ICH M4，并译文以示虫友，欢迎雅正。已有17人参与
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回顾CTD历程，感触颇多，由照搬到理解，由学习到自己整理申报资料，从彷徨到笃定。一路走过，痛并快乐着。不经意的时光流逝，回头再看，山还是那座山。英文其实是我的缺陷，但是在翻译的时候领悟很多，感慨万千。其中真意，尽在不言。不妨将自译稿件以示虫友，不当之处敬请指正。 ICH M4 CTD 模块2和3 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY 人用药品注册的通用技术文件： MODULE 2： QUALITY OVERALL SUMMARY 模块2：质量综述 MODULE 3 : QUALITY 模块3：质量 ICH HARMONISED TRIPARTITE GUIDELINE ICH协调的三方指南TABLE OF CONTENTS 目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 模块2：通用技术文件综述 2.3 : QUALITY OVERALL SUMMARY (QOS)质量综述（QOS） INTRODUCTION 介绍 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药（名称，制造商） 2.3.S.1 General Information (name, manufacturer) 一般信息 2.3.S.2 Manufacture (name, manufacturer)生产信息 2.3.S.3 Characterisation (name, manufacturer) 特性 2.3.S.4 Control of Drug Substance (name, manufacturer)质量控制 2.3.S.5 Reference Standards or Materials (name, manufacturer) 标准品或对照品 2.3.S.6 Container Closure System (name, manufacturer) 包材信息 2.3.S.7 Stability (name, manufacturer) 稳定性 MODULE 3 : QUALITY 模块3：质量 3.1.TABLE OF CONTENTS OF MODULE 3 模块3目录 3.2. BODY OF DATA主体数据 3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)原料药（名称，制造商） 3.2.S.1 General Information (name, manufacturer)一般信息 3.2.S.1.1 Nomenclature (name, manufacturer) 命名 3.2.S.1.2 Structure (name, manufacturer) 结构 3.2.S.1.3 General Properties (name, manufacturer) 一般性质 3.2.S.2 Manufacture (name, manufacturer) 生产 3.2.S.2.1 Manufacturer(s) (name, manufacturer) 制造商 3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer)制造工艺和工艺控制的叙述 3.2.S.2.3 Control of Materials (name, manufacturer) 物料的控制 3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)关键步骤和中间体的控制 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)工艺验证和/或评估 3.2.S.2.6 Manufacturing Process Development (name, manufacturer)制造工艺开发 3.2.S.3 Characterisation (name, manufacturer) 特性 3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer结构和其它特性的阐明 3.2.S.3.2 Impurities (name, manufacturer) 杂质 3.2.S.4 Control of Drug Substance (name, manufacturer) 原料药的控制 3.2.S.4.1 Specification (name, manufacturer) 质量标准 3.2.S.4.2 Analytical Procedures (name, manufacturer) 分析方法 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)分析方法的验证 3.2.S.4.4 Batch Analyses (name, manufacturer)检测报告 3.2.S.4.5 Justification of Specification (name, manufacturer) 质量标准建立依据 3.2.S.5 Reference Standards or Materials (name, manufacturer)标准品或对照品 3.2.S.6 Container Closure System (name, manufacturer) 包材 3.2.S.7 Stability (name, manufacturer) 稳定性 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 稳定性总结 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer)上市后的稳定性方案和稳定性承诺 3.2.S.7.3 Stability Data (name, manufacturer)稳定性数据 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES模块2：通用技术文件综述 2.3 : QUALITY OVERALL SUMMARY (QOS)2.3：质量综述(QOS) The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. 质量综述（QOS）由模块3中主体数据的范围和要点产生的概述。QOS不应包含模块3或CTD其它的部分中未包含的信息，数据或论证。 The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of Module 3. The QOS should also emphasise critical key parameters of the product and provide, for instance, justification in cases where guidelines were not followed. The QOS should include a discussion of key issues that integrates information from sections in the Quality Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies discussed under the CTD-S module), including cross-referencing to volume and page number in other Modules. QOS应包含每一部分的足够信息以提供给质量审核者模块3综述。QOS也应强调产品的关键参数，如，提供论证指南未被遵循的情况。QOS应包含对关键问题的讨论，这些讨论整合了来自质量模块章节的信息，及其它模块的辅助信息。（如，在CTD-S模块中讨论的，经由毒理研究杂质的界定），包括相互参照其它模块的容量和页码。 This QOS normally should not exceed 40 pages of text, excluding tables and figures. For biotech products and products manufactured using more complex processes, the document could be longer but normally should not exceed 80 pages of text (excluding tables and figures). QOS通常不应有超过40页的正文（不包括表格和图片）。对于生化产品和采用较复杂工艺制造的产品，文件的正文可以长点通常不应超过80页（不包括表格和图片）。 The italicised text below indicates where tables, figures, or other items can be imported directly from Module 3表格，图片或其他重要内容下面的文字可以以斜体字体从模块3中直接导入引用。 INTRODUCTION 介绍 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)原料药 2.3.S.1 General Information (name, manufacturer) 一般信息 Information from 3.2.S.1 should be included. 应包含3.2.S.1中的信息 The introduction should include proprietary name, non-proprietary name or common name of the drug substance, company name, dosage form(s), strength(s), route of administration, and proposed indication(s)包含原料药的专用名称，非专用名或通用名，公司名，剂型（多个），剂量（多个），给药途径，和拟定适应症（多个）。 2.3.S.2 Manufacture (name, manufacturer) 2.3.S.2 生产信息 Information from3.2.S.2 should be included: 应包含3.2.S.2中的的信息 Information on the manufacturer生产信息； A brief description of the manufacturing process (including, for example, reference to starting materials, critical steps, and reprocessing) and the controls that are intended to result in the routine and consistent production of material(s) of appropriate quality;制造过程（如，包括参考起始物料，关键步骤，和重处理）和旨在常规地，持续地生产出合格质量的物料的控制的简明叙述。A flow diagram, as provided in 3.2.S.2.2;如3.2.S.2.2提供的流程图； A description of the Source and Starting Material and raw materials of biological origin used in the manufacture of the drug substance, as described in 3.2.S.2.3;包含在3.2.S.2.3中叙述原料药制造工程中使用的起始原料和生物用品的来源。 A discussion of the selection and justification of critical manufacturing steps, process controls, and acceptance criteria. Highlight critical process intermediates, as described in 3.2.S.2.4;关键生产步骤，工艺控制；关键中间体，控制标准的选择和论证，包含在3.2.S.2.4中的叙述。 A description of process validation and/or evaluation, as described in 3.2.S.2.5. 描述在3.2.S.2.5.中叙述的工艺验证和/或评估。 A brief summary of major manufacturing changes made throughout development and conclusions from the assessment used to evaluate product consistency, as described in 3.2.S.2.6. 在3.2.S.2.6中用于评估产品连贯性的评估结论的药品开发过程，主要变更的概述。 The QOS should also cross-refer to the non-clinical and clinical studies that used batches affected by these manufacturing changes, as provided in the CTD-S and CTD-E modules of the dossier.。QOS也应交叉指出生产变更批次对非临床的和临床影响的研究，参考在申请文件中CTD-S和CTD-E模板。 2.3.S.3 Characterisation (name, manufacturer)特性 For NCE: 对新化学实体： A summary of the interpretation of evidence of structure and isomerism, as described in 3.2.S.3.1, should be included. 在3.2.S.3.1中应包括对结构和异构现象存在诠释的概述。 When a drug substance is chiral, it should be specified whether specific stereoisomers or a mixture of stereoisomers have been used in the nonclinical and clinical studies, and information should be given as to the stereoisomer of the drug substance that is to be used in the final product intended for marketing. 当原料药具有手性，应详细说明是否单一异构体或消悬体在非临床和临床研究使用，将用处最后拟销售制剂的原料药的异构体的信息应给出。 For NCE and Biotech: 对新化学实体和生物技术产品 The QOS should summarise the data on potential and actual impurities arising from the synthesis, manufacture and/or degradation, and should summarise the basis for setting the acceptance criteria for individual and total impurities. The QOS should also summarise the impurity levels in batches of the drug substance used in the non-clinical studies, in the clinical trials, and in typical batches manufactured by the proposed commercial process. The QOS should state how the proposed impurity limits are qualified. QOS应概述在合成，制造和/或降解中产生的潜在的和实际存在的杂质数据。应概述设定单个和总和杂质认可标准的基础。QOS也应概述用于非临床研究，临床实验的原料药批次中以及拟上市工艺制造的典型批次的杂质水平。QOS应注明拟定的杂质限度是如何限定的。 A tabulated summary of the data provided in 3.2.S.3.2, with graphical representation, where appropriate should be included. 包含3.2.S.3.2中提供的数据的表格概要，适当的图示。 2.3.S.4 Control of Drug Substance (name, manufacturer) 原料药控制 A brief summary of the justification of the specification(s), the analytical procedures, and validation should be included. 包含对质量标准，分析方法和验证的简明概述。 Specification from 3.2.S.4.1 should be provided.在 3.2.S.4.1提供的质量标准应 A tabulated summary of the batch analyses from 3.2.S.4.4, with graphical representation where appropriate, should be provided. 3.2.S.4.4中应提供批次的分析数据的表格、图。 2.3.S.5 Reference Standards or Materials (name, manufacturer) 2.3.S.5 标准品或对照品 Information from 3.2.S.5 (tabulated presentation, where appropriate) should be included.3.2.S.5中包含的对照品或标准品的信息（适当的表格形式给出）。 2.3.S.6 Container Closure System (name, manufacturer) 2.3.S.6 包材 A brief description and discussion of the information, from 3.2.S.6 should be included. 应包含3.2.S.6中信息的简明说明和讨论。 2.3.S.7 Stability (name, manufacturer) 2.3.S.7 稳定性 This section should include a summary of the studies undertaken (conditions, batches, analytical procedures) and a brief discussion of the results and conclusions, the proposed storage conditions, retest date or shelf-life, where relevant, as described in 3.2.S.7.1. 这一部分应包含所做的稳定性概述（条件，批次，分析方法）和对结果和结论的简明讨论，拟定的储存条件，复测期或货架寿命，如3.2.S.7.1.叙述的相关内容 The post-approval stability protocol, as described in 3.2.S.7.2, should be included. 应包含3.2.S.7.2中叙述的，批准后的稳定性方案。 A tabulated summary of the stability results from 3.2.S.7.3, with graphical representation where appropriate, should be provided. 应提供3.2.S.7.3中稳定性结果的表格概述，适当地附上图谱。 MODULE 3 : QUALITY 模块3：质量 SCOPE OF THE GUIDELINE 指南导读 This document is intended to provide guidance on the format of a registration application for drug substances and their corresponding drug products as defined in the scope of the ICH Guidelines Q 6 A ("NCE"  and ICH Guideline Q 6 B ("Biotech". This format may also be appropriate for certain other categories of products. To determine the applicability of this format for a particular type of product, applicants should consult with the appropriate regulatory authorities. 本文件旨在对ICH指南Q6A（“新化合物实体”）和ICH指南Q6B（生物技术产品）范围内的原料药和对应的制剂的注册申请的格式提供指南。此格式也可以适用于某些其它种类的产品。为确定此格式是否适用于特定类型的产品，申请者应和相应的管理部门咨询。The text following the section titles is intended to be explanatory and illustrative only. The content of these sections should include relevant information described in existing ICH guidelines, but harmonised content is not available for all sections. The "Body of Data" in this guideline merely indicates where the information should be located. Neither the type nor extent of specific supporting data has been addressed in this guideline, and both may depend upon regional guidance. 各部分标题下的正文旨在用于解释和说明。这些章节的内容应包含现ICH指南中叙述的相关信息，但对整个章节都获得一致可行的内容并不可行。本指南中的“主体数据”仅表明信息应放在何处。具体的支持性数据的类型和程度都未发表在本指南中，但它们都应根据各个区域的指南。 The section titles of Part 3.2.R (Regional Information) represent examples of typical topics of information that are not common to all ICH regions. Hence, the information to be provided in these sections should be based on the relevant regional guidelines. 3.2.R部分的章节标题（地区的信息）代表了不通用于所有ICH区域典型话题信息的例子。因此，在这些章节中待提供的信息应基于相关的地区性指南。 3.1. TABLE OF CONTENTS OF MODULE 3 3.1. 模块3目录 A Table of Contents for the filed application should be provided. 应提供申请文件的目录 3.2. BODY OF DATA 3.2. 主体数据 3.2.S DRUG SUBSTANCE1 (NAME, MANUFACTURER) 3.2.S 原料药 3.2.S.1 General Information (name, manufacturer) 3.2.S.1 一般信息 3.2.S.1.1 Nomenclature (name, manufacturer) 3.2.S.1.1 命名 Information on the nomenclature of the drug substance should be provided. For example: Recommended International Nonproprietary Name (INN); Compendial name if relevant; Chemical name(s); Company or laboratory code; Other non-proprietary name(s), e.g., national name, United States Adopted Name (USAN), Japanese Accepted Name (JAN); British Approved Name (BAN), and Chemical Abstracts Service (CAS) registry number. 应提供原料药命名的信息，如建议的国际通用名（INN），相关的药典名，化学名，公司或实验室代码，其它的通用名，如本国名，美国采用的名称，日本认可的名称，英国批准的名称，以及CAS登记号。 3.2.S.1.2 Structure (name, manufacturer) 3.2.S.1.2 结构 NCE: The structural formula, including relative and absolute stereochemistry, the molecular formula, and the relative molecular mass should be provided. 新化学实体应提供包括相对的和绝对的立体化学的结构式，分子式和相对的分子量。 3.2.S.1.3 General Properties (name, manufacturer)3.2.S.1.3 一般性质 A list should be provided of physicochemical and other relevant properties of the drug substance, including biological activity for Biotech. 应提供原料药的物理化学的或其它相关性质的列表，包括生物技术产品的生物活性。 Reference ICH Guidelines: Q6A and Q6B 参考ICH指南：Q6A和 Q6B 。 3.2.S.2 Manufacture (name, manufacturer)3.2.S.2 生产信息 3.2.S.2.1 Manufacturer(s) (name, manufacturer) 3.2.S.2.1 制造商 The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing should be provided. 应提供生产商的名称，地址、职责。包括承包商，以及生产和检测中涉及的每一个拟定的生产场地或设施。 3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 3.2.S.2.2 生产工艺和工艺控制的叙述 The description of the drug substance manufacturing process represents the applicant’s commitment for the manufacture of the drug substance. Information should be provided to adequately describe the manufacturing process and process controls. For example: NCE: A flow diagram of the synthetic process(es) should be provided that includes molecular formulae, weights, yield ranges, chemical structures of starting materials, intermediates, reagents and drug substance reflecting stereochemistry, and identifies operating conditions and solvents. 原料药生产工艺的叙述代表了申请者对原料药制造的承诺。应提供信息以准确地描述制造工艺和工艺控制。如：新分子实体应提供合成工艺的一个（或多个）流程图，包括分子式，重量，产率范围。起始原料、中间体、试剂和原料药的化学结构和立体结构，确定操作条件和溶剂。 A sequential procedural narrative of the manufacturing process should be submitted. The narrative should include, for example, quantities of raw materials, solvents, catalysts and reagents reflecting the representative batch scale for commercial manufacture, identification of critical steps, process controls, equipment and operating conditions (e.g., temperature, pressure, pH, time).应递交生产工艺的连续的程序性叙述。如，叙述应包含可以反映商业生产的批次规模的原材料，溶剂，催化剂和反应物的量，确定的关键步骤，工艺控制，设备和操作条件（如，温度，压力，pH,时间）。 Alternate processes should be explained and described with the same level of detail as the primary process. Reprocessing steps should be identified and justified. Any data to support this justification should be either referenced or filed in 3.2.S.2.5. 应和主要工艺同等详细程度地解释和叙述可供替换的工艺；重处理步骤需要确定并合理。用于支持论证的数据可以在3.2.S.2.5.中阐述。 3.2.S.2.3 Control of Materials (name, manufacturer)3.2.S.2.3 物料的控制 Materials used in the manufacture of the drug substance (e.g., raw materials, starting materials, solvents, reagents, catalysts) should be listed identifying where each material is used in the process. Information on the quality and control of these materials should be provided. Information demonstrating that materials (including biologically-sourced materials, e.g., media components, monoclonal antibodies, enzymes) meet standards appropriate for their intended use (including the clearance or control of adventitious agents) should be provided, as appropriate. For biologically-sourced materials, this can include information regarding the source, manufacture, and characterisation. (Details in 3.2.A.2 for both NCE and Biotech) .Reference ICH Guidelines: Q6A and Q6B列出原料药生产中使用的物料（如，原料，起始物料，溶剂，反应物，催化剂）的清单，标明每一原料使用在工艺中的哪里。应提供这些物料的质量和控制的信息。恰当地说明物料（包括生物来源的物料，如媒介组分，单克隆抗体，酶）满足指定用途（包括外来试剂的清除或控制）的标准。对于生物来源的物料，包含关于来源，生产和特性的信息。详见3.2.A.2）参考ICH指南：Q6A 和 Q6B 3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 3.2.S.2.4 关键步骤和中间体的控制 Critical Steps: Tests and acceptance criteria (with justification including experimental data) performed at critical steps identified in 3.2.S.2.2 of the manufacturing process to ensure that the process is controlled should be provided. 关键步骤：应提供在关键步骤（等同于3.2.S.2.2制造工艺）进行检测和确定认可标准（包含实验数据的论证）以确定工艺得到了控制。 Intermediates: Information on the quality and control of intermediates isolated during the process should be provided. Reference ICH Guidelines: Q6A and Q6B 参考ICH 指南：Q6A and Q6B 中间体：应提供工艺中分离的中间体的质量和控制的信息。 Additionally for Biotech: Stability data supporting storage conditions should be provided. 此外对生物技术产品：应提供用于支持储存条件的的稳定性数据。 Reference ICH Guideline: Q5C 参考ICH指南：Q5C 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) 3.2.S.2.5 工艺验证和/或评估 Process validation and/or evaluation studies for aseptic processing and sterilisation should be included. 应包含无菌操作和灭菌的工艺验证和/或评估 3.2.S.2.6 Manufacturing Process Development (name, manufacturer) 3.2.S.2.6 生产工艺的开发 NCE: A description and discussion should be provided of the significant changes made to the manufacturing process and/or manufacturing site of the drug substance used in producing nonclinical, clinical, scale-up, pilot, and, if available, production scale batches. Reference should be made to the drug substance data provided in section 3.2.S.4.4. Reference ICH Guideline: Q3A新化学实体：应提供用于非临床的，临床的，放大规模的，中试的，可得的大生产批次的原料药的制造工艺和/或制造地点显著变更。 应涉及3.2.S.4.4.中原料药批次数据。参考ICH指南：Q3A 3.2.S.3 Characterisation (name, manufacturer) 3.2.S.3 特性 3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) 3.2.S.3.1 结构和其它性质的阐明 NCE: Confirmation of structure based on e.g., synthetic route and spectral analyses should be provided. Information such as the potential for isomerism, the identification of stereochemistry, or the potential for forming polymorphs should also be included. 新化学实体：应提供基于，如，合成路线和光谱分析的结构确认。潜在异构体，立体化学的识别，或潜在形成多晶型的信息。 Reference ICH Guideline: Q6A 参考ICH指南：Q6A 3.2.S.3.2 Impurities (name, manufacturer) 3.2.S.3.2 杂质 Information on impurities should be provided. Reference ICH Guidelines: Q3A, Q3C, Q5C, Q6A, and Q6B.应提供杂质的信息。参考ICH指南：Q3A, Q3C, Q5C, Q6A, and Q6B 3.2.S.4 Control of Drug Substance (name, manufacturer) 3.2.S.4 原料药控制 3.2.S.4.1 Specification (name, manufacturer)3.2.S.4.1 质量标准 The specification for the drug substance should be provided. Reference ICH Guidelines: Q6A and Q6B应提供原料药的质量标准。参考ICH指南：Q6A 和 Q6B 3.2.S.4.2 Analytical Procedures (name, manufacturer)3.2.S.4.2 分析方法 The analytical procedures used for testing the drug substance should be provided. 应提供用于检测原料药的分析方法 Reference ICH Guidelines: Q2A and Q6B 参考ICH指南：Q2A 和 Q6B 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) 3.2.S.4.3 分析方法的验证 Analytical validation information, including experimental data for the analytical procedures used for testing the drug substance, should be provided. Reference ICH Guidelines: Q2A, Q2B, and Q6B. 应提供分析验证信息，包括用于检测原料药的分析方法的实验数据。参考ICH指南：Q2A, Q2B, and Q6B 3.2.S.4.4 Batch Analyses (name, manufacturer)3.2.S.4.4 分析报告 Description of batches and results of batch analyses should be provided. Reference ICH Guidelines: Q3A, Q3C, Q6A, and Q6B. 应提供批次及批次分析的结果的叙述。参照ICH指南：Q3A, Q3C, Q6A, and Q6B。 3.2.S.4.5 Justification of Specification (name, manufacturer) 3.2.S.4.5 质量标准制定依据 Justification for the drug substance specification should be provided. Reference ICH Guidelines: Q3A, Q3C, Q6A and Q6B. 应提供原料药质量标准的制定依据。参照ICH指南：Q3A, Q3C, Q6A and Q6B。 3.2.S.5 Reference Standards or Materials (name, manufacturer)3.2.S.5 标准品或对照品 Information on the reference standards or reference materials used for testing of the drug substance should be provided. Reference ICH Guidelines: Q6A and Q6B. 应提供用于检测原料药的标准品或对照品的信息。参照ICH指南：Q6A 和 Q6B 3.2.S.6 Container Closure System (name, manufacturer)3.2.S.6 包材 A description of the container closure system(s) should be provided, including the identity of materials of construction of each primary packaging component, and their specifications. The specifications should include description and identification (and critical dimensions with drawings, where appropriate). Non-compendial methods (with validation) should be included, where appropriate. 应提供包材的叙述，包括每一个主要包装成分构成材料以及它们的质量标准。质量标准应包含叙述和鉴定（适当的标明主要尺寸的图片）。包括非药典方法（需验证）。 For non-functional secondary packaging components (e.g., those that do not provide additional protection), only a brief description should be provided. For functional secondary packaging components, additional information should be provided. The suitability should be discussed with respect to, for example, choice of materials, protection from moisture and light, compatibility of the materials of construction with the drug substance, including sorption to container and leaching, and/or safety of materials of construction. 对于非功能的第二层包装成分（如，那些并不提供其他的保护），仅仅需提供简明的叙述。对于实用的第二层包装组分，应提供进一步的信息。应根据，如物料的选择，湿度和光的防护，构成的材料和原料药的兼容性，包括对容器的吸收作用和沥滤，和/或组成材料的安全性。 3.2.S.7 Stability (name, manufacturer) 3.2.S.7 稳定性 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 3.2.S.7.1 稳定性概述和结论 The types of studies conducted, protocols used, and the results of the studies should be summarized. The summary should include results, for example, from forced degradation studies and stress conditions, as well as conclusions with respect to storage conditions and retest date or shelf-life, as appropriate. Reference ICH Guidelines: Q1A, Q1B, and Q5C. 应概述所作研究的内容、方案和研究的结果。如，概述应包含强降解研究的结果和强降解条件。以及关于储存条件和复测期或货架寿命的结论。参照ICH指南：Q1A, Q1B, 和 Q5C。 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) 3.2.S.7.2 批准后的稳定性方案和稳定性承诺 The post-approval stability protocol and stability commitment should be provided. Reference ICH Guidelines: Q1A and Q5C. 应提供批准后稳定性方案和稳定性承诺。参考ICH指南：Q1A and Q5C。 3.2.S.7.3 Stability Data (name, manufacturer) 3.2.S.7.3 稳定性数据 Results of the stability studies (e.g., forced degradation studies and stress conditions) should be presented in an appropriate format such as tabular, graphical, or narrative. Information on the analytical procedures used to generate the data and validation of these procedures should be included. Reference ICH Guidelines: Q1A, Q1B, Q2A, Q2B, and Q5C. 以恰当的格式，如表格，图表，或陈述给出稳定研究的结果（如，强降解研究和强降解条件）。用于产生数据的分析方法的信息以及这些方法的验证应包含在内。参考ICH指南：Q1A, Q1B, Q2A, Q2B, 和 Q5C。 |
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