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回顧CTD歷程，再讀ICH M4，并譯文以示蟲友，歡迎雅正。 已有17人參與
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回顧CTD歷程，感觸頗多，由照搬到理解，由學(xué)習(xí)到自己整理申報資料，從彷徨到篤定。一路走過，痛并快樂著。不經(jīng)意的時光流逝，回頭再看，山還是那座山。英文其實是我的缺陷，但是在翻譯的時候領(lǐng)悟很多，感慨萬千。其中真意，盡在不言。不妨將自譯稿件以示蟲友，不當(dāng)之處敬請指正。 ICH M4 CTD 模塊2和3 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY 人用藥品注冊的通用技術(shù)文件： MODULE 2： QUALITY OVERALL SUMMARY 模塊2：質(zhì)量綜述 MODULE 3 : QUALITY 模塊3：質(zhì)量 ICH HARMONISED TRIPARTITE GUIDELINE ICH協(xié)調(diào)的三方指南TABLE OF CONTENTS 目錄 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 模塊2：通用技術(shù)文件綜述 2.3 : QUALITY OVERALL SUMMARY (QOS)質(zhì)量綜述（QOS） INTRODUCTION 介紹 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料藥（名稱，制造商） 2.3.S.1 General Information (name, manufacturer) 一般信息 2.3.S.2 Manufacture (name, manufacturer)生產(chǎn)信息 2.3.S.3 Characterisation (name, manufacturer) 特性 2.3.S.4 Control of Drug Substance (name, manufacturer)質(zhì)量控制 2.3.S.5 Reference Standards or Materials (name, manufacturer) 標準品或?qū)φ掌?br /> 2.3.S.6 Container Closure System (name, manufacturer) 包材信息 2.3.S.7 Stability (name, manufacturer) 穩(wěn)定性 MODULE 3 : QUALITY 模塊3：質(zhì)量 3.1.TABLE OF CONTENTS OF MODULE 3 模塊3目錄 3.2. BODY OF DATA主體數(shù)據(jù) 3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)原料藥（名稱，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) 結(jié)構(gòu) 3.2.S.1.3 General Properties (name, manufacturer) 一般性質(zhì) 3.2.S.2 Manufacture (name, manufacturer) 生產(chǎn) 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)制造工藝和工藝控制的敘述 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)關(guān)鍵步驟和中間體的控制 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)工藝驗證和/或評估 3.2.S.2.6 Manufacturing Process Development (name, manufacturer)制造工藝開發(fā) 3.2.S.3 Characterisation (name, manufacturer) 特性 3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer結(jié)構(gòu)和其它特性的闡明 3.2.S.3.2 Impurities (name, manufacturer) 雜質(zhì) 3.2.S.4 Control of Drug Substance (name, manufacturer) 原料藥的控制 3.2.S.4.1 Specification (name, manufacturer) 質(zhì)量標準 3.2.S.4.2 Analytical Procedures (name, manufacturer) 分析方法 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)分析方法的驗證 3.2.S.4.4 Batch Analyses (name, manufacturer)檢測報告 3.2.S.4.5 Justification of Specification (name, manufacturer) 質(zhì)量標準建立依據(jù) 3.2.S.5 Reference Standards or Materials (name, manufacturer)標準品或?qū)φ掌?br /> 3.2.S.6 Container Closure System (name, manufacturer) 包材 3.2.S.7 Stability (name, manufacturer) 穩(wěn)定性 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 穩(wěn)定性總結(jié) 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer)上市后的穩(wěn)定性方案和穩(wěn)定性承諾 3.2.S.7.3 Stability Data (name, manufacturer)穩(wěn)定性數(shù)據(jù) MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES模塊2：通用技術(shù)文件綜述 2.3 : QUALITY OVERALL SUMMARY (QOS)2.3：質(zhì)量綜述(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. 質(zhì)量綜述（QOS）由模塊3中主體數(shù)據(jù)的范圍和要點產(chǎn)生的概述。QOS不應(yīng)包含模塊3或CTD其它的部分中未包含的信息，數(shù)據(jù)或論證。 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應(yīng)包含每一部分的足夠信息以提供給質(zhì)量審核者模塊3綜述。QOS也應(yīng)強調(diào)產(chǎn)品的關(guān)鍵參數(shù)，如，提供論證指南未被遵循的情況。QOS應(yīng)包含對關(guān)鍵問題的討論，這些討論整合了來自質(zhì)量模塊章節(jié)的信息，及其它模塊的輔助信息。（如，在CTD-S模塊中討論的，經(jīng)由毒理研究雜質(zhì)的界定），包括相互參照其它模塊的容量和頁碼。 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通常不應(yīng)有超過40頁的正文（不包括表格和圖片）。對于生化產(chǎn)品和采用較復(fù)雜工藝制造的產(chǎn)品，文件的正文可以長點通常不應(yīng)超過80頁（不包括表格和圖片）。 The italicised text below indicates where tables, figures, or other items can be imported directly from Module 3表格，圖片或其他重要內(nèi)容下面的文字可以以斜體字體從模塊3中直接導(dǎo)入引用。 INTRODUCTION 介紹 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)原料藥 2.3.S.1 General Information (name, manufacturer) 一般信息 Information from 3.2.S.1 should be included. 應(yīng)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)包含原料藥的專用名稱，非專用名或通用名，公司名，劑型（多個），劑量（多個），給藥途徑，和擬定適應(yīng)癥（多個）。 2.3.S.2 Manufacture (name, manufacturer) 2.3.S.2 生產(chǎn)信息 Information from3.2.S.2 should be included: 應(yīng)包含3.2.S.2中的的信息 Information on the manufacturer生產(chǎn)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;制造過程（如，包括參考起始物料，關(guān)鍵步驟，和重處理）和旨在常規(guī)地，持續(xù)地生產(chǎn)出合格質(zhì)量的物料的控制的簡明敘述。A flow diagram, as provided in 3.2.S.2.2;如3.2.S.2.2提供的流程圖； 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中敘述原料藥制造工程中使用的起始原料和生物用品的來源。 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;關(guān)鍵生產(chǎn)步驟，工藝控制；關(guān)鍵中間體，控制標準的選擇和論證，包含在3.2.S.2.4中的敘述。 A description of process validation and/or evaluation, as described in 3.2.S.2.5. 描述在3.2.S.2.5.中敘述的工藝驗證和/或評估。 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中用于評估產(chǎn)品連貫性的評估結(jié)論的藥品開發(fā)過程，主要變更的概述。 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也應(yīng)交叉指出生產(chǎn)變更批次對非臨床的和臨床影響的研究，參考在申請文件中CTD-S和CTD-E模板。 2.3.S.3 Characterisation (name, manufacturer)特性 For NCE: 對新化學(xué)實體： 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中應(yīng)包括對結(jié)構(gòu)和異構(gòu)現(xiàn)象存在詮釋的概述。 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. 當(dāng)原料藥具有手性，應(yīng)詳細說明是否單一異構(gòu)體或消懸體在非臨床和臨床研究使用，將用處最后擬銷售制劑的原料藥的異構(gòu)體的信息應(yīng)給出。 For NCE and Biotech: 對新化學(xué)實體和生物技術(shù)產(chǎn)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應(yīng)概述在合成，制造和/或降解中產(chǎn)生的潛在的和實際存在的雜質(zhì)數(shù)據(jù)。應(yīng)概述設(shè)定單個和總和雜質(zhì)認可標準的基礎(chǔ)。QOS也應(yīng)概述用于非臨床研究，臨床實驗的原料藥批次中以及擬上市工藝制造的典型批次的雜質(zhì)水平。QOS應(yīng)注明擬定的雜質(zhì)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中提供的數(shù)據(jù)的表格概要，適當(dāng)?shù)膱D示。 2.3.S.4 Control of Drug Substance (name, manufacturer) 原料藥控制 A brief summary of the justification of the specification(s), the analytical procedures, and validation should be included. 包含對質(zhì)量標準，分析方法和驗證的簡明概述。 Specification from 3.2.S.4.1 should be provided.在 3.2.S.4.1提供的質(zhì)量標準應(yīng) 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中應(yīng)提供批次的分析數(shù)據(jù)的表格、圖。 2.3.S.5 Reference Standards or Materials (name, manufacturer) 2.3.S.5 標準品或?qū)φ掌? Information from 3.2.S.5 (tabulated presentation, where appropriate) should be included.3.2.S.5中包含的對照品或標準品的信息（適當(dāng)?shù)谋砀裥问浇o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. 應(yīng)包含3.2.S.6中信息的簡明說明和討論。 2.3.S.7 Stability (name, manufacturer) 2.3.S.7 穩(wěn)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. 這一部分應(yīng)包含所做的穩(wěn)定性概述（條件，批次，分析方法）和對結(jié)果和結(jié)論的簡明討論，擬定的儲存條件，復(fù)測期或貨架壽命，如3.2.S.7.1.敘述的相關(guān)內(nèi)容 The post-approval stability protocol, as described in 3.2.S.7.2, should be included. 應(yīng)包含3.2.S.7.2中敘述的，批準后的穩(wěn)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. 應(yīng)提供3.2.S.7.3中穩(wěn)定性結(jié)果的表格概述，適當(dāng)?shù)馗缴蠄D譜。 MODULE 3 : QUALITY 模塊3：質(zhì)量 SCOPE OF THE GUIDELINE 指南導(dǎo)讀 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. 本文件旨在對ICH指南Q6A（“新化合物實體”）和ICH指南Q6B（生物技術(shù)產(chǎn)品）范圍內(nèi)的原料藥和對應(yīng)的制劑的注冊申請的格式提供指南。此格式也可以適用于某些其它種類的產(chǎn)品。為確定此格式是否適用于特定類型的產(chǎn)品，申請者應(yīng)和相應(yīng)的管理部門咨詢。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. 各部分標題下的正文旨在用于解釋和說明。這些章節(jié)的內(nèi)容應(yīng)包含現(xiàn)ICH指南中敘述的相關(guān)信息，但對整個章節(jié)都獲得一致可行的內(nèi)容并不可行。本指南中的“主體數(shù)據(jù)”僅表明信息應(yīng)放在何處。具體的支持性數(shù)據(jù)的類型和程度都未發(fā)表在本指南中，但它們都應(yīng)根據(jù)各個區(qū)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部分的章節(jié)標題（地區(qū)的信息）代表了不通用于所有ICH區(qū)域典型話題信息的例子。因此，在這些章節(jié)中待提供的信息應(yīng)基于相關(guān)的地區(qū)性指南。 3.1. TABLE OF CONTENTS OF MODULE 3 3.1. 模塊3目錄 A Table of Contents for the filed application should be provided. 應(yīng)提供申請文件的目錄 3.2. BODY OF DATA 3.2. 主體數(shù)據(jù) 3.2.S DRUG SUBSTANCE1 (NAME, MANUFACTURER) 3.2.S 原料藥 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. 應(yīng)提供原料藥命名的信息，如建議的國際通用名（INN），相關(guān)的藥典名，化學(xué)名，公司或?qū)嶒炇掖a，其它的通用名，如本國名，美國采用的名稱，日本認可的名稱，英國批準的名稱，以及CAS登記號。 3.2.S.1.2 Structure (name, manufacturer) 3.2.S.1.2 結(jié)構(gòu) NCE: The structural formula, including relative and absolute stereochemistry, the molecular formula, and the relative molecular mass should be provided. 新化學(xué)實體應(yīng)提供包括相對的和絕對的立體化學(xué)的結(jié)構(gòu)式，分子式和相對的分子量。 3.2.S.1.3 General Properties (name, manufacturer)3.2.S.1.3 一般性質(zhì) A list should be provided of physicochemical and other relevant properties of the drug substance, including biological activity for Biotech. 應(yīng)提供原料藥的物理化學(xué)的或其它相關(guān)性質(zhì)的列表，包括生物技術(shù)產(chǎn)品的生物活性。 Reference ICH Guidelines: Q6A and Q6B 參考ICH指南：Q6A和 Q6B 。 3.2.S.2 Manufacture (name, manufacturer)3.2.S.2 生產(chǎn)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. 應(yīng)提供生產(chǎn)商的名稱，地址、職責(zé)。包括承包商，以及生產(chǎn)和檢測中涉及的每一個擬定的生產(chǎn)場地或設(shè)施。 3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 3.2.S.2.2 生產(chǎn)工藝和工藝控制的敘述 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. 原料藥生產(chǎn)工藝的敘述代表了申請者對原料藥制造的承諾。應(yīng)提供信息以準確地描述制造工藝和工藝控制。如：新分子實體應(yīng)提供合成工藝的一個（或多個）流程圖，包括分子式，重量，產(chǎn)率范圍。起始原料、中間體、試劑和原料藥的化學(xué)結(jié)構(gòu)和立體結(jié)構(gòu)，確定操作條件和溶劑。 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).應(yīng)遞交生產(chǎn)工藝的連續(xù)的程序性敘述。如，敘述應(yīng)包含可以反映商業(yè)生產(chǎn)的批次規(guī)模的原材料，溶劑，催化劑和反應(yīng)物的量，確定的關(guān)鍵步驟，工藝控制，設(shè)備和操作條件（如，溫度，壓力，pH,時間）。 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. 應(yīng)和主要工藝同等詳細程度地解釋和敘述可供替換的工藝；重處理步驟需要確定并合理。用于支持論證的數(shù)據(jù)可以在3.2.S.2.5.中闡述。 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列出原料藥生產(chǎn)中使用的物料（如，原料，起始物料，溶劑，反應(yīng)物，催化劑）的清單，標明每一原料使用在工藝中的哪里。應(yīng)提供這些物料的質(zhì)量和控制的信息。恰當(dāng)?shù)卣f明物料（包括生物來源的物料，如媒介組分，單克隆抗體，酶）滿足指定用途（包括外來試劑的清除或控制）的標準。對于生物來源的物料，包含關(guān)于來源，生產(chǎn)和特性的信息。詳見3.2.A.2）參考ICH指南：Q6A 和 Q6B 3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 3.2.S.2.4 關(guān)鍵步驟和中間體的控制 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. 關(guān)鍵步驟：應(yīng)提供在關(guān)鍵步驟（等同于3.2.S.2.2制造工藝）進行檢測和確定認可標準（包含實驗數(shù)據(jù)的論證）以確定工藝得到了控制。 Intermediates: Information on the quality and control of intermediates isolated during the process should be provided. Reference ICH Guidelines: Q6A and Q6B 參考ICH 指南：Q6A and Q6B 中間體：應(yīng)提供工藝中分離的中間體的質(zhì)量和控制的信息。 Additionally for Biotech: Stability data supporting storage conditions should be provided. 此外對生物技術(shù)產(chǎn)品：應(yīng)提供用于支持儲存條件的的穩(wěn)定性數(shù)據(jù)。 Reference ICH Guideline: Q5C 參考ICH指南：Q5C 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) 3.2.S.2.5 工藝驗證和/或評估 Process validation and/or evaluation studies for aseptic processing and sterilisation should be included. 應(yīng)包含無菌操作和滅菌的工藝驗證和/或評估 3.2.S.2.6 Manufacturing Process Development (name, manufacturer) 3.2.S.2.6 生產(chǎn)工藝的開發(fā) 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新化學(xué)實體：應(yīng)提供用于非臨床的，臨床的，放大規(guī)模的，中試的，可得的大生產(chǎn)批次的原料藥的制造工藝和/或制造地點顯著變更。 應(yīng)涉及3.2.S.4.4.中原料藥批次數(shù)據(jù)。參考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 結(jié)構(gòu)和其它性質(zhì)的闡明 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. 新化學(xué)實體：應(yīng)提供基于，如，合成路線和光譜分析的結(jié)構(gòu)確認。潛在異構(gòu)體，立體化學(xué)的識別，或潛在形成多晶型的信息。 Reference ICH Guideline: Q6A 參考ICH指南：Q6A 3.2.S.3.2 Impurities (name, manufacturer) 3.2.S.3.2 雜質(zhì) Information on impurities should be provided. Reference ICH Guidelines: Q3A, Q3C, Q5C, Q6A, and Q6B.應(yīng)提供雜質(zhì)的信息。參考ICH指南：Q3A, Q3C, Q5C, Q6A, and Q6B 3.2.S.4 Control of Drug Substance (name, manufacturer) 3.2.S.4 原料藥控制 3.2.S.4.1 Specification (name, manufacturer)3.2.S.4.1 質(zhì)量標準 The specification for the drug substance should be provided. Reference ICH Guidelines: Q6A and Q6B應(yīng)提供原料藥的質(zhì)量標準。參考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. 應(yīng)提供用于檢測原料藥的分析方法 Reference ICH Guidelines: Q2A and Q6B 參考ICH指南：Q2A 和 Q6B 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) 3.2.S.4.3 分析方法的驗證 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. 應(yīng)提供分析驗證信息，包括用于檢測原料藥的分析方法的實驗數(shù)據(jù)。參考ICH指南：Q2A, Q2B, and Q6B 3.2.S.4.4 Batch Analyses (name, manufacturer)3.2.S.4.4 分析報告 Description of batches and results of batch analyses should be provided. Reference ICH Guidelines: Q3A, Q3C, Q6A, and Q6B. 應(yīng)提供批次及批次分析的結(jié)果的敘述。參照ICH指南：Q3A, Q3C, Q6A, and Q6B。 3.2.S.4.5 Justification of Specification (name, manufacturer) 3.2.S.4.5 質(zhì)量標準制定依據(jù) Justification for the drug substance specification should be provided. Reference ICH Guidelines: Q3A, Q3C, Q6A and Q6B. 應(yīng)提供原料藥質(zhì)量標準的制定依據(jù)。參照ICH指南：Q3A, Q3C, Q6A and Q6B。 3.2.S.5 Reference Standards or Materials (name, manufacturer)3.2.S.5 標準品或?qū)φ掌?br /> Information on the reference standards or reference materials used for testing of the drug substance should be provided. Reference ICH Guidelines: Q6A and Q6B. 應(yīng)提供用于檢測原料藥的標準品或?qū)φ掌返男畔�。參照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. 應(yīng)提供包材的敘述，包括每一個主要包裝成分構(gòu)成材料以及它們的質(zhì)量標準。質(zhì)量標準應(yīng)包含敘述和鑒定（適當(dāng)?shù)臉嗣髦饕叽绲膱D片）。包括非藥典方法（需驗證）。 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. 對于非功能的第二層包裝成分（如，那些并不提供其他的保護），僅僅需提供簡明的敘述。對于實用的第二層包裝組分，應(yīng)提供進一步的信息。應(yīng)根據(jù)，如物料的選擇，濕度和光的防護，構(gòu)成的材料和原料藥的兼容性，包括對容器的吸收作用和瀝濾，和/或組成材料的安全性。 3.2.S.7 Stability (name, manufacturer) 3.2.S.7 穩(wěn)定性 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 3.2.S.7.1 穩(wěn)定性概述和結(jié)論 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. 應(yīng)概述所作研究的內(nèi)容、方案和研究的結(jié)果。如，概述應(yīng)包含強降解研究的結(jié)果和強降解條件。以及關(guān)于儲存條件和復(fù)測期或貨架壽命的結(jié)論。參照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 批準后的穩(wěn)定性方案和穩(wěn)定性承諾 The post-approval stability protocol and stability commitment should be provided. Reference ICH Guidelines: Q1A and Q5C. 應(yīng)提供批準后穩(wěn)定性方案和穩(wěn)定性承諾。參考ICH指南：Q1A and Q5C。 3.2.S.7.3 Stability Data (name, manufacturer) 3.2.S.7.3 穩(wěn)定性數(shù)據(jù) 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. 以恰當(dāng)?shù)母袷�，如表格，圖表，或陳述給出穩(wěn)定研究的結(jié)果（如，強降解研究和強降解條件）。用于產(chǎn)生數(shù)據(jù)的分析方法的信息以及這些方法的驗證應(yīng)包含在內(nèi)。參考ICH指南：Q1A, Q1B, Q2A, Q2B, 和 Q5C。 |
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