M4 Quality Step4 sept02 -中英对照
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
人用药物注册技术要求国际协调会议
ICH HARMONISED TRIPARTITE GUIDELINE
ICH
THE COMMON TECHNICAL DOCUMENT FOR THE
REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE:
QUALITY
QUALITY OVERALL SUMMARY OF MODULE 2
MODULE 3 : QUALITY
2
3
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 9 November 2000, this guideline is recommended for
adoption to the three regulatory parties to ICH
ICH指导委员会会议ICH进程第4步
2000年11月9日
该
指南
验证指南下载验证指南下载验证指南下载星度指南下载审查指南PDF
建议三方法规处采用ICH
(Numbering and Section Headers have been edited for consistency and use in e-CTD as
agreed at the Washington DC Meeting, September 11-12, 2002)
2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
该指南已经合格的专家工作组研究
并按照ICH程序经法规部协商。进程第4步最终草案已被欧盟、日本和美国采纳
THE COMMON TECHNICAL DOCUMENT FOR THE
REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE:
QUALITY
QUALITY OVERALL SUMMARY OF MODULE 2
MODULE 3 : QUALITY
2
3
ICH HARMONISED TRIPARTITE GUIDELINE
ICH
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 9 November 2000, this guideline is recommended for
adoption to the three regulatory parties to ICH
(Numbering and Section Headers have been edited for consistency and use in e-CTD as
agreed at the Washington DC Meeting, September 11-12, 2002)
ICH指导委员会会议ICH进程第4步
2000年11月9日
该指南建议三方法规处采用ICH
2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用
i
The Common Technical Document - Quality
TABLE OF CONTENTS
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES ............................... 6 2.3 : QUALITY OVERALL SUMMARY (QOS) .................................................................... 6 INTRODUCTION ..................................................................................................................... 6 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) ................................................... 6
2.3.S.1 General Information (name, manufacturer) ................................................... 6
2.3.S.2 Manufacture (name, manufacturer) ................................................................ 7
2.3.S.3 Characterisation (name, manufacturer) ......................................................... 7
2.3.S.4 Control of Drug Substance (name, manufacturer) ......................................... 8
2.3.S.5 Reference Standards or Materials (name, manufacturer) .............................. 8
2.3.S.6 Container Closure System (name, manufacturer) .......................................... 9
2.3.S.7 Stability (name, manufacturer) ....................................................................... 9 2.3.P DRUG PRODUCT (NAME, DOSAGE FORM) ........................................................... 9
2.3.P.1 Description and Composition of the Drug Product (name, dosage form) ....... 9
2.3.P.2 Pharmaceutical Development (name, dosage form) ....................................... 9
2.3.P.3 Manufacture (name, dosage form) .................................................................. 9
2.3.P.4 Control of Excipients (name, dosage form) ................................................... 10
2.3.P.5 Control of Drug Product (name, dosage form) .............................................. 10
2.3.P.6 Reference Standards or Materials (name, dosage form) ............................... 10
2.3.P.7 Container Closure System (name, dosage form) ........................................... 10
2.3.P.8 Stability (name, dosage form) ....................................................................... 10 2.3.A APPENDICES .............................................................................................................. 12
2.3.A.1 Facilities and Equipment (name, manufacturer) ......................................... 12
2.3.A.2 Adventitious Agents Safety Evaluation
(name, dosage form, manufacturer) .............................................................. 12
2.3.A.3 Excipients ....................................................................................................... 12 2.3.R REGIONAL INFORMATION .................................................................................... 12
MODULE 3 : QUALITY ................................................................................................ 13 3.1. TABLE OF CONTENTS OF MODULE 3 ...................................................................... 13 3.2. BODY OF DATA ............................................................................................................. 13 3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER) ................................................. 13
3.2.S.1 General Information (name, manufacturer) ................................................. 13
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The Common Technical Document – Quality
Nomenclature (name, manufacturer) ..................................................... 14 3.2.S.1.1
3.2.S.1.2 Structure (name, manufacturer) ............................................................. 15 3.2.S.1.3 General Properties (name, manufacturer).............................................. 15 3.2.S.2 Manufacture (name, manufacturer) .............................................................. 15 3.2.S.2.1 Manufacturer(s) (name, manufacturer) .................................................. 15 3.2.S.2.2 Description of Manufacturing Process and Process Controls (name,
manufacturer) .......................................................................................... 15 3.2.S.2.3 Control of Materials (name, manufacturer)............................................ 19 3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) .... 20 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) ................ 20 3.2.S.2.6 Manufacturing Process Development (name, manufacturer) ................ 21 3.2.S.3 Characterisation (name, manufacturer) ........................................................ 22 3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer)
................................................................................................................. 22 3.2.S.3.2 Impurities (name, manufacturer) ........................................................... 22 3.2.S.4 Control of Drug Substance (name, manufacturer) ........................................ 22 3.2.S.4.1 Specification (name, manufacturer) ........................................................ 23 3.2.S.4.2 Analytical Procedures (name, manufacturer) ......................................... 23 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) ................... 23 3.2.S.4.4 Batch Analyses (name, manufacturer) ................................................... 23 3.2.S.4.5 Justification of Specification (name, manufacturer) .............................. 23 3.2.S.5 Reference Standards or Materials (name, manufacturer) ............................ 23 3.2.S.6 Container Closure System (name, manufacturer) ........................................ 24 3.2.S.7 Stability (name, manufacturer) ..................................................................... 24 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer).................. 24 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name,
manufacturer) .......................................................................................... 24 3.2.S.7.3 Stability Data (name, manufacturer) ..................................................... 25
3.2.P DRUG PRODUCT (NAME, DOSAGE FORM) ........................................................ 25 3.2.P.1 Description and Composition of the Drug Product (name, dosage form)...... 25 3.2.P.2 Pharmaceutical Development (name, dosage form) ...................................... 27 3.2.P.2.1 Components of the Drug Product (name, dosage form) .......................... 27
3.2.P.2.1.1 Drug Substance (name, dosage form) ................................................. 27
3.2.P.2.1.2 Excipients (name, dosage form) ........................................................... 27 3.2.P.2.2 Drug Product (name, dosage form) ......................................................... 27
3.2.P.2.2.1 Formulation Development (name, dosage form) ................................. 28
3.2.P.2.2.2 Overages (name, dosage form) ............................................................ 28
iii
The Common Technical Document - Quality
Physicochemical and Biological Properties (name, dosage form) ....... 28 3.2.P.2.2.3
3.2.P.2.3 Manufacturing Process Development (name, dosage form)................... 28 3.2.P.2.4 Container Closure System (name, dosage form) .................................... 28 3.2.P.2.5 Microbiological Attributes (name, dosage form) .................................... 29 3.2.P.2.6 Compatibility (name, dosage form) ........................................................ 29 3.2.P.3 Manufacture (name, dosage form) ................................................................ 29 3.2.P.3.1 Manufacturer(s) (name, dosage form) .................................................... 29 3.2.P.3.2 Batch Formula (name, dosage form) ...................................................... 29 3.2.P.3.3 Description of Manufacturing Process and Process Controls (name,
dosage form) ............................................................................................ 30 3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form) ....... 30 3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form) .................. 31 3.2.P.4 Control of Excipients (name, dosage form) ................................................... 31 3.2.P.4.1 Specifications (name, dosage form) ........................................................ 31 3.2.P.4.2 Analytical Procedures (name, dosage form) ........................................... 31 3.2.P.4.3 Validation of Analytical Procedures (name, dosage form) ..................... 31 3.2.P.4.4 Justification of Specifications (name, dosage form) ............................... 32 3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form) ................ 32 3.2.P.4.6 Novel Excipients (name, dosage form) ................................................... 32 3.2.P.5 Control of Drug Product (name, dosage form) .............................................. 32 3.2.P.5.1 Specification(s) (name, dosage form) ...................................................... 32 3.2.P.5.2 Analytical Procedures (name, dosage form) ........................................... 32 3.2.P.5.3 Validation of Analytical Procedures (name, dosage form) ..................... 33 3.2.P.5.4 Batch Analyses (name, dosage form)...................................................... 33 3.2.P.5.5 Characterisation of Impurities (name, dosage form) ............................. 33 3.2.P.5.6 Justification of Specification(s) (name, dosage form) ............................. 33 3.2.P.6 Reference Standards or Materials (name, dosage form) ............................... 33 3.2.P.7 Container Closure System (name, dosage form) ........................................... 34 3.2.P.8 Stability (name, dosage form) ....................................................................... 34 3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)...................... 34 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name,
dosage form) ............................................................................................ 34 3.2.P.8.3 Stability Data (name, dosage form)........................................................ 35
3.2.A APPENDICES ............................................................................................................. 35 3.2.A.1 Facilities and Equipment (name, manufacturer) ......................................... 35 3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form,
manufacturer) ................................................................................................ 36
iv
The Common Technical Document – Quality
Excipients ....................................................................................................... 37 3.2.A.3
3.2.R REGIONAL INFORMATION ................................................................................... 37 3.3 LITERATURE REFERENCES .................................................................................. 38
v
The Common Technical Document – Quality
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES
2
: QUALITY OVERALL SUMMARY (QOS) 2.3
2.3: 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.
质量概要是对模块3中的主要数据和范围的小结。质量概要不能包括那些已经不在模块3或
CTD其它任何部分中的信息、数据或证明。
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 (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.
质量概要应包括每部分的充足信息，给质量审核者提供模块3的概况。质量概要还应重点强调产品的关键参数并提供，如，没有按照指南进行时的说明。质量概要应包括对来自于质量模块和其
它模块的支持信息（如，在CTD-S模块中通过毒理学研究对杂质定量等）关键问题的讨论，包
括交叉引用的其它模块的卷号和页码。
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).
质量概要通常不超过40页，除表格和数字外。对于生物制品和用更复杂的工艺生产的产品，文
件可以长一些但通常不超过80页（除表格和数据外）。 The italicised text below indicates where tables, figures, or other items can be imported
directly from Module 3.
模块3中说明表格、数字或其它项目的斜体文字可直接引用。 INTRODUCTION
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).
引言中应包括原料药的专利商品名、非专利商品名，公司名称、剂型、浓度、用药途径，说明。
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)
2.3.s
2.3.S.1 General Information (name, manufacturer)
2.3.S.1
Information from 3.2.S.1 should be included.
6
The Common Technical Document - Quality
应包括3.2.S.1中的信息。
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.2 Information from 3.2.S.2 should be included:
应包括3.2.S.2中的信息：
, Information on the manufacturer;
, 厂商信息；
, 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;
, 简述生产工艺（包括，如，起始原料、关键步骤和返工等）和可生产出具有优良品质产品的
生产控制。
, A flow diagram, as provided in 3.2.S.2.2;
流程图，如3.2.S.2.2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 3.2.S.2.3;
, 简要描述原料药生产用的起始原料以及生物来源的原材料及其来源，如3.2.S.2.3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 3.2.S.2.4;
, 讨论关键生产步骤、工艺控制和接受
标准
excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载
的选择和论证，突出关键工艺中间体，如3.2.S.2.4
中所述；
, A description of process validation and/or evaluation, as described in 3.2.S.2.5.
, 工艺验证和/或评估的描述，如3.2.S.2.5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
3.2.S.2.6. 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.
, 从对产品的评价到评估产品的一致性得到结论的过程中的重大生产变更的总结，如3.2.S.2.6
中所述。质量概要还应参照使用受这些生产变更影响的批次进行的非临床临床研究，如文件
CTD-S和CTD-E模块中所述； 2.3.S.3 Characterisation (name, manufacturer)
2.3.S.3 For NCE:
注意：
A summary of the interpretation of evidence of structure and isomerism, as described
in 3.2.S.3.1, should be included.
应包括结构和异构化的证据的简要解说，如3.2.S.3.1所述。
7
The Common Technical Document - Quality
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.
当原料药为手性药时，应说明特定的立体异构体或立体异构体混合物是否已被用于非临床和
临床研究，还应给出将用于市场的成品原料药的立体异构体信息。
For Biotech:
生物制品：
A description of the desired product and product-related 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 3.2.S.3.1,
should be included.
应包括对产品及产品有关物质的描述，及对一般性质、特征和特征数据（例如，初级和高级
结构和生物活性）的小结，如3.2.S.1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 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.
质量概要应总结合成、生产和/或降解过程中产生的潜在的和实际的杂质，应说明设置的单个
杂质和总杂质的接受标准的依据。质量概要还应概括用于非临床研究、临庆试验和用既定的
商业化工艺生产的典型批次的原料药中的杂质水平。质量概要应叙述既定的杂质限度是如何
达标的。
A tabulated summary of the data provided in 3.2.S.3.2, with graphical representation, where
appropriate should be included.
应包括3.2.S.3.2中提供的数据一览表，必要时用图形表示。
2.3.S.4 Control of Drug Substance (name, manufacturer)
2.3.S.4 A brief summary of the justification of the specification(s), the analytical procedures, and
validation should be included.
应包括对质量标准、分析程序和验证的说明的简单小结。
Specification from 3.2.S.4.1 should be provided.
应提供3.2.S.4.1中的质量标准。 A tabulated summary of the batch analyses from 3.2.S.4.4, with graphical representation
where appropriate, should be provided.
应提供3.2.S.4.4中的批分析小结表，必要时应用图形表示。
2.3.S.5 Reference Standards or Materials (name, manufacturer)
8
The Common Technical Document - Quality 2.3.S.5 Information from 3.2.S.5 (tabulated presentation, where appropriate) should be included.
应包括3.2.S.5中的信息（必要时用表格表示）。 2.3.S.6 Container Closure System (name, manufacturer)
2.3.S.6 A brief description and discussion of the information, from 3.2.S.6 should be included.
应包括对3.2.S.6的信息的简要描述和讨论。 2.3.S.7 Stability (name, manufacturer)
2.3.S.7
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.
该项应包括对已进行的研究的小结（条件、批次和分析方法）及对结果、结论、预定的贮存条
件、复验日期或有效期等相关信息的简单讨论，如3.2.S.7.1中所述。
The post-approval stability protocol, as described in 3.2.S.7.2, should be included.
应包括批准后的稳定性
方案
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，如3.2.S.7.1中所述。 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中的稳定性结果的数据表，必要时应用图形表示。
2.3.P DRUG PRODUCT (NAME, DOSAGE FORM)
2.3.P
2.3.P.1 Description and Composition of the Drug Product (name, dosage form)
2.3.P.1 Information from 3.2.P.1 should be provided.
应提供3.2.P.1中的信息。
Composition from 3.2.P.1 should be provided.
应提供3.2.P.1中的组份。
2.3.P.2 Pharmaceutical Development (name, dosage form)
2.3.P.2
A discussion of the information and data from 3.2.P.2 should be presented.
应有对3.2.P.2中的信息和数据的讨论。 A tabulated summary of the composition of the formulations used in clinical trials and a
presentation of dissolution profiles should be provided, where relevant. 应提供用于临床试验的处方组成的表格总结。 2.3.P.3 Manufacture (name, dosage form)
9
The Common Technical Document - Quality
2.3.P.3
Information from 3.2.P.3 should include:
应包括3.2.P.3中的信息：
, Information on the manufacturer.
, 厂商信息。
, A brief description of the manufacturing process and the controls that are intended to
result in the routine and consistent production of product of appropriate quality.
, 简述生产工艺和对优良品质产品的常规稳定生产的控制。
, A flow diagram, as provided under 3.2.P.3.3.
流程图，如3.2.P.3.3 ,
, A brief description of the process validation and/or evaluation, as described in 3.2.P.3.5.
, 简述工艺验证和/或评估，如3.2.P.3.5中所述。 2.3.P.4 Control of Excipients (name, dosage form)
2.3.P.4
A brief summary on the quality of excipients, as described in 3.2.P.4, should be included.
应包括辅料质量的简单小结，如在3.2.P.4中所述。 2.3.P.5 Control of Drug Product (name, dosage form)
2.3.P.5
A brief summary of the justification of the specification(s), a summary of the analytical
procedures and validation, and characterisation of impurities should be provided.
应提供对质量标准说明、分析方法和验证的小结以及杂质特征的简单总结。
Specification(s) from 3.2.P.5.1 should be provided.
应提供3.2.P.5.1中的质量标准。
A tabulated summary of the batch analyses provided under 3.2.P.5.4, with graphical
representation where appropriate should be included.
应包括3.2.P.5.4项下批分析小结，适当时采用图形表示。 2.3.P.6 Reference Standards or Materials (name, dosage form)
2.3.P.6 Information from 3.2.P.6 (tabulated presentation, where appropriate) should be included.
应包括3.2.P.6中信息（适当时采用表格形式）。
2.3.P.7 Container Closure System (name, dosage form)
2.3.P.1 A brief description and discussion of the information in 3.2.P.7 should be included.
应包括对3.2.P.7中信息的简述和讨论。 2.3.P.8 Stability (name, dosage form)
10
The Common Technical Document - Quality 2.3.P.8
A summary of the studies undertaken (conditions, batches, analytical procedures) and a
brief discussion of the results and conclusions of the stability studies and analysis of data
should be included. Conclusions with respect to storage conditions and shelf-life and, if
applicable, in-use storage conditions and shelf-life should be given.
应给出已进行的研究（条伯、批次和分析方法）的小结，以及对稳定性研究、数据分析的结果和
结论的简单讨论。如适用，应给出结论相关的贮存条件和效期。 A tabulated summary of the stability results from 3.2.P.8.3, with graphical representation
where appropriate, should be included.
应包括3.2.P.8.3中稳定性结果的表格总结，适当时采用图形表示。 The post-approval stability protocol, as described in 3.2.P.8.2, should be provided.
应提供3.2.P.8.2中所述的经批准后的稳定性方案。
11
The Common Technical Document - Quality
2.3.A APPENDICES
2.3.A
2.3.A.1 Facilities and Equipment (name, manufacturer)
2.3.A.1 Biotech:
生物制品
A summary of facility information described under 3.2.A.1 should be included.
应包括3.2.A.1项下所述的设施信息总结。 2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form,
manufacturer)
2.3.A.2 A discussion on measures implemented to control endogenous and adventitious agents in
production should be included.
应包括对控制生产中内源性和外源性试剂所采取措施的讨论。
A tabulated summary of the reduction factors for viral clearance from 3.2.A.2, should be
provided.
应提供3.2.A.2项下病毒清除的还原因子的总结。 2.3.A.3 Excipients
2.3.A.3
2.3.R REGIONAL INFORMATION
2.3.R
A brief description of the information specific for the region, as provided under “3.2.R”
should be included, where appropriate.
适当时应包括3.2.R项下所述的区域特定信息的简单描述。
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MODULE 3 : QUALITY
3
SCOPE OF THE GUIDELINE
指南的范围
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.
本文旨在提供ICH指南Q6A（NCE）和ICH指南Q6B（Biotech）中定义的原料药及其制剂注册申请格式指南。为了确定该格式对于特定类型产品的适用性，申请者应咨询适当的法规机构。
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.
章节标题后的文本仅用于解释和说明。这些章节的内容应包括现行ICH指南中描述的相关信
息，但协调的内容不适用于所有章节。该指南中“数据正文”仅指出这些信息应该位于什么地
方。该指南既没有确定特定支撑数据的类型也没有确定其范围，这两项的内容均可依据区域指
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.
章节标题3.2.R部分（区域信息）代表了不通用于所有ICH区域的信息的典型实例。因此，在这些章节要提供的信息应依据相关区域指南。
3.1. TABLE OF CONTENTS OF MODULE 3
3.1. 3
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.
13.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)
3.2.S
3.2.S.1 General Information (name, manufacturer)
1For a drug product containing more than one drug substance, the information requested for part
“S” should be provided in its entirety for each drug substance
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3.2.S.1 3.2.S.1.1 Nomenclature (name, manufacturer)
3.2.S.1.1 Information on the nomenclature of the drug substance should be provided. For example:
应提供原料药的命名信息。例如： , Recommended International Nonproprietary Name (INN);
, 推荐的国际非专利名称； , Compendial name if relevant;
, 相关药典中的名称；
, Chemical name(s);
, 化学名称；
, Company or laboratory code;
, 公司或实验室编码；
, Other non-proprietary name(s), e.g., national name, United States Adopted Name
(USAN), Japanese Accepted Name (JAN); British Approved Name (BAN), and
, 其它非专利名称，如，国家名称，美国采用名称，日本接受名称；英国批准名称，和
, Chemical Abstracts Service (CAS) registry number.
, 化学文摘注册号。
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3.2.S.1.2 Structure (name, manufacturer)
3.2.S.1.2 NCE:
NCE
The structural formula, including relative and absolute stereochemistry, the molecular
formula, and the relative molecular mass should be provided.
应提供结构式，包括相对的和绝对的立体化学结构式、分子式以及相对分子量。
Biotech:
The schematic amino acid sequence indicating glycosylation sites or other post-
translational modifications and relative molecular mass should be provided, as
appropriate.
适当时应提供氨基酸序列图，指出糖基化位置或其它翻译后的修钸和相对分子量。
3.2.S.1.3 General Properties (name, manufacturer)
3.2.S.1.3 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或其它相关性质，包括生物制品的生物活性。
Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
3.2.S.2 Manufacture (name, manufacturer)
3.2.S.2 3.2.S.2.1 Manufacturer(s) (name, manufacturer)
3.2.S.2.1 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.
应提供每个厂商的名称、地址和职责，包括签约人、涉及生产和检验的每个预定的生产厂址或厂
房。
3.2.S.2.2 Description of Manufacturing Process and Process Controls (name,
manufacturer)
3.2.S.2.2
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:
表明申请者承诺生产原料药的生产工艺的描述。提供的信息应能够充分描述生产工艺和工艺控
制。例如：
NCE:
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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.
应提供合成工艺的流程图，包括分子式、重量、产量范围，起始原料、中间体、试剂和反映
立体化学的原料药的化学结构式，指出操作条件和溶剂。
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).
应提交生产工艺工序的叙述。叙述应包括，如，原材料、溶剂、催化剂和能反映商业生产代
表批量的试剂用量，关键步骤、工艺控制、设备和操作条件（如温度、压力、pH、时间等）
的确定。
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.
对更换工艺的描述应像最初工艺一样有详细的解释和说明。应确定并说明返工步骤。应参考
采用3.2.S.2.5中能够支撑这些说明的任何数据。
Biotech:
Information should be provided on the manufacturing process, which typically starts
with a vial(s) of the cell bank, and includes cell culture, harvest(s), purification and
modification reactions, filling, storage and shipping conditions.
应提供生产工艺信息，可从细胞库开始，包括细胞培养、放罐、纯化和修饰、填充、贮存和
装运条件。
Batch(es) and scale definition
批和批量定义 An explanation of the batch numbering system, including information regarding any
pooling of harvests or intermediates and batch size or scale should be provided.
应提供对批编号系统的说明，包括关于放罐、中间体和批量的住信息。
Cell culture and harvest
细胞培养和放罐 A flow diagram should be provided that illustrates the manufacturing route from the
original inoculum (e.g. cells contained in one or more vials(s) of the Working Cell Bank
up to the last harvesting operation. The diagram should include all steps (i.e., unit
operations) and intermediates. Relevant information for each stage, such as population
doubling levels, cell concentration, volumes, pH, cultivation times, holding times, and
temperature, should be included. Critical steps and critical intermediates for which
specifications are established (as mentioned in 3.2.S.2.4) should be identified.
应提供流程图，描绘从原始菌种（如装在一支或多支安瓿中的工作细胞库）到最后成熟放罐
操作。流程图应包括所有步骤（如单元操作）和中间体。应包括每一阶段的相关信息，如复
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The Common Technical Document - Quality 壮、细胞浓度、体积、pH、培养时间、放置时间和温度。应确定关键步骤及建立质量标准的
关键中间体（如中3.2.S.2.4所述）。
A description of each process step in the flow diagram should be provided. Information
should be included on, for example, scale; culture media and other additives (details
provided in 3.2.S.2.3); major equipment (details provided in 3.2.A.1); and process
controls, including in-process tests and operational parameters, process steps,
equipment and intermediates with acceptance criteria (details provided in 3.2.S.2.4).
Information on procedures used to transfer material between steps, equipment, areas,
and buildings, as appropriate, and shipping and storage conditions should be provided.
(Details on shipping and storage provided in 3.2.S.2.4.)
应提供流程图中每一工艺步骤的描述。应包括的信息，如，规模、培养基和其它添加剂（在
3.2.S.2.3中详细提供）；主要设备（在3.2.A.1中详细提供）；和工艺控制，包括工艺检查和操作参数、工艺步骤、设备和具有接受标准的中间体（在3.2.S.2.4中详细提供）。还应
提供各步骤之间、设备、区域和建筑物之间物料传送程序的信息。（在3.2.S.2.4装运和贮
存中详细提供）。
Purification and modification reactions
纯化和修饰反应
A flow diagram should be provided that illustrates the purification steps (i.e., unit
operations) from the crude harvest(s) up to the step preceding filling of the drug
substance. All steps and intermediates and relevant information for each stage (e.g.,
volumes, pH, critical processing time, holding times, temperatures and elution profiles
and selection of fraction, storage of intermediate, if applicable) should be included.
Critical steps for which specifications are established as mentioned in 3.2.S.2.4 should
be identified.
应提供流程图，描绘从原始发酵液到原料药灌装前的纯化步骤（如，单元操作）。应包括所
有步骤、中间体以及每一阶段的相关信息（如体积、pH、关键工艺时间、放置时间、温度和洗脱及部分选取、中间体贮存，如适用）。应确定如3.2.S.2.4中所述质量标准的关键步
骤。
A description of each process step (as identified in the flow diagram) should be provided.
The description should include information on, for example, scale, buffers and other
reagents (details provided in 3.2.S.2.3, major equipment (details provided in 3.2.A.1),
and materials. For materials such as membranes and chromatography resins,
information for conditions of use and reuse also should be provided. (Equipment details
in 3.2.A.1; validation studies for the reuse and regeneration of columns and
membranes in 3.2.S.2.5.) The description should include process controls (including in-
process tests and operational parameters) with acceptance criteria for process steps,
equipment and intermediates. (Details in 3.2.S.2.4.)
应提供每一工艺步骤（如流程中确定）的描述。应包括，如，比例、缓冲试剂和其它试剂
（详情见3.2.S.2.3）、关键设备（详情见3.2.A.1）和物料。对于薄膜和色谱树脂等物料，使用和重复使用的条件也应提供。（设备详情见3.2.A.1，柱子和薄膜重复使用和再生的验证研究见3.2.S.2.5）。还应包括具有接受标准的工艺步骤、设备和中间体的工艺控制（包
括工艺检查和操作参数）描述。
Reprocessing procedures with criteria for reprocessing of any intermediate or the drug
substance should be described. (Details should be given in3.2.S.2.5 .)
应描述任何中间体或原料药返工的程序。（应在3.2.S.2.5中详细描述）
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Information on procedures used to transfer material between steps, equipment, areas,
and buildings, as appropriate, and shipping and storage conditions should be provided
(details on shipping and storage provided in 3.2.S.2.4.).
适当时应提供物料在各步骤、设备、区域和建筑物之间转移的程序以及装运和贮存条件（装
运和贮存条件在3.2.S.2.4中详细描述）。 Filling, storage and transportation (shipping) 填充、贮存和运输（装运）
A description of the filling procedure for the drug substance, process controls (including
in-process tests and operational parameters), and acceptance criteria should be
provided. (Details in 3.2.S.2.4.) The container closure system(s) used for storage of the
drug substance (details in 3.2.S.6.) and storage and shipping conditions for the drug
substance should be described.
应提供原料药、工艺控制（包括工艺检查和操作参数）和接受标准。（详情见3.2.S.2.4.）
应描述用于原料药（详情见3.2.S.6）贮存的容器密封系统和贮存、装运条件。
Reference ICH Guidelines: Q5A, Q5B, and Q6B
参照ICH指南：Q5A、Q5B和Q6B
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The Common Technical Document - Quality 3.2.S.2.3 Control of Materials (name, manufacturer)
3.2.S.2.3
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)
应列出原料药生产用物料（如，原材料、起始物料、溶剂、试剂和催化剂）并说明在工艺中哪一
步使用了这些物料。应提供这些物料质量及控制的信息。适当时应提供证明这些物料（包括生物
来源的物料，如，培养基组份、单克隆抗体、酶）符合使用（包括外源性试剂的控制及清除）标
准的信息。对于生物来源的物料，可包括关于来源、生产和特征的信息。（详情见3.2.A.2 中
NCE 和 Biotech）。
Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
Biotech:
Control of Source and Starting Materials of Biological Origin
生物来源起始物料及来源控制
Summaries of viral safety information for biologically-sourced materials should be
provided. (Details in 3.2.A.2.)
应提供生物来源物料病毒安全信息的小结。（详情见3.2.A.2）
Source, history, and generation of the cell substrate
细胞的来源、历史和传代
Information on the source of the cell substrate and analysis of the expression construct
used to genetically modify cells and incorporated in the initial cell clone used to develop
the Master Cell Bank should be provided as described in Q5B and Q5D.
应提供细胞来源、用于基因修饰的细胞的结构表达分析和用于研究主细胞库的原始细胞克隆
信息，如Q5B和Q5D中所述。
Cell banking system, characterisation, and testing
细胞库系统，特征和检测
Information on the cell banking system, quality control activities, and cell line stability
during production and storage (including procedures used to generate the Master and
Working Cell Bank(s)) should be provided as described in Q5B and Q5D.
应提供细胞库系统、质量控制活动和生产与贮存过程中（包括用于生产主细胞库和工作细胞
库的程序）细胞的稳定性信息，如Q5B和Q5D中所述。 Reference ICH Guidelines: Q5A, Q5B, Q5C and Q5D
参照ICH指南：Q5A、Q5B、Q5C和Q5D。
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3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.4
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3.2.S.2.2中确定的生产工艺的关键步骤中进行的检测和接受标准（包括对实验数据的说明）以保证工艺是受控的。 Intermediates: Information on the quality and control of intermediates isolated during the
process should be provided.
中间体：应提供在生产工艺中分离的中间体的质量和管理信息。
Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
Additionally for Biotech: Stability data supporting storage conditions should be provided.
生物制品应增加：应提供支撑贮存条件的稳定性数据。
Reference ICH Guideline: Q5C
参照ICH指南：Q5C
3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)
3.2.s.2.5 / Process validation and/or evaluation studies for aseptic processing and sterilisation should
be included.
应包括无菌工艺或灭菌的工艺验证和/或评估研究。 Biotech:
Sufficient information should be provided on validation and evaluation studies to
demonstrate that the manufacturing process (including reprocessing steps) is suitable
for its intended purpose and to substantiate selection of critical process controls
(operational parameters and in-process tests) and their limits for critical
manufacturing steps (e.g., cell culture, harvesting, purification, and modification).
应提供验证和评估研究的充分信息以证明生产工艺（包括返工步骤）适于其预其目的并证明
关键工艺控制（操作参数和工艺检验）及关键生产步骤的限度（如细胞培养物、放罐、纯化
和修饰）。
The plan for conducting the study should be described and the results, analysis and
conclusions from the executed study(ies) should be provided. The analytical procedures
and corresponding validation should be cross-referenced (e.g., 3.2.S.2.4, 3.2.S.4.3) or
provided as part of justifying the selection of critical process controls and acceptance
criteria.
应描述进行研究的计划并提供已进行的研究的结果、分析及结论。应引用分析规程和相应的
验证或将其对选择关键控制和接受标准的说明一部分。
For manufacturing steps intended to remove or inactivate viral contaminants, the
information from evaluation studies should be provided in 3.2.A.2.
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应提供3.2.A.2中所述的用于去除或灭活病菌毒感染物的生产步骤，以及评估研究的信息。
3.2.S.2.6 Manufacturing Process Development (name, manufacturer)
3.2.S.2.6
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.
应提供用于生产非临床、临床、中试、小试和生产批量的原料药的生产工艺和/或生产地址的
重大变更的描述和讨论。
Reference should be made to the drug substance data provided in section 3.2.S.4.4.
应参照3.2.S.4.4节中提供的原料药数据。
Reference ICH Guideline: Q3A
参照ICH指南：Q3A
Biotech:
The developmental history of the manufacturing process, as described in 3.2.S.2.2,
should be provided. The description of change(s) made to the manufacture of drug
substance batches used in support of the marketing application (e.g., nonclinical or
clinical studies) should include, for example, changes to the process or to critical
equipment. The reason for the change should be explained. Relevant information on
drug substance batches manufactured during development, such as the batch number,
manufacturing scale, and use (e.g., stability, nonclinical, reference material) in relation
to the change, should be provided.
应提供如3.2.S.2.2中所述的生产工艺研究历史。应包括用于支持上市申请（如非临床或临
床研究）的原料药批次的生产的变更描述，例如，工艺或关键设备的变更。应解释变更原
因。应提供研究过程中原料药生产批次的相关信息，如批号、生产规模和用途（如稳定性、
非临床和参照物质）相关的变更。 The significance of the change should be assessed by evaluating its potential to impact
the quality of the drug substance (and/or intermediate, if appropriate). For
manufacturing changes that are considered significant, data from comparative
analytical testing on relevant drug substance batches should be provided to determine
the impact on quality of the drug substance (see Q6B for additional guidance). A
discussion of the data, including a justification for selection of the tests and assessment
of results, should be included.
通过评估变更对原料药（和/或中间体，如适用）质量的潜在影响以评价变更的重要性。对于确定为重大变更的生产变更，应提供相关原料药批次的对照分析数据以确定对原料药质量的
影响（见Q6B附加指南）。应包括对数据的讨论，其中应包含对选择检验和结果评估的说
明。
Testing used to assess the impact of manufacturing changes on the drug substance(s)
and the corresponding drug product(s) can also include nonclinical and clinical studies.
Cross-reference to the location of these studies in other modules of the submission
should be included.
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用于评价生产变更对原料药及相应成品的影响的检测也可包括非临庆和临床研究。应包括交
叉引用提交和其它模块中的这些信息。
Reference should be made to the drug substance data provided in section 3.2.S.4.4.
应参照在3.2.S.4.4中提供的原料药数据。
Reference ICH Guideline: Q6B
参照ICH指南：Q6B
3.2.S.3 Characterisation (name, manufacturer)
3.2.S.3 3.2.S.3.1 Elucidation of Structure and other Characteristics (name,
manufacturer)
3.2.S.3.1
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.
应提供依据合成路线和光谱分析的结构确认信息。应包括潜在的异构化、立体化学的鉴定、
潜在的形成多晶型的信息。 Reference ICH Guideline: Q6A
参照ICH指南：Q6A
Biotech:
For desired product and product-related substances, details should be provided on
primary, secondary and higher-order structure, post-translational forms (e.g.,
glycoforms), biological activity, purity, and immunochemical properties, when relevant.
对于所定产品和产品的相关物质，应提供一级、二级和更高级结构、转化后的晶型（如
glycoforms）生物活性、纯度和免疫特征等相关特征。
Reference ICH Guideline: Q6B
参照ICH指南：Q6B
3.2.S.3.2 Impurities (name, manufacturer)
3.2.S.3.2 Information on impurities should be provided.
应提供杂质信息。
Reference ICH Guidelines: Q3A, Q3C, Q5C, Q6A, and Q6B
参照ICH指南：Q3A、Q3C、Q5C、Q6A和Q6B。
3.2.S.4 Control of Drug Substance (name, manufacturer)
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3.2.S.4 3.2.S.4.1 Specification (name, manufacturer)
3.2.S.4.1 The specification for the drug substance should be provided.
应提供原料药质量标准。
Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B。
3.2.S.4.2 Analytical Procedures (name, manufacturer)
3.2.S.4.2 The analytical procedures used for testing the drug substance should be provided.
应提供用于原料药检测的分析规程。 Reference ICH Guidelines: Q2A and Q6B
参照ICH指南：Q2A和Q6B
3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)
3.2.S.4.3 Analytical validation information, including experimental data for the analytical
procedures used for testing the drug substance, should be provided.
应提供分析验证信息，包括用于原料药检测的分析规程的实验数据。
Reference ICH Guidelines: Q2A, Q2B, and Q6B
参照ICH指南：Q2A、Q2B和Q6B
3.2.S.4.4 Batch Analyses (name, manufacturer)
3.2.S.4.4 Description of batches and results of batch analyses should be provided.
应提供批分析的批次和结果。
Reference ICH Guidelines: Q3A, Q3C, Q6A, and Q6B
参照ICH指南：Q3A、Q3C、Q6A和Q6B 3.2.S.4.5 Justification of Specification (name, manufacturer)
3.2.S.4.5 Justification for the drug substance specification should be provided.
应提供原料药质量标明。
Reference ICH Guidelines: Q3A, Q3C, Q6A and Q6B
参照ICH指南：Q3A、Q3C、Q6A和Q6B 3.2.S.5 Reference Standards or Materials (name, manufacturer)
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Information on the reference standards or reference materials used for testing of the drug
substance should be provided.
应提供用于原料药检测的参照标准品或参照物质的信息。
Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
3.2.S.6 Container Closure System (name, manufacturer)
3.2.S.6 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.
应提供容器密封系统的描述，包括对内包括材质的鉴定及其质量标准。质量标准应包括描述或鉴
定（及图的关键尺寸，如适用）。应包括非药典方法（验证），适用时。
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.
对于非功能性二级包装材料（如那些没有提供额外保护），仅提供简单描述。对于功能性能二级
包装材料，应提供额外的信息。
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.
应讨论关于，如包装材料的选择、防潮和避光、原料药的结构与包装材料的相容性，包括容器的
吸附和溶淋，和或包装物料的安全性。 3.2.S.7 Stability (name, manufacturer)
3.2.S.7 3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer)
3.2.S.7.1 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.
应总结所进行研究的类型、采用的方案和研究的结果。总结应包括结果，如，强制降解和强制条
件，以及与贮存条件、复检日期和货架寿命等相关资料。
Reference ICH Guidelines: Q1A, Q1B, and Q5C
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
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The Common Technical Document - Quality The post-approval stability protocol and stability commitment should be provided.
应提供批准后的稳定性方案和稳定性建议。 Reference ICH Guidelines: Q1A and Q5C
参照ICH指南：Q1A和Q5C
3.2.S.7.3 Stability Data (name, manufacturer)
3.2.S.7.3
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.
应以适当的格式如表格、图形或叙述的形式提供稳定性研究（如，强制降解和强制条件）的结
果。应包含用于生成这些数据的分析规程以及对这些规程的验证信息。
Reference ICH Guidelines: Q1A, Q1B, Q2A, Q2B, and Q5C
参照ICH指南：Q1A、Q1B、Q2A、Q2B和Q5C 3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)
3.2.P
3.2.P.1 Description and Composition of the Drug Product (name, dosage form)
3.2.P.1 A description of the drug product and its composition should be provided. The information
provided should include, for example:
应提供制剂的描述及其组份。这些信息应包括，如：
2 of the dosage form; , Description
,
, Composition, i.e., list of all components of the dosage form, and their amount on a per-
unit basis (including overages, if any) the function of the components, and a reference to
their quality standards (e.g., compendial monographs or manufacturer’s specifications)
, 组份，如，制剂的所有组份清单，及单包装的数量（包装多出的量，如有），组份的功效、
质量标准的出处（如药典的专论或厂商的质量标准） , Description of accompanying reconstitution diluent(s); and
, 附加的稀释剂的描述；和
, Type of container and closure used for the dosage form and accompanying reconstitution
diluent, if applicable.
, 剂型的容器及密封件类型和附加的稀释剂，适当时。 Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
2 For a drug product supplied with reconstitution diluent(s), the information on the diluent(s)
should be provided in a separate part “P”, as appropriate
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The Common Technical Document - Quality
3.2.P.2 Pharmaceutical Development (name, dosage form)
3.2.P.2 The Pharmaceutical Development section should contain information on the development
studies conducted to establish that the dosage form, the formulation, manufacturing
process, container closure system, microbiological attributes and usage instructions are
appropriate for the purpose specified in the application. The studies described here are
distinguished from routine control tests conducted according to specifications. Additionally,
this section should identify and describe the formulation and process attributes (critical
parameters) that can influence batch reproducibility, product performance and drug
product quality. Supportive data and results from specific studies or published literature
can be included within or attached to the Pharmaceutical Development section. Additional
supportive data can be referenced to the relevant nonclinical or clinical sections of the
application.
药学研究章节应包含开发研究的信息，包括为了建立剂型、处方、生产工艺、容器密封系统、适
用的微生物的属性和使用说明。这里所说的研究与根据质量标准进行的常规控制检查不同。另
外，这节应确定并描述处方和能够影响批重现性、产品性能和药品质量的工艺属性（关键参
数）。特定研究的支撑数据和结果或出版的文献可包含在药学研究章节中或附在其后。附加的数
据可参照相关的临床或非临床应用。 Reference ICH Guidelines: Q6A and Q6B
参照ICH指南：Q6A和Q6B
3.2.P.2.1 Components of the Drug Product (name, dosage form)
3.2.P.2.1
3.2.P.2.1.1 Drug Substance (name, dosage form)
原料药（名称、厂商） 3.2.P.2.1.1
The compatibility of the drug substance with excipients listed in 3.2.P.1 should be
discussed. Additionally, key physicochemical characteristics (e.g., water content,
solubility, particle size distribution, polymorphic or solid state form) of the drug
substance that can influence the performance of the drug product should be
discussed.
应讨论原料药和辅料的相容性列在3.2.P.1中。此外，还应讨论能够影响药品性能的原料
药的关键理化性质（如，含水量、溶解性、粒径分布、多晶型或固态等）。
For combination products, the compatibility of drug substances with each other
should be discussed.
对于复方制剂，应该讨论各原料药之间的相容性。
3.2.P.2.1.2 Excipients (name, dosage form)
3.2.P.2.1.2 辅料（名称、剂型）
The choice of excipients listed in 3.2.P.1, their concentration, their characteristics
that can influence the drug product performance should be discussed relative to
their respective functions.
例在3.2.P.1中的辅料的选择，及浓度、影响药品性能的特征，相关辅料各自的功能也应
讨论。
3.2.P.2.2 Drug Product (name, dosage form)
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3.2.P.2.2
3.2.P.2.2.1 Formulation Development (name, dosage form)
剂型研究（名称，剂型） 3.2.P.2.2.1
A brief summary describing the development of the drug product should be provided,
taking into consideration the proposed route of administration and usage. The
differences between clinical formulations and the formulation (i.e. composition)
described in 3.2.P.1 should be discussed. Results from comparative in vitro studies
(e.g., dissolution) or comparative in vivo studies (e.g., bioequivalence) should be
discussed when appropriate.
应简述药品研究，考虑给定的给药途径和用法。应讨论临床剂型平共处和3.2.P.1中所述
剂型的区别。适当时要讨论体外研究（如溶出度等）或体内研究（生物等效性）的结果对
照。
3.2.P.2.2.2 Overages (name, dosage form)
3.2.P.2.2.2 超量（名称，剂型）
Any overages in the formulation(s) described in 3.2.P.1 should be justified.
应说明3.2.P.1中所述处方的超量。
3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)
3.2.P.2.2.3 理化和生物学特性（名称、剂型）
Parameters relevant to the performance of the drug product, such as pH, ionic
strength, dissolution, redispersion, reconstitution, particle size distribution,
aggregation, polymorphism, rheological properties, biological activity or potency,
and/or immunological activity, should be addressed.
应讨论与药品性能相关的参数，如pH、离子浓度、溶出度、再分散性、粒径分布、凝
集、多晶型、流变学特征、生物活性或效价，和/或免疫活性等。
3.2.P.2.3 Manufacturing Process Development (name, dosage form)
3.2.P.2.3 The selection and optimisation of the manufacturing process described in 3.2.P.3.3, in
particular its critical aspects, should be explained. Where relevant, the method of
sterilisation should be explained and justified.
就解释3.2.P.3.3中所述生产工艺选择和优化，尤其是关键方面。相关时应解释并说明灭菌方
法。
Differences between the manufacturing process(es) used to produce pivotal clinical batches
and the process described in 3.2.P.3.3 that can influence the performance of the product
should be discussed.
应讨论用于生产中枢临床批次的生产工艺和3.2.P.3.3中所述能够影响产品性能的工艺之间的区
别。
3.2.P.2.4 Container Closure System (name, dosage form)
3.2.P.2.4
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The suitability of the container closure system (described in 3.2.P.7) used for the storage,
transportation (shipping) and use of the drug product should be discussed. This discussion
should consider, e.g., choice of materials, protection from moisture and light, 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 drug product).
应讨论用于贮存、运输和药品使用的容器密封系统（在3.2.P.7中描述）的适用性。该讨论应针
对包装材质的选择、防潮和避光、制剂组份及包装材质的相容性（包括容器的吸附性和溶解
性）、包装材质的安全性、性能（如当药物输送设施作为药品的一部分时剂量的重现性）。
3.2.P.2.5 Microbiological Attributes (name, dosage form)
3.2.P.2.5 Where appropriate, the microbiological attributes of the dosage form should be discussed,
including, for example, the rationale for not performing microbial limits testing for non-
sterile products and the selection and effectiveness of preservative systems in products
containing antimicrobial preservatives. For sterile products, the integrity of the container
closure system to prevent microbial contamination should be addressed.
适当时，应讨论制剂的微生物学属性，包括，例如，不进行微生物限度检查的非无菌产品和含有
抗菌防腐剂的产品中防腐剂的选择及抗菌效果的基本原理。对于无菌产品，应讨论容器密封系统
的完好性以预防微生物污染。 3.2.P.2.6 Compatibility (name, dosage form)
3.2.P.2.6 The compatibility of the drug product with reconstitution diluent(s) or dosage devices (e.g.,
precipitation of drug substance in solution, sorption on injection vessels, stability) should be
addressed to provide appropriate and supportive information for the labeling.
应说明有稀释剂或剂量设施（如，原料药在溶液中沉淀、注射容器的吸附、稳定性）的药品相容
性为标签提供适当的支撑信息。 3.2.P.3 Manufacture (name, dosage form)
3.2.P.3 3.2.P.3.1 Manufacturer(s) (name, dosage form)
3.2.P.3.1 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.
应提供每个生产商包括
协议
离婚协议模板下载合伙人协议 下载渠道分销协议免费下载敬业协议下载授课协议下载
者，以及每一个涉及生产和检测的生产地址或工厂的姓名、地址和职
责。
3.2.P.3.2 Batch Formula (name, dosage form)
3.2.P.3.2
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A batch formula should be provided that includes a list of all components of the dosage form
to be used in the manufacturing process, their amounts on a per batch basis, including
overages, and a reference to their quality standards.
应提供批处方，包括生产工艺中使用的制剂所有组份清单，一个批次的量，包括超量，以及质量
标准参考。
3.2.P.3.3 Description of Manufacturing Process and Process Controls (name,
dosage form)
3.2.P.3.3 A flow diagram should be presented giving the steps of the process and showing where
materials enter the process. The critical steps and points at which process controls,
intermediate tests or final product controls are conducted should be identified.
应提供流程图，给出工艺步骤并显示物料在什么地方进入工艺。应确定进行工艺控制、中间体检
查或成品控制的关键步骤和关键点。
A narrative description of the manufacturing process, including packaging, that represents
the sequence of steps undertaken and the scale of production should also be provided. Novel
processes or technologies and packaging operations that directly affect product quality
should be described with a greater level of detail. Equipment should, at least, be identified
by type (e.g., tumble blender, in-line homogeniser) and working capacity, where relevant. 还应提供生产工艺描述，能代表步骤的顺序和生产规模的工艺，包括包装。 应详细描述直接影响
产品质量的工艺、技术和包装操作。设备至少应标明类型（如）和工作能力。
Steps in the process should have the appropriate process parameters identified, such as
time, temperature, or pH. Associated numeric values can be presented as an expected
range. Numeric ranges for critical steps should be justified in Section 3.2.P.3.4. In certain
cases, environmental conditions (e.g., low humidity for an effervescent product) should be
stated.
工艺步骤应标明适当的工艺参数，如时间、温度或pH。相关数值可以一个预期的范围值出现。关键步骤的数值应在3.2.P.3.4中说明。在特定情况下，应指明环境条件（如，泡腾产品应处于
低湿度下）。
Proposals for the reprocessing of materials should be justified. Any data to support this
justification should be either referenced or filed in this section (3.2.P.3.3).
应说明物料返工方案。任何能够支持这一说明的数据都既要参考又要编入本节（3.2.P.3.3）。
Additionally for Biotech see 3.2.A.1 for facilities, if appropriate.
此外对于生物制品，适当时还要参见3.2.A.1设施部分。 Reference ICH Guideline: Q6B
参照ICH指南：Q6B
3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)
3.2.P.3.4 Critical Steps: Tests and acceptance criteria should be provided (with justification,
including experimental data) performed at the critical steps identified in 3.2.P.3.3 of the
manufacturing process, to ensure that the process is controlled.
关键步骤：应提供在3.2.P.3.3中确定的生产工艺的关键步骤中进行的检查和接受标准（要有说
明，包括实验数据），以保证工艺是受控的。
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The Common Technical Document - Quality
Intermediates: Information on the quality and control of intermediates isolated during the
process should be provided.
中间体：应提供工艺过程中分离的中间体的质量和控制信息。
Reference ICH Guidelines: Q2A, Q2B, Q6A, and Q6B
参照ICH指南：Q2A，Q2B，Q6A和Q6B 3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)
3.2.P.3.5 / Description, documentation, and results of the validation and/or evaluation studies should
be provided for critical steps or critical assays used in the manufacturing process (e.g.,
validation of the sterilisation process or aseptic processing or filling). Viral safety
evaluation should be provided in 3.2.A.2, if necessary.
应提供关键步骤或用于生产工艺中的关键含测的验证描述、文件和结果和/或评估研究。必要时应
在3.2.A.2中提供病毒安全性评估资料。 Reference ICH Guideline: Q6B
参照ICH指南：Q6B
3.2.P.4 Control of Excipients (name, dosage form)
3.2.P.4 3.2.P.4.1 Specifications (name, dosage form)
3.2.P.4.1 The specifications for excipients should be provided.
应提供辅料质量标准。
Reference ICH Guideline: Q6A and Q6B
参照ICH指南：Q6A和Q6B
3.2.P.4.2 Analytical Procedures (name, dosage form)
3.2.P.4.2 The analytical procedures used for testing the excipients should be provided, where
appropriate.
适当时应提供用于辅料检测的分析规程。 Reference ICH Guidelines: Q2A and Q6B
参照ICH指南：Q2A和Q6B
3.2.P.4.3 Validation of Analytical Procedures (name, dosage form)
3.2.P.4.3 Analytical validation information, including experimental data, for the analytical
procedures used for testing the excipients should be provided, where appropriate.
适当时要提供分析验证信息应包括实验数据、用于检测辅料的分析规程。
Reference ICH Guidelines: Q2A, Q2B, and Q6B
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参照ICH指南：Q2A，Q2B和Q6B 3.2.P.4.4 Justification of Specifications (name, dosage form)
3.2.P.4.4 Justification for the proposed excipient specifications should be provided, where appropriate.
适当时应提供即定辅料质量标准的说明。 Reference ICH Guidelines: Q3C and Q6B
参照ICH指南：Q3C和Q6B
3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form)
3.2.P.4.5
For excipients of human or animal origin, information should be provided regarding
adventitious agents (e.g., sources, specifications; description of the testing performed; viral
safety data). (Details in 3.2.A.2).
应提供人和动物来源的辅料的信息，针对外来试剂（如来源、质量标准、检测描述、病毒安全性
数据）。（详情见3.2.A.2）.
Reference ICH Guidelines: Q5A, Q5D, and Q6B
参照ICH指南：Q5A，Q5D和Q6B 3.2.P.4.6 Novel Excipients (name, dosage form)
3.2.P.4.6 For excipient(s) used for the first time in a drug product or by a new route of administration,
full details of manufacture, characterisation, and controls, with cross references to
supporting safety data (nonclinical and/or clinical) should be provided according to the drug
substance format. (Details in 3.2.A.3).
对于第一次用于药品中的辅料或通过新的给药途径用药时，应按照原料药格式（详情见
3.2.A.3）提供详细的生产、特征和控制信息，同时要参照引用安全性支撑数据（非临床和/或临
床）。（详情见3.2.A.3）。
3.2.P.5 Control of Drug Product (name, dosage form)
3.2.P.5 3.2.P.5.1 Specification(s) (name, dosage form)
3.2.P.5.1 The specification(s) for the drug product should be provided.
应提供药品质量标准。
Reference ICH Guidelines: Q3B, Q6A and Q6B
参照ICH指南：Q3B，Q6A和Q6 3.2.P.5.2 Analytical Procedures (name, dosage form)
3.2.P.5.2 The analytical procedures used for testing the drug product should be provided.
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应提供用于药品检验的分析规程。
Reference ICH Guidelines: Q2A and Q6B
参照ICH指南：Q2A和Q6B
3.2.P.5.3 Validation of Analytical Procedures (name, dosage form)
3.2.P.5.3 Analytical validation information, including experimental data, for the analytical
procedures used for testing the drug product, should be provided.
应提供验证信息，包括实验数据、用于药品检测的分析规程。
Reference ICH Guidelines: Q2A, Q2B and Q6B.
参照ICH指南：Q2A，Q2B和Q6B
3.2.P.5.4 Batch Analyses (name, dosage form)
3.2.P.5.4 A description of batches and results of batch analyses should be provided.
应提供批描述和批分析结果。
Reference ICH Guidelines: Q3B, Q3C, Q6A, and Q6B
参照ICH指南：Q3B，Q3C，Q6A和Q6B 3.2.P.5.5 Characterisation of Impurities (name, dosage form)
3.2.P.5.5 Information on the characterisation of impurities should be provided, if not previously
provided in "3.2.S.3.2 Impurities".
应提供杂质特征信息，如果在3.2.S.3.2杂质中没有提供。
Reference ICH Guidelines: Q3B, Q5C, Q6A, and Q6B
参照ICH指南：Q3B，Q5C，Q6A和Q6B 3.2.P.5.6 Justification of Specification(s) (name, dosage form)
3.2.P.5.6 Justification for the proposed drug product specification(s) should be provided.
应提供即定质量标准的说明。
Reference ICH Guidelines: Q3B, Q6A, and Q6B
参照ICH指南：Q3B，Q6A和Q6B
3.2.P.6 Reference Standards or Materials (name, dosage form)
3.2.P.6
Information on the reference standards or reference materials used for testing of the drug
product should be provided, if not previously provided in "3.2.S.5 Reference Standards or
Materials".
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应提供用于药品检测的参考标准品和对照物质的信息，如果在3.2.S.5参考标准品和对照物质中
没有提供。
Reference ICH Guidelines: Q6A and Q6B
对照ICH指南：Q6A和Q6B
3.2.P.7 Container Closure System (name, dosage form)
3.2.P.7 A description of the container closure systems should be provided, including the identity of
materials of construction of each primary packaging component and its specification. The
specifications should include description and identification (and critical dimensions, with
drawings where appropriate). Non-compendial methods (with validation) should be
included where appropriate.
应提供容器密封系统的描述，包括对一级包装材料的鉴定及其质量标准。质量标准应包括描述和
鉴别（及关键尺寸，适当时以图示）。需要时要提供非药典方法（附验证）。
For non-functional secondary packaging components (e.g., those that neither provide
additional protection nor serve to deliver the product), only a brief description should be
provided. For functional secondary packaging components, additional information should be
provided.
对于非功能性的二级包装（如，那些既没有提供附加保护又不用于药物分散的包装），只提供简
要的描述。对于功能性的二级包装，要提供附加信息。 Suitability information should be located in 3.2.P.2.
适用性信息应位于3.2.P.2。
3.2.P.8 Stability (name, dosage form)
3.2.P.8
3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)
3.2.P.8.1 The types of studies conducted, protocols used, and the results of the studies should be
summarized. The summary should include, for example, conclusions with respect to storage
conditions and shelf-life, and, if applicable, in-use storage conditions and shelf-life.
应总结进行的研究的类型、采用的方案以及研究结果。总结应包括，如，与贮存条件和货架寿命
相关的结论，以及，如适用，使用的贮存条件和货架寿命。
Reference ICH Guidelines: Q1A, Q1B, Q3B, and Q5C, Q6A
参照ICH指南：Q1A，Q1B，Q3B和Q5C，Q6A 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name,
dosage form)
3.2.P.8.2
The post-approval stability protocol and stability commitment should be provided.
应提供批准后的稳定性方案和稳定性建议。 Reference ICH Guidelines: Q1A and Q5C
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对照ICH指南：Q1A和Q5C
3.2.P.8.3 Stability Data (name, dosage form)
3.2.P.8.3 Results of the stability studies should be 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 should be included.
应以适当的格式（如表格、图形、叙述）提供稳定性研究结果。应包括分析规程，以及对这些规
程的验证信息。
Information on characterisation of impurities is located in 3.2.P.5.5.
杂质特征信息位于3.2.P.5.5。
Reference ICH Guidelines: Q1A, Q1B, Q2A, Q2B and Q5C
参照ICH指南：Q1A，Q1B，Q2A和Q5C。 3.2.A APPENDICES
3.2.A
3.2.A.1 Facilities and Equipment (name, manufacturer)
3.2.A.1 Biotech:
A diagram should be provided illustrating the manufacturing flow including movement
of raw materials, personnel, waste, and intermediate(s) in and out of the
manufacturing areas. Information should be presented with respect to adjacent areas
or rooms that may be of concern for maintaining integrity of the product.
应提供流程图，描绘生产流程，包括原材料流动、人员、废物和中间体进出生产区域。应提
示与保持产品完好性有关的相邻区域或房间的信息。
Information on all developmental or approved products manufactured or manipulated
in the same areas as the applicant's product should be included.
应包括所有开发或批准的产品在同一区域生产、放大的信息。
A summary description of product-contact equipment, and its use (dedicated or multi-
use) should be provided. Information on preparation, cleaning, sterilisation, and
storage of specified equipment and materials should be included, as appropriate.
应提供对直接接触产品的设备及其用途（专用或多用）的描述。适当时应包括特定设备和物
料的制备、清洁、灭菌及贮存信息。
Information should be included on procedures (e.g., cleaning and production scheduling)
and design features of the facility (e.g., area classifications) to prevent contamination
or cross-contamination of areas and equipment, where operations for the preparation of
cell banks and product manufacturing are performed.
在细胞库制备和产品生产区域，应提供操作规程（如清洁和生产计划）和厂房
设计
领导形象设计圆作业设计ao工艺污水处理厂设计附属工程施工组织设计清扫机器人结构设计
特征
（如，区域分级）以预防生产区和设备染菌或效叉污染。
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3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form,
manufacturer)
3.2.A.2
Information assessing the risk with respect to potential contamination with adventitious
agents should be provided in this section.
应在本节提供外来试剂潜要污染的风险评估。 For non-viral adventitious agents:
Detailed information should be provided on the avoidance and control of non-viral
adventitious agents (e.g., transmissible spongiform encephalopathy agents, bacteria,
mycoplasma, fungi). This information can include, for example, certification and/or testing
of raw materials and excipients, and control of the production process, as appropriate for
the material, process and agent.
应提供关于避免和控制非病毒外来试剂（如，TSE试剂，细菌，支原体，真菌）的详细信息。该信息应包括，如，原材料和辅料的确认和/或检验，生产工艺控制，适当时还要针对物料、工艺和试剂。
Reference ICH Guidelines: Q5A, Q5D, and Q6B
对照ICH指南：Q5A，Q5D和Q6B
For viral adventitious agents:
Detailed information from viral safety evaluation studies should be provided in this section.
Viral evaluation studies should demonstrate that the materials used in production are
considered safe, and that the approaches used to test, evaluate, and eliminate the potential
risks during manufacturing are suitable. The applicant should refer to Q5A, Q5D, and
Q6B for further guidance.
本节应提供病毒安全性评估研究的详细信息。病毒安全性评估研究应证明用于生产的物料是安全
的，以及生产中用于检测、评价和消除潜在风险的途径是合适的。申请者应参考Q5A，Q5D和
Q6B指南。
Materials of Biological Origin
生物来源物料
Information essential to evaluate the virological safety of materials of animal or human
origin (e.g. biological fluids, tissue, organ, cell lines) should be provided. (See related
information in 3.2.S.2.3, and 3.2.P.4.5). For cell lines, information on the selection,
testing, and safety assessment for potential viral contamination of the cells and viral
qualification of cell banks should also be provided. (See related information in 3.2.S.2.3).
应提供动物和人来源（如生物液体、组织、器官和细胞系）物料的病毒安全性评估的必要
性。（见3.2.S.2.3和3.2.P.4.5中相关信息）。对于细胞系，还应提供细胞潜在的病毒污染
及细胞库中病毒定量的安全性评估。（见3.2.S.2.3中相关信息）。
Testing at appropriate stages of production 生产的合适阶段的检测
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The selection of virological tests that are conducted during manufacturing (e.g., cell
substrate, unprocessed bulk or post viral clearance testing) should be justified. The
type of test, sensitivity and specificity of the test, if applicable, and frequency of testing
should be included. Test results to confirm, at an appropriate stage of manufacture,
that the product is free from viral contamination should be provided. (See related
information in 3.2.S.2.4 and 3.2.P.3.4 ).
应说明生产过程中（如细胞基质、未处理原料药或清除病毒后的检测）进行病毒测试的选
择。应包括检测类型、检测的灵敏度和专属性，如适用，还应包括检测频率。应提供适当生
产阶段（免于病毒污染）中，对检测结果的确认。（见3.2.S.2.4和3.2.P.3.4中相关信
息）。
Viral Testing of Unprocessed Bulk 未处理原料药病毒检测
In accordance with Q5A and Q6B, results for viral testing of unprocessed bulk should
be included.
根据Q5A和Q6B，应包括未处理原料药的病毒检测结果。
Viral Clearance Studies
病毒清除研究
In accordance with Q5A, the rationale and action plan for assessing viral clearance and
the results and evaluation of the viral clearance studies should be provided. Data can
include those that demonstrate the validity of the scaled-down model compared to the
commercial scale process; the adequacy of viral inactivation or removal procedures for
manufacturing equipment and materials; and manufacturing steps that are capable of
removing or inactivating viruses. (See related information in 3.2.S.2.5 and 3.2.P.3.5).
根据Q5A，应提供评价病毒清除的原理和行动计划及病毒清除研究结果和评估。数据可包括
那些能够证明小规模与商业规模相比的有效性；对于生产设备和物料病毒充分灭活或除去的
规程；能够去除或灭活病毒的生产步骤。（见3.2.S.2.5和3.2.P.3.5中相关信息）。
Reference ICH Guidelines: Q5A, Q5D, and Q6B
参照ICH指南：Q5A，Q5D和Q6B
3.2.A.3 Excipients
3.2.A.3
3.2.R REGIONAL INFORMATION
3.2.R
Any additional drug substance and/or drug product information specific to each region
should be provided in section R of the application. Applicants should consult the
appropriate regional guidelines and/or regulatory authorities for additional guidance.
在申请的R部分中应提供对于每一个区域的任何附加原料药和/或药品的信息。申请人应咨询适
当的区域指南和/或法规机构以获得附加指南。 Some examples are as follows:
下面给出一些例子：
, Executed Batch Records (USA only)
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, USA , Method Validation Package (USA only)
, USA , Comparability Protocols (USA only)
, USA , Process Validation Scheme for the Drug Product (EU only)
, EU Where validation is still to be completed, a summary of the studies intended to be
conducted should be provided.
当需要完成验证时，应提供要进行的研究的总结。
, Medical Device (EU only)
, EU
3.3 LITERATURE REFERENCES
3.3
Key literature referenced should be provided, if applicable.
适用时，应提供关键参考文献。
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