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A. General

1. Quality Overall Summary

質(zhì)量綜述

1.1 The quality overall summary is indiscriminate.

1.1 質(zhì)量總結(jié)沒有區(qū)分性。

1.2 No reference is given to the current dossier.

1.2 沒有引用M3資料。

1.3 The results, evaluation and cross-references to the pages of the dossier are missing.

1.3 缺失資料的結(jié)果、評估和交叉引用。

2. Chemical and Pharmaceutical Dossier

2.1 Dossier is not structured in accordance with the ICH-Guideline M4Q

2.1 資料沒有按照M4Q的要求結(jié)構(gòu)化

2.2 Table of contents is missing/incomplete.

2.2 缺失表格內(nèi)容

2.3 Sequence of documents cannot be assigned.

2.3 文件沒有序列化

2.4 Superfluous documents i.e. pharmacopeial monographs and complete law texts are submitted. Cross-references are missing.

2.4 藥典或者其他法規(guī)內(nèi)容沒有引用

2.5 Dossier is partially illegible.

- Bad copies for spectra and chromatograms are documented,

-圖譜復(fù)制文本質(zhì)量較差

- The Interpretations and legend of the submitted chromatograms are missing.

-缺失圖譜標(biāo)題或者注釋

2.6 Name of the preparation is not / rarely identical throughout the dossier.

2.6 上下文標(biāo)識名稱不一致

2.7 Descriptions of testing methods is repeated several times

2.7 檢測方法描述反復(fù)出現(xiàn)

2.8 Glossary is neither included in the beginning nor at the end of the dossier.

2.8 術(shù)語表沒有在文件開頭或結(jié)尾時出現(xiàn)

3. Answers to the Deficiency Reports / Supplements

3.1 Subsequent answers are not numbered in accordance with the deficiency report.

3.1 對缺陷報告的回復(fù)沒有使用數(shù)字依次標(biāo)識。

3.2 Supplement is without synoptic index.

3.2 補(bǔ)充文件沒有概要索引。

B. Quality (Core Dossier)

S Drug Substance

S 原料藥部分

S 1 General Information

1. Priority of the pharmacopoeias is not considered.

1. 沒有考慮藥典的優(yōu)先級

2. Information on the nomenclature is either not provided or is incomplete.

2. 命名信息不完整或沒有提供

S 2 Manufacture

1. Name and address of the responsible manufacturer, and proposed production site is not submitted

1.未提交生產(chǎn)商的名稱和地址，以及提議的生產(chǎn)地點

2. Information about the origin (human or animal origin)、 Information regarding adventitious agents (e.g., sources, specifications; viral safety data) is not submitted.

2.未提交關(guān)于來源的信息(人類或動物來源)、關(guān)于風(fēng)險物質(zhì)的信息(例如，來源、規(guī)格；病毒安全性數(shù)據(jù))。

3. Process validation and/or evaluation studies for aseptic processing and sterilisation are not submitted.

3. 沒有提交無菌加工和滅菌的工藝驗證和/或評估研究。

S 3 Characterisation

1. The physical constants such as solubility in water, buffers at different pH values and organic solvents are not described.

1.沒有描述物理性質(zhì)，例如在水中、不同pH值的緩沖液和有機(jī)溶劑中的溶解度。

2. Information i.e. potential for isomerism / forming polymorphs is not inclded. Existence/absence of polymorphism and chirality is not discussed.

2.不包括信息，即異構(gòu)化/形成多晶型的可能性。沒有討論多晶型和手性的存在/不存在。

3. Hygroscopicity, particle size distribution, flowability, granularity etc. not discussed in detail.

3.吸濕性、粒度分布、流動性、粒度等沒有詳細(xì)討論。

4. Chirality and polymorphism is not addressed adequately

4.手性和多晶型沒有詳細(xì)討論。

5. Impurities

5.1 Methods used to assess impurities are not qualified. Potential impurities are not discussed.

5.1用于評估雜質(zhì)的方法不合格。沒有討論潛在的雜質(zhì)。

5.2 Starting materials are not tested for unusual impurities

(e.g. amines, ethylene oxide, perchlorethylene, benzol, aluminium, residual solvents).

5.2不測試起始材料中的不常規(guī)雜質(zhì) (例如胺、環(huán)氧乙烷、全氯乙烯、苯、鋁、殘留溶劑)。

5.3 Starting materials, synthesised by using heavy metals as catalysts, are not tested for unusual impurities e. g. traces of palladium.

5.3 用重金屬作為催化劑合成的起始材料，不測試不常規(guī)雜質(zhì)，例如痕量鈀。

5.4 TSE-regulations, EU-directives /-decisions etc. are not considered for starting materials of animal origin.

5.4 針對來源于動物源的起始物料時，沒有考慮TSE-法規(guī)、EU-指令。

5.5 Residual solvents are not indicated. Validated testing method, including specification, is not submitted.

5.5未討論殘留溶劑。未提交經(jīng)過驗證的測試方法，包括質(zhì)量標(biāo)準(zhǔn)。

S 4 Control of Drug Substance

1. Specification for the drug substance is not submitted or lack attributes additional to compendia monograph, e.g. residual solvents, particle size distribution, chirality, polymorphism, crystal structure.

1.未提交原料藥的質(zhì)量標(biāo)準(zhǔn)，或缺少藥典專論之外的屬性，如殘留溶劑、粒度分布、手性、多晶型、晶體結(jié)構(gòu)。

2. Analytical procedures used for testing the drug substance are either not provided or are incomplete.

2.用于檢測原料藥的分析方法要么沒有提供，要么不完整。

3. Analytical validation information, including experimental data for the analytical procedures used for testing the drug substance are either not provided or are incomplete.

3.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)，要么沒有提供，要么不完整。

4. Certificate of analysis (COA) for secondary/working standards not provided.

4.未提供二級/工作標(biāo)準(zhǔn)品的分析證書(COA)。

5. Justification for the drug substance specification is not submitted.

5.沒有提交原料藥質(zhì)量標(biāo)準(zhǔn)的理由。

S 5 Reference Standard

1. Reference standards are not specified (purity testing).

1.對照品沒有指定(純度測試)。

2. Content of reference standard, used for assay, is either missing or is stated as only a range of the content.

2.用于含量測定的標(biāo)準(zhǔn)品的含量缺失，或僅說明為一個含量范圍。

3. Reference made to the quality of pharmacopeial reagents, is insufficient.

3.參考藥典試劑的質(zhì)量是不夠的。

S 6 Container Closure System

1. Description of the container closure system(s) is not provided.

1.沒有提供包裝容器封閉系統(tǒng)的描述。

2. Specifications are not submitted.

2.未提交質(zhì)量標(biāo)準(zhǔn)。

S 7 Stability of the Drug Substance(s)

1. The stability indicating method has not been used for stability studies.

1.穩(wěn)定性指示方法尚未用于穩(wěn)定性研究。

2. The forced degradation data is from literature. The results of the stability studies of the drug substance(s) (e.g., forced degradation studies and stress conditions) are not presented. Tabular, graphical, or narrative information is not included.

強(qiáng)制降解數(shù)據(jù)來自文獻(xiàn)。未列出原料藥穩(wěn)定性研究的結(jié)果(例如，強(qiáng)制降解研究和壓力條件)。不包括表格、圖形或敘述性信息。

3. Re-test period based on the results of long-term stability studies is not defined.

3.基于長期穩(wěn)定性研究結(jié)果的復(fù)驗期尚未確定。