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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(méi)有區(qū)分性。
1.2 No reference is given to the current dossier.
1.2 沒(méi)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(píng)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(méi)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(méi)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(méi)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(shí)名稱(chēng)不一致
2.7 Descriptions of testing methods is repeated several times
2.7 檢測(cè)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(yǔ)表沒(méi)有在文件開(kāi)頭或結(jié)尾時(shí)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(duì)缺陷報(bào)告的回復(fù)沒(méi)有使用數(shù)字依次標(biāo)識(shí)。
3.2 Supplement is without synoptic index.
3.2 補(bǔ)充文件沒(méi)有概要索引。
P Drug product
制劑部分
P 1 Description and Composition of the Drug Product
Following information is often either missing or is incomplete:
下面信息缺失或者不完整
- Description of the dosage form
- 劑型描述
- Composition of the finished product
- 制劑組成
- Description of accompanying reconstitution diluent(s)
復(fù)溶劑的描述
- Type of container and closure used for the dosage form.
制劑包裝的類(lèi)型
P 2 Pharmaceutical Development
1. Pharmaceutical development reports are incomplete. Discussion on the following issues is missing:
藥物開(kāi)發(fā)報(bào)告不完整。下面討論缺失
- choice of composition and container
-組成選擇和包裝的選擇
- compatibility of the active substance(s) with excipients
-原輔料相容性
- key physicochemical characteristics of the active substance(s)
- 活性成分的關(guān)鍵理化性質(zhì)
- for combination products, compatibility of the active substances with each other
- 組合藥物的相容性
- choice of excipients, their concentration, their characteristics and influence on the performance
輔料選擇，輔料比例、特點(diǎn)和對(duì)性能的影響
- intended function of the excipients in the finished product
- 輔料在制劑中的目標(biāo)功能
- physicochemical and biological properties
(pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency,and/or immunological activity)
理化性質(zhì)和生物學(xué)性質(zhì)（pH、離子力、溶解度、重新分布、復(fù)溶、粒度分布、聚集、多晶型、流變學(xué)、生物學(xué)、免疫學(xué)性質(zhì)）
- suitability of the container closure system used for storage transportation (shipping)and use of the finished product.
- 用于存儲(chǔ)或運(yùn)輸制劑的包裝系統(tǒng)的適應(yīng)性
2. Results of at least two batches including graphical representations of the in-vitro-dissolution test.
至少兩批溶出曲線結(jié)果展示
3. Justification for the production/ stability overage.
過(guò)度投料或者穩(wěn)定性的理由
4. Justification for the addition of an antioxidant and/or an antimicrobial preservative.
增加抗氧化或抗微生物保護(hù)劑的理由
5. Formulation development
Information on the following issues is missing:
以下信息缺失
- Brief summary describing the development of the finished product
- 制劑成品開(kāi)發(fā)的總結(jié)
- Differences between clinical formulations and formulation (i.e. composition)
-臨床和商業(yè)化制劑組成的差異
- Results from comparative in vitro studies (e.g. dissolution) or comparative in vivo studies (e.g. bio equivalence).
- 體外溶出對(duì)比結(jié)果，或者體內(nèi)生物等效性對(duì)比結(jié)果
P 3 Manufacture
1. Batch Formula
1.1 Composition of the finished product per-unit basis (including overage, if any) is not submitted.
未遞交制劑成品每個(gè)單元的組成
1.2 The manufacturing formula is incomplete.
生產(chǎn)處方不完整
- Substance(s), that are used either in small amounts or are no more contained in thefinished product, are not included.
未包括用量極少或在成品中已不存在的物質(zhì)
- Specific amounts and/or range of amounts of the substance(s) used for pH-adjustment or to set osmolarity is not documented.
未包括用于調(diào)節(jié)pH或者滲透性的組成成分
- Manufacturing formula in the EU-format and/or in the dossier does not correspond to the composition.
歐盟格式和/或資料中的生產(chǎn)處方與成分不符
2. Description of Manufacturing Process and Process Controls
2.1 Flow diagram of the manufacturing process is not documented.
生產(chǎn)工藝的流程圖缺失
2.2 Method of preparation and filling of the finished product is described insufficiently is not included in the dossier.
資料中制劑的生產(chǎn)方式?jīng)]有完整的記錄
2.3 Controls of Critical Steps and Intermediates
- Tests and acceptance criteria performed at the critical steps of the manufacturing process, to ensure that the process is controlled, are often missing or incomplete.
為保證生產(chǎn)的可控性，關(guān)鍵步驟的檢測(cè)和接受標(biāo)準(zhǔn)缺失或者不完整
- Specifications and testing methods for in-process controls are often lacking.
中控的標(biāo)準(zhǔn)和檢測(cè)缺失
2.4 Process validation
- Information on relationship between product development, manufacturing process, product specifications and validation is missing.
產(chǎn)品開(kāi)發(fā)、生產(chǎn)工藝，產(chǎn)品質(zhì)量標(biāo)準(zhǔn)和驗(yàn)證的關(guān)系信息缺失
- Selection and optimisation of the manufacturing process, in particular its critical aspects, is not explained.
生產(chǎn)工藝的選擇和優(yōu)化，尤其是關(guān)鍵步驟的確定，沒(méi)有充分解釋
- Where validation data on production scale are not provided with the application,minimum information, in accordance with the validation scheme described in Annex I of Note for Guidance on Process Validation, is not submitted.
申請(qǐng)資料中沒(méi)有提供生產(chǎn)批量的驗(yàn)證數(shù)據(jù)，及必要與驗(yàn)證方案一致的信息
- Justification and dossier of validation for a procedure other than a standard procedure.
不同與標(biāo)準(zhǔn)方法的內(nèi)部方法，需要開(kāi)發(fā)理由與驗(yàn)證文件
P 4 Control of Excipients
1. Priority of the pharmacopoeias is not considered.
藥典的優(yōu)先度沒(méi)有被考慮
2. Specifications of excipients are not submitted.
輔料質(zhì)量標(biāo)準(zhǔn)沒(méi)有提交。
3. Information regarding origin (human or animal origin) information regarding sources,specifications; viral safety data is not provided.
沒(méi)有提交關(guān)于輔料的人源或動(dòng)物源的信息，質(zhì)量標(biāo)準(zhǔn)，病毒安全性數(shù)據(jù)
3. TSE-regulations, EU-directives /-decisions etc. are not considered for starting materials of animal origin.
動(dòng)物來(lái)源輔料的TSE信息沒(méi)有考慮。
4. Residual solvents are not indicated.
A validated testing method - including specification - is not submitted.
溶殘方法和質(zhì)量標(biāo)準(zhǔn)沒(méi)有遞交
P 5 Control of Drug Product
1. Specifications
1.1 Justification for the proposed drug product specification(s) is not provied.
沒(méi)有遞交制劑質(zhì)量標(biāo)準(zhǔn)的理由。
1.2 Release specifications and shelf-life specifications for the finished product are not submitted separately.
放行質(zhì)量標(biāo)準(zhǔn)和貨架期質(zhì)量標(biāo)準(zhǔn)沒(méi)有分開(kāi)遞交
1.3 Information on the general specifications of the finished product is incomplete. All necessary tests are not specified.
產(chǎn)品質(zhì)量標(biāo)準(zhǔn)信息不完整。所有必要的檢測(cè)沒(méi)有特定出來(lái)。
1.4 Identification of the decomposition products is missing.
缺少分解產(chǎn)物的鑒定。
1.5 Test results for the release specifications are not documented.
放行結(jié)果沒(méi)有記錄。
1.6 Ranges for the contents in the specification are set wide without justification.
較松的質(zhì)量接受限度沒(méi)有理由。
1.7 Inconsistent and contradictory specification of the content of the active substance and the decomposition products
主成分含量和雜質(zhì)限度接受限度設(shè)定不一致或存在矛盾。
2. Analytical procedures and their Validation
2.1 Submitted analytical procedure is not described in sufficient detail.
分析方法信息不夠詳細(xì)。
2.2 Information e.g. Accuracy, Precision (repeatability and intermediate precision), Specificity, Detection limit, Quantitation limit, Linearity, Range, Robustness) on the validation characteristics of their proposed analytical procedures is either not available or is incomplete.
分析方法驗(yàn)證的準(zhǔn)確度，精密度，特異性，檢測(cè)限，定量限，線性，范圍，耐用性等數(shù)據(jù)沒(méi)有提供或不完整。
2.4 Appropriate validation data to support the analytical procedures is not submitted.
分析方法的驗(yàn)證數(shù)據(jù)缺失。
2.5 Principle (theoretical basis) of rarely employed analytical procedures is neither explained nor described.
對(duì)于不常見(jiàn)的分析方法原理沒(méi)有解釋或描述。
2.6 Validation documents of the testing methods are either not available or are incomplete.
分析方法的驗(yàn)證文件缺失或不完整。
2.7 Different testing methods are often used alternatively without giving an explicit reference to the specification. Comparability of the results from the testing methods applied alternatively is not proven, e.g. through t-test, F-test.
不同的測(cè)試方法經(jīng)常交替使用，而沒(méi)有給出明確的質(zhì)量標(biāo)準(zhǔn)參考。未通過(guò)t檢驗(yàn)、f檢驗(yàn)等方法證明備選測(cè)試方法結(jié)果的可比性。
2.8 Product specific validation for pharmacopoeial testing method is not provided.
不提供藥典測(cè)試方法的產(chǎn)品特定驗(yàn)證。
2.9 Information and proof for validation of the testing methods for determination of content and for the purity tests carried out on the finished product are either missing or not sufficient.
用于含量測(cè)定和對(duì)成品進(jìn)行純度檢驗(yàn)的檢驗(yàn)方法驗(yàn)證的信息和證據(jù)要么缺失，要么不充分。
2.10 Statistical parameters are not indicated completely (e.g. only mean value and standard deviation).
統(tǒng)計(jì)參數(shù)沒(méi)有完全顯示（如：僅有均值和標(biāo)準(zhǔn)偏差）。
2.11 Illustrations of chromatograms for the detection limit are missing.
檢測(cè)限的色譜圖缺失。
3. Characterisation of Impurities
3.1 Purity tests on the finished product are not carried out at all or only very deficiently.
成品的純度檢驗(yàn)根本沒(méi)有進(jìn)行，或者進(jìn)行得很不充分。
3.2 Microbiological purity testing of topical and orally applicable drugs is either not performed according to Ph. Eur. or is missing entirely.
外用和口服藥物的微生物純度檢測(cè)要么沒(méi)有按照歐洲藥典進(jìn)行?；蛘咄耆槭?。
3.3 Endotoxin testing is not performed according to Ph. Eur.
沒(méi)有按歐洲藥典提供內(nèi)毒素的檢測(cè)。
4. Preservatives, antioxidants and other components which influence the bioavailability
For preservatives, antioxidants and other components identity tests and tests for the determination of the content and the range of tolerances are missing.
對(duì)于防腐劑、抗氧化劑和其他成分，缺少鑒別試驗(yàn)和測(cè)定含量和耐受范圍的試驗(yàn)。
5. Protocol for the release of the finished product
5.1 Information on the batch size and the date of the protocol, provided the protocol is available, is missing.
方案可用時(shí)，缺少批次大小和方案日期的信息。
5.2 Protocol for the release of the finished product, other testing methods are chosen than those described in the dossier.
成品放行方案中，選擇除檔案中描述的測(cè)試方法以外的其他測(cè)試方法。
5.3 Discrepancies occur between the specifications and quality characteristics actually tested.
質(zhì)量標(biāo)準(zhǔn)和實(shí)際測(cè)試的質(zhì)量特性之間存在差異。
5.4 Investigation results are submitted for the batches of other active substance concentrations or other container sizes than those applied for without any reasoning.
提交了其他活性物質(zhì)濃度批次或其他容器尺寸的研究結(jié)果，而沒(méi)有任何理由。
5.5 Scientific data concerning the analytical validation of methods and comments on the choice of routine tests and standards, is often missing or is incomplete.
缺失或者不完整提供關(guān)于方法分析驗(yàn)證的科學(xué)數(shù)據(jù)以及對(duì)常規(guī)測(cè)試和標(biāo)準(zhǔn)選擇理由。
P 6 Reference Standards or Materials
1. Reference standards are not specified.
對(duì)照品沒(méi)有特定化。
2. Content of reference standard is either missing or stated as only a range of the content.
對(duì)照品含量缺失或者僅限定一個(gè)范圍。
3. Reference is made to the quality of pharmacopoeial reagents, which is insufficient.
藥典試劑的質(zhì)量標(biāo)準(zhǔn)參考不充分。
P 7 Container Closure System
1. Description of the container closure system(s) is not provided.
包裝系統(tǒng)描述沒(méi)有提供。
2. Specifications are not submitted.
質(zhì)量標(biāo)準(zhǔn)沒(méi)有提供。
3. If the containers and closures are siliconised, the silicon oils are not specified and/or not sufficiently characterised.
如果容器和封蓋是硅油化的，硅油未被指定和/或未被充分表征。
4. Physical and chemical compatibility of the label adhesives and ink for the plastic containers is missing.
塑料容器的標(biāo)簽粘合劑和油墨的物理和化學(xué)相容性缺失。
5. Information on sterility is missing.
無(wú)菌信息缺失。
6. If sterile containers are used for the finished product, the information on their sterilisation is not documented.
如果成品使用無(wú)菌容器，滅菌信息沒(méi)有記錄。
P 8 Stability
P 8.1 Stability: Summary and Conclusion
Summary of stability studies including, for example, conclusions with respect to storage conditions and shelf-life, and, if applicable, in-use storage conditions and shelf-life, is not submitted.
未提交穩(wěn)定性研究的總結(jié)，包括，例如，關(guān)于儲(chǔ)存條件和保質(zhì)期的結(jié)論，以及，如果適用，使用中的儲(chǔ)存條件和保質(zhì)期。
P 8.2 Post-approval Stability Protocol and Stability Commitment
A commitment that the post-approval stability protocol and stability studies will besubmitted, is often missing.
批準(zhǔn)后的穩(wěn)定性方案和穩(wěn)定性研究將會(huì)提交的承諾缺失。
P 8.3 Stability Data
1. Stability studies
- Results of the stability studies are not presented in an appropriate format (e.g. tabular, graphical, narrative). Information on the analytical procedures used to generate the data and validation of these procedures is not included.
穩(wěn)定性研究的結(jié)果沒(méi)有以適當(dāng)?shù)母袷匠尸F(xiàn)(如表格、圖表、敘述)。用于生成數(shù)據(jù)的分析方法和這些方法的驗(yàn)證的信息沒(méi)有包括。
- In case, the mass balance between the formation of degradation products and the loss of the active substance is lacking, neither it is commented, nor additional tests are conducted.
-如果降解產(chǎn)物的形成和活性物質(zhì)的損失之間缺乏質(zhì)量平衡，沒(méi)有進(jìn)行評(píng)論，也不進(jìn)行額外的測(cè)試。
- To investigate the significance of obvious alterations in the characteristics of theproduct additional tests are not conducted. For example a distinct change in the colour of the product may necessitate additional investigation for degradation products.
-為了調(diào)查產(chǎn)品特性明顯變化的意義，沒(méi)有進(jìn)行額外的試驗(yàn)。例如，產(chǎn)品顏色的明顯變化可能需要對(duì)降解產(chǎn)物進(jìn)行額外調(diào)查。
- Stability studies under conditions of high humidity for products that are to be marketed in moisture-permeable containers, and especially for those which are potentially labile to moisture (e.g. antibiotics) are not included.
-沒(méi)有包括在高濕度條件下對(duì)將在透濕性容器中商業(yè)化產(chǎn)品的穩(wěn)定性研究，尤其是對(duì)水分潛在不穩(wěn)定的產(chǎn)品(如抗生素)。
2. Shelf-life specification
- Separate from the release specification, the proposed shelf-life specification with all stability relevant characteristics (especially microbiological purity, active substance content, decomposition products where appropriate and. in-vitro dissolution) is missing.
-與放行質(zhì)量標(biāo)準(zhǔn)分開(kāi)，缺失擬定的貨架壽命質(zhì)量標(biāo)準(zhǔn)，包括所有穩(wěn)定性相關(guān)特性(特別是微生物純度、活性物質(zhì)含量、分解產(chǎn)物(如適用)和體外溶出度)。
- Results of the stability examinations are not considered for the determination of the proposed shelf-life specifications.
穩(wěn)定性檢查的結(jié)果不被考慮用于確定擬定的保質(zhì)期質(zhì)量標(biāo)準(zhǔn)。
3. Changes in testing methods during the stability testing are made without proof of comparability of the results. Comparability of the results of the testing methods is not proven, e.g. through F-test, t-test.
穩(wěn)定性測(cè)試期間，在沒(méi)有證明結(jié)果可比性的情況下，對(duì)測(cè)試方法進(jìn)行了更改。測(cè)試方法結(jié)果的可比性未經(jīng)證明，例如通過(guò)f檢驗(yàn)、t檢驗(yàn)。
4. Following information for the conditions of the tested batches are often missing:
缺失下面測(cè)試批次的信息
- description of storage conditions
儲(chǔ)存條件描述
- used primary containers
使用的主要包裝
- composition and the size of batches
批次成分和批量。
- dates of manufacture.
生產(chǎn)日期
5. Proof of the specific determination of content of the active substance is missing.
缺少活性物質(zhì)含量具體測(cè)定的證明。
6. Content of preservatives and antioxidants is not determined.
保護(hù)劑和抗氧劑的含量沒(méi)有定量。
7. Impurities specified for release (only synthesis products, if they are decomposition products at the same time), are not checked during stability testing.
穩(wěn)定性試驗(yàn)期間，不檢查規(guī)定放行的雜質(zhì)(僅合成產(chǎn)物，如果它們同時(shí)是分解產(chǎn)物)。
8. For the stability, data following information is often missing:
穩(wěn)定性考察期間，缺失下面數(shù)據(jù)：
- Confirmation that the formulations used in the stability testing are identical to the formulation intended for the marketing and/or described somewhere in the dossier
-確認(rèn)穩(wěn)定性試驗(yàn)中使用的制劑與上市和/或資料中中描述的制劑相同
- Definition of the actual temperature at which the stability studies are conducted.
定義進(jìn)行穩(wěn)定性研究的實(shí)際溫度。
- Confirmation that containers used in the stability testing are the same as the proposed containers for the marketing and/or described somewhere in the dossier
-確認(rèn)穩(wěn)定性試驗(yàn)中使用的容器與上市用的和/或檔案中描述的容器相同
- Information on orientation of container and storage (e.g. Container stored upright, inverted, and its side)
-關(guān)于容器和儲(chǔ)存方向的信息(例如，容器直立、倒置和側(cè)面儲(chǔ)存)
- Test results of all quality characteristics for shelf-life specifications (e.g., in-vitro dissolution, preserving and decomposition products)
-貨架期質(zhì)量標(biāo)準(zhǔn)的所有質(zhì)量特性的測(cè)試結(jié)果(例如，體外溶解、保存和降解產(chǎn)物)
- Results of the tests at suitable intervals (often only initial and final values are submitted; interim results are missing or the initial values are missing)
適當(dāng)時(shí)間間隔的測(cè)試結(jié)果(通常只提交初始值和最終值；中間結(jié)果丟失或初始值丟失)
- Where appropriate, testing results (compatibility and stability with dilutions / mix-ings) of the reconstituted dosage form under defined conditions
-在適當(dāng)?shù)那闆r下，復(fù)溶劑型在規(guī)定條件下的測(cè)試結(jié)果(與稀釋液/混合液的相容性和穩(wěn)定性)
- Testing results for the suitability of the primary containers e.g. compatibility of the materials of construction with the dosage form (including sorption to container and leaching) safety of materials of construction, and performance (such as reproducibility of the dose delivery from the device when presented as part of the finished product)
主要容器適用性的測(cè)試結(jié)果，例如結(jié)構(gòu)材料與劑型的相容性(包括容器的吸附和浸出)、結(jié)構(gòu)材料的安全性和性能(例如作為成品的一部分時(shí)，從裝置中釋放的劑量的再現(xiàn)性)
- Clear and tabular representation of the results of all stability investigations, including their evaluation
-所有穩(wěn)定性調(diào)查(包括評(píng)估)結(jié)果的清晰列表
- Statement of concrete numerical values instead of verbal terms ("corresponds", "as above", "±", "ditto" and others).
-具體數(shù)值的陳述，而不是口頭術(shù)語(yǔ)(“對(duì)應(yīng)”、“如上”、“同上”等)。
9. In-use stability testing, where applicable
For multi-dose products either the in-use stability data on which the in-use shelf-life is based or a justification why no in-use shelf-life is established, are not submitted.
對(duì)于多劑量產(chǎn)品，沒(méi)有提交使用中的貨架期所依據(jù)的使用中的穩(wěn)定性數(shù)據(jù)或沒(méi)有確定使用中的保質(zhì)期的理由。
10. Reduced stability testing plan i.e. Bracketing and Matrixing Design for stability testing of drug substance, and drug product is applied without justification and/or without prior consultation with the concerned licensing authority.
在沒(méi)有正當(dāng)理由和/或沒(méi)有事先咨詢(xún)相關(guān)許可機(jī)構(gòu)的情況下減少穩(wěn)定性測(cè)試計(jì)劃，即原料藥和藥品穩(wěn)定性測(cè)試的分類(lèi)和矩陣設(shè)計(jì)。
11. Attempt to extrapolate data obtained in the trial beyond reasonable limits.
試圖將試驗(yàn)中獲得的數(shù)據(jù)外推至合理限度之外。
來(lái)源：文亮頻道
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