【文章內容簡介】 .......................................... 20 REGIONAL INFORMATION.......................................................................................20 LITERATURE REFERENCES ......................................................................................211MODULE Module 2 : COMMON TECHNICAL DOCUMENT SUMMARIES模塊 2：通用技術文件概要 : QUALITY OVERALL SUMMARY (QOS): 質量概要（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.質量概要是對模塊 3 中的主要數(shù)據(jù)和范圍的小結。質量概要不能包括那些已經(jīng)不在模塊 3 或CTD 其它任何部分中的信息、數(shù)據(jù)或證明。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 (. qualification of impurities via toxicological studies discussed under the CTDS module), including crossreferencing to volume and page number in other Modules.質量概要應包括每部分的充足信息，給質量審核者提供模塊 3 的概況。質量概要還應重點強調產(chǎn)品的關鍵參數(shù)并提供，如，沒有按照指南進行時的說明。質量概要應包括對來自于質量模塊和其它模塊的支持信息（如，在 CTDS 模塊中通過毒理學研究對雜質定量等）關鍵問題的討論，包括交叉引用的其它模塊的卷號和頁碼。This QOS normally should not exceed 40 pages of text, excluding tables and figures. For biotech products and products manufactured using more plex processes, the document could be longer but normally should not exceed 80 pages of text (excluding tables and figures). 質量概要通常不超過 40 頁，除表格和數(shù)字外。對于生物制品和用更復雜的工藝生產(chǎn)的產(chǎn)品，文件可以長一些但通常不超過 80 頁（除表格和數(shù)據(jù)外）。The italicised text below indicates where tables, figures, or other items can be imported directly from Module 3.模塊 3 中說明表格、數(shù)字或其它項目的斜體文字可直接引用。 INTRODUCTION引言The introduction should include proprietary name, nonproprietary name or mon name of the drug substance, pany name, dosage form(s), strength(s), route of administration, and proposed indication(s).引言中應包括原料藥的專利商品名、非專利商品名，公司名稱、劑型、濃度、用藥途徑，說明。 DRUG SUBSTANCE (NAME, MANUFACTURER) 原料藥（名稱、廠商） General Information (name, manufacturer)（名稱，廠商）The Common Technical Document Quality2Information from should be included.應包括 中的信息。 Manufacture (name, manufacturer)（名稱，廠商）Information from should be included:應包括 中的信息：? Information on the manufacturer。? 廠商信息；? 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。? 簡述生產(chǎn)工藝（包括，如，起始原料、關鍵步驟和返工等）和可生產(chǎn)出具有優(yōu)良品質產(chǎn)品的生產(chǎn)控制。? A flow diagram, as provided in 。? 流程圖， 如 中所述 ；? 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 。? 簡要描述原料藥生產(chǎn)用的起始原料以及生物來源的原材料及其來源，如 中所述；? A discussion of the selection and justification of critical manufacturing steps, process controls, and acceptance criteria. Highlight critical process intermediates, as described in 。? 討論關鍵生產(chǎn)步驟、工藝控制和接受標準的選擇和論證，突出關鍵工藝中間體，如 中所述；? A description of process validation and/or evaluation, as described in .? 工藝驗證和/或評估的描述，如 中所述；? A brief summary of major manufacturing changes made throughout development and conclusions from the assessment used to evaluate product consistency, as described in . The QOS should also crossrefer to the nonclinical and clinical studies that used batches affected by these manufacturing changes, as provided in the CTDS and CTDE modules of the dossier.? 從對產(chǎn)品的評價到評估產(chǎn)品的一致性得到結論的過程中的重大生產(chǎn)變更的總結，如 中所述。質量概要還應參照使用受這些生產(chǎn)變更影響的批次進行的非臨床臨床研究，如文件CTDS 和 CTDE 模塊中所述； Characterisation (name, manufacturer)（名稱，廠商）For NCE:注意：A summary of the interpretation of evidence of structure and isomerism, as described in , should be included.The Common Technical Document – Quality3應包括結構和異構化的證據(jù)的簡要解說，如 所述。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. 當原料藥為手性藥時，應說明特定的立體異構體或立體異構體混合物是否已被用于非臨床和臨床研究，還應給出將用于市場的成品原料藥的立體異構體信息。For Biotech:生物制品：A description of the desired product and productrelated substances and a summary of general properties, characteristic features and characterisation data (for example, primary and higher order structure and biological activity), as described in , should be included.應包括對產(chǎn)品及產(chǎn)品有關物質的描述，及對一般性質、特征和特征數(shù)據(jù)（例如，初級和高級結構和生物活性）的小結，如 中所述。For NCE and Biotech:注意及生物制品：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 nonclinical studies, in the clinical trials, and in typical batches manufactured by the proposed mercial process. The QOS should state how the proposed impurity limits are qualified.質量概要應總結合成、生產(chǎn)和/或降解過程中產(chǎn)生的潛在的和實際的雜質，應說明設置的單個雜質和總雜質的接受標準的依據(jù)。質量概要還應概括用于非臨床研究、臨慶試驗和用既定的商業(yè)化工藝生產(chǎn)的典型批次的原料藥中的雜質水平。質量概要應敘述既定的雜質限度是如何達標的。A tabulated summary of the data provided in , with graphical representation, where appropriate should be included.應包括 中提供的數(shù)據(jù)一覽表，必要時用圖形表示。 Control of Drug Substance (name, manufacturer)（名稱，廠商）A brief summary of the justification of the specification(s), the analytical procedures, and validation sh