CTD格式要求(英文版)

2. 3. P DRUG PRODUCT (NAME, DOSAGE FORM)

2.3.P.1 Description and Composition of the Drug Product

（1）A description of the dosage of drug product and its composition should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table.

(2) If there is special dissolvent, please fill the table as above.

(3) Description of container and material of package.

2.3.P.2Pharmaceutical Development

Summarize the purpose of the development, including dosage, strength and reason of the selection.

2.3.P.2.1 Components of the Drug Product

2.3.P.2.1.1 Drug substance

Summarize the compatibility of the drug substance with excipients. Refer to 3.2.P.2.1.1 (Page: ) for the details.

Additionally, summarize key physicochemical characteristics (e.g., solubility, particle size distribution, or crystal form) of the drug substance that can influence the performance of the drug product and also the control of all this characteristics.

2.3.P.2.1.2 Excipients

Generally introduce the types and the tests and/ or reference of amount selection. Refer to 3.2.P.2.1.2 (Page: ) for the details.

2.3.P.2.2Pharmaceutical Development

2.3.P.2.2.1 Formulation Development

Refer to 3.2.P.2.2.1(Page: ) for the process of formulation development and supporting

information.

A tabulated summary of the variation and reasons of formulation of different development steps, as well as supporting validation tests should be provided. For example:

Excessive feeding: Supporting information about excessive feeding.

2.3.P.2.2.2 Properties of drug products

Summary relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, polymorphism, rheological properties, should be addressed.

The quality comparative tests results between the products and innovator in the formulation development should be provided. For example:

(1)Dissolution of oral solid preparations: batch number, batch number and manufacture of

the innovator; condition of dissolution, sampling points; comparative tests results.

(2)Related substance: batch number, batch number and manufacture of the innovator;

methods of tests and calculation; comparative tests results.

2.3.P.2.3 Manufacturing Process Development

Refer to 3.2.P.2.3(Page: ) for the details of the selection and optimization of manufacturing process.

A tabulated summary of the variation and related supporting research information from lab scale tests to large scale tests, including batch size, devices, parameters, etc. should be provided.

Example:

Summary of the variation of manufacturing process

Summarized the sample condition of representative batches (including but not limited to clinical research batch, pilot scale batch, on-site verification batch, process validation batch). Batch number, manufacture date and address, batch scale, purpose (eg. Stability tests, BE tests, etc.), analysis results(eg. Related substance, dissolution and other quality indications) Example:

Summary of batch analysis

2.3.P.2.4 Packing material/ Container

*including material and strength

**including the accessories which contact the drug directly, such as c ombined with polypropylene plastic containers infusion and plastic containers with polypropylene interface infusion

Refer to 3.2.P.2.4 (Page: ) for the details.

2.3.P.2.5 Compatibility

Summarize the compatibility of the drug product with diluent(s) or dosage devices. Refer to 3.2.P.

2.5 (Page: ) for the details.

2.3.P.3 Manufacture

2.3.P.3.1 Manufactures

The name (full name), address, telephone number and fax of each manufacturer and each proposed production site or facility involved in manufacturing and testing should be provided.

2.3.P.3.2 batch formula

A description of the composition of drug product in scale for production should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table.

2.3.P.3.3 Manufacturing Process and Process Controls

(1) flow diagram of process: refer to 3.2.P.3.3 (Page: )

(2) description of manufacturing process: Main processes, parameters and scales should be identified by a brief description of each manufacturing process (including steps). Refer to 3.2.P.3.3 (Page: )

(3) Main equipments: Refer to 3.2.P.3.3 (Page: )

(4) draft scale of large production: units of drug product/batch (oral preparation, etc. ) or volume of solution before filled/batch (solution, injection, etc).

2.3.P.3.4 Controls of Critical Steps and Intermediates

List all the critical steps and the parameter control ranges of manufacture process

Refer to 3.2.P.3.4 for the details of identification of critical steps and the parameter control ranges of manufacture process.

Refer to 3.2.P.3.4 for the details of quality control of intermediates

2.3.P.3.5 Process Validation and Evaluation

aseptic and specified processing preparation: protocol of process validation (No. version number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: )

other preparation: protocol of process validation (No. version number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: ); Otherwise, protocol of process validation (No. version number: ) and report of batch production (No. version number: ). Refer to 3.2.P.3.5 for the details of draft and validation undertaking (Page: )

2.3.P.4Control of Drug substance and Excipients

2.3.P.5Control of Drug Product

2.3.P.5.1 Specification

A tabulated summary of specification should be provided as below. If there are release and shelf life specification, please explain each one in the table. Refer to 3.2.P.5.1(Page: ) for the details of specification.

2.3.P.5.2 analysis methods

List chromatographic condition of each method: degradation substance, resident solvent, assay, etc.

List the dissolution condition and quantitative method, etc.

Refer to 3.2.P.5.2 for the details of analysis methods.

2.3.P.5.3 Validation of Analytical Procedures

The validation results should be tabulated as following:

Example:

Method validation of related substance

Refer to 3.2.P.5.3 (Page: )

2.3.P.5.4 Certificate of analysis

Refer to 3.2.P.5.4(Page: ) for the COAs of 3 batches(batch number: )

2.3.P.5.5 Impurity analysis

A tabulated summary of impurities should be supplied.

For example:

Analysis of impurities

Refer to 3.2.P.5.5 for the details(Page: )

2.3.P.5.6 Justification of Specification

Refer to 3.2.P.5.6 for the details(Page: )

2.3.P.6 Reference Standards

Pharmacopoeia Reference: resource, batch number

Working standard: summarize the methods and results of standardization of assay and purification

2.3.P.7 Stability

2.3.P.7.1 Summary of stability

(1) sample:

(2) tests

Stability results

In-use stability results

2.3.P.7.2 Post-marketing stability commitment and protocol

Refer to 3.2.P.7.2 for the details (Page: )

Draft packing material, storage condition and shelf-life should be listed as follow:

2.3.P.7.3 Raw data of stability

Tabulate the tests results, and refer to 3.2.P.7.2 for the details(Page: ) Example:

CTD格式申报资料撰写要求

国食药监注〔2010〕387 号附件： 化学药品CTD格式申报资料撰写要求

CTD格式申报主要研究信息汇总表（原料药） 2.3.S.1 基本信息 2.3.S.1.1 药品名称 原料药的中英文通用名、化学名 2.3.S.1.2 结构 原料药的结构式、分子式、分子量 2.3.S.1.3 理化性质 原料药的主要物理和化学性质：性状(如外观，颜色，物理状态)；熔点或沸点；比旋度，溶解性，溶液pH, 分配系数，解离常数，将用于制剂生产的物理形态（如多晶型、溶剂化物、或水合物），生物学活性等。 2.3.S.2 生产信息 2.3.S.2.1 生产商 生产商的名称（一定要写全称）、地址以及生产场所的地址。 2.3.S.2.2 生产工艺和过程控制 （1）工艺流程图：参见申报资料3.2.S.2.2（注明页码）。 （2）工艺描述：按反应路线简述各步反应的反应类型（氧化、还原、取代、缩合、烃化、酰化等），各步反应的原料、试剂、溶剂和产物的名称，终产物的精制方法和粒度控制等；特殊的反应条件（如高温、高压、深冷等）应说明。详细容参见申报资料3.2.S.2.2（注明页码）。 （3）生产设备：参见申报资料3.2.S.2.2（注明页码）。 （4）大生产的拟定批量：kg（g）/批。 2.3.S.2.3 物料控制 生产用物料（如起始物料、反应试剂、溶剂、催化剂等）的质量控制信息（包括来源、质量标准等），参见申报资料3.2.S.2.3（注明页码）。 2.3.S.2.4 关键步骤和中间体的控制 列出所有关键步骤及其工艺参数控制围。 关键步骤确定依据参见申报资料3.2.S.2.4或3.2.S.2.6（注明页码）。 中间体的质量控制参见申报资料3.2.S.2.4（注明页码）。 2.3.S.2.5 工艺验证和评价 无菌原料药：工艺验证方案（编号：--，版本号：--）和验证报告（编号：--，版本号：--）参见申报资料3.2.S.2.5（注明页码）。 其他原料药：工艺验证方案（编号：--，版本号：--）和验证报告（编号：--，版本号：--）参见申报资料3.2.S.2.5（注明页码）；或者，工艺验证方案（编号：--，版本号：--）和批生产记录（编号：--，版本号：--）样稿参见申报资料3.2.S.2.5（注明页码），验证承诺书参见申报资料3.2.S.2.5（注明页码）。 2.3.S.2.6 生产工艺的开发 简要说明工艺路线的选择依据（例如参考文献或自行设计），简要描述工艺开发过程中生产工艺的主要变化（包括批量、设备、工艺参数以及工艺路线等的变化）。详细信息参见申报资料3.2.S.2.6（注明页码）。 提供工艺研究数据汇总表，示例如下：

英文论文格式要求

附件1： 英文论文格式要求 1.论文排版要求 论文需报送全文，文稿请用Word录入排版，A4版面，单倍行距，页边距上下各2.5 cm、左右各2 cm，页眉页脚取默认值，插入页码居中。全文字数不超过5000字，版面不超进5页。全文使用Time New Roman字体。 2.文章结构 论文应依次包含论文题目、作者姓名、作者单位及通讯地址、摘要、关键词、正文、参考文献、作者简介等。 3.论文题目 三号字体、加粗，居中排；副标题另起一行，小三加粗；英文题目中，所有实词的首字母大写（虚词小写）。 4.作者姓名 作者姓名用四号字体、居中排，多位作者之间用逗号区分，姓大写、加粗，名首字母大写，中间不加连字符，段前空1行。 5.作者单位及通讯地址 作者单位及通讯地址用五号字体、居中排，全部内容置于括号中，段后空一行。 6.摘要 “Abstract”一词五号加粗，内容五号字体。不少于200个词，用过去时态叙述作者工作，用现在时态叙述作者结论。 — 1 —

7.关键词 “Keywords”一词五号加粗，内容五号字体。英文关键词之间用逗号，需列出3～5个。 （正文之前的所有内容左右各缩进2字符。） 8.正文 五号Time New Roman通排，首行缩进1字符，采用单倍行距；文中所用计量单位，一律按国际通用标准或国家标准，如hm2，kg等；文中年代、年月日、数字一律用阿拉伯数字表示。 文中各级标题采用阿拉伯数字分级编序，一律左顶格排版。一级标题四号字体加粗，形如1，2，3，…排序；二级标题小四号字体加粗，形如1.1，1.2，…排序；三级标题五号字体加粗，形如1.1.1，1.1.2，…排序。各级标题数字后空1全角空格，段前段后各空0.5行，当两级标题在一起时，两级标题之间不空行。 文中图、表应有自明性，且随文出现。图以10幅为限。尽量采用Word文档以插入表格方式制作三线表。图（表）须有图（表）题，紧随文后，且在同一页面。图中文字、符号或坐标图中的标目、标值须写清。标目应使有符合国家标准的物理量和单位符号。表的内容切忌与插图和文字内容重复。 表题五号字体加粗，排表上居中，段前1行，段后0.5行；表栏头五号字体，各栏居左；表序号按流水排序，表格后空1行。图题五号字体加粗，排图下居中，段前1行，段后0.5行；图注小五号字体，排图题下居中，接排。图文、表文五号字体。 — 2 —

HEALTH AND SAFETY HANDBOOK 健康与安全手册英文版

HEALTH AND SAFETY HANDBOOK Issue 1/April 2012

CONTENTS OFFICE SAFETY 1 1. INTRODUCTION 1 2. HEALTH AND SAFETY AT WORK ACT 1 Legal Requirements 1 3. GENERAL REQUIREMENTS 1 Environment 1 4. SICKNESS 2 5. ACCIDENT/HAZARD REPORTING 2 6. FIRE 2 FIRE ACTION 3 FIRE EVACUATION PROCEDURES 3 7. VDU/DISPLAY SCREEN EQUIPMENT 3 8. OTHER OFFICE EQUIPMENT 4 9. LIFTING AND HANDLING 4 10. FIRST AID 4 11. ELECTRICAL SAFETY 错误！未定义书签。 12. SECURITY 5 13. GOOD PRACTICE 5 14. TRAINING 6 15. GENERAL WELL BEING 6 FIRST AIDERS 7 USEFUL WEB SITES 错误！未定义书签。 USEFUL CONTACTS 错误！未定义书签。FIRE EVACUATION PROCEDURES 8

HEALTH AND SAFETY IN OFFICES 1. INTRODUCTION Oxford Brookes University Health and Safety Manual is produced by the University’s Health and Safety Division in accordance with the Health and Safety at Work Act 1974(Section 2), Workplace health, Safety & Welfare Regulations 19921. This .......... Division Health and Safety Handbook has been produced to be a `user friendly’ guide for all Division staff. However, health and safety is a serious matter and this handbook is designed to complement the University’s Health and Safety Manual. All staff must take the time to read and understand the University’s health and safety documents. The Health and Safety Manual is available in the School/Directorate main office and on-line. This handbook will be revised in line with any changes to the Health and Safety Manual and government regulations/guidelines. More specific details can be found within the Health and Safety Manual, with the relevant corresponding pages identified in the boxed sections. All members of the .......... Division will be given a copy of this handbook, which they should read and understand. A copy will also be sent by email that can be read on screen and the web addresses identified easily accessed. 2. HEALTH AND SAFETY AT WORK ACT Legal Requirements The Legal requirements as outlined in the University’s Health and Safety Manual identifies that under the Workplace Health, Safety and Welfare Regulations 1992, that it is the employers responsibility to ensure the health, safety and welfare at work of all employees . In addition, it is the responsibility of the Head of the School/Directorate to make necessary arrangements to ensure the health, safety and welfare at work of all employees. 3. GENERAL REQUIREMENTS Environment The place in which you work should ? Be a safe, clean and comfortable place. ? Have good ventilation with a source of Fresh or Purified’ air. ? The office should attain a minimum legal temperature of 16°C after the first hour. 1 The Stationery Office Limited, The Workplace (Health, Safety and Welfare) Regulations 1992, ISBN 0110258045

实操手册文字部分格式规范

实操手册文字部分格式规范 一、格式要求 1.每个段落（包括各级小标题）段首缩进4字符，回行顶格。 2.正文各层级标题命名如下： 第一章第1级标题（居中题） 第一节第2级标题（居中题） 一、第3级标题（边题或居中题） （一）第4级标题（边题） 1.第5级标题（边题或段首题） （1）第6级标题（段首题或无标题） ①第7级标题（段首题无标题） 标题层次可以跳跃使用，但下一级标题层级不可高于上一级标题。 要提前确定排入目录的最低一级标题层级。例如，若确定了进目录的最小一级标题是“一、”级，那么凡大于或等于“一、”级的标题都要进目录，而小于“一、”级的标题就不能进目录。 同一级别的标题应对齐，下一级标题不得超出上一级标题。 3.原则上各级标题均应分段，当第6、7级标题为无标题时，可根据标题后内容多少酌情选择是否分段。 4.当某一段落层次中包含至少一个下一级标题时，该段落层次结束后应空1行。 5.表格、图片前后均应空1行，表格、图片题目应居中放置。 6.正文行间距不可过小或过大，应保持在XX左右。 二、标点符号要求 1.按照正确方法使用各种标点符号。（详见附件1） 2.排版时，逗号、句号、顿号、冒号、问号、感叹号、分号等标点符号不可位于行首。 3.在正文的中文部分应使用中文标点符号，不得出现英文标点符号。引用的英文应使用英文标点符号。

4.边提、居中题、段首题末尾一般不使用句号、冒号等标点符号，排版时应注意删去。 5.表格中每一单元格中内容的结尾处不使用标点符号，非结尾处可以使用标点符号。 三、字体字号要求 1.各级标题字体及字号要求如下： XXXXXXXX（可用表格形式呈现） 2.下一级标题字号原则上不得大于上一级标题。 3.案例部分字体为XX，字号XX；案例分析部分字体为XX，字号XX。 4.图片标题字体XX，字号XX；图释字体XX，字号XX；表格标题字体XX，字号XX。 5.同一本手册中字母、数字使用的字体、格式应正确、统一。 6.第3、4级标题字体原则上应加粗，其他层级的标题可酌情加粗或改变字体颜色。

CTD格式申报资料撰写格式(制剂)

CTD格式申报资料撰写格式（制剂） 3.2.P.1 剂型及产品组成 3.2.P.2 产品开发 3.2.P.2.1 处方组成 3.2.P.2.1.1 原料药 3.2.P.2.1.2 辅料 3.2.P.2.2 制剂 3.2.P.2.2.1 处方开发过程 3.2.P.2.2.2 制剂相关特性 3.2.P.2.3 生产工艺的开发 3.2.P.2.4 包装材料/容器 3.2.P.2.5 相容性 3.2.P.3 生产 3.2.P.3.1 生产商 3.2.P.3.2 批处方 3.2.P.3.3 生产工艺和工艺控制 3.2.P.3.4 关键步骤和中间体的控制 3.2.P.3.5 工艺验证和评价 3.2.P.4 原辅料的控制 3.2.P.5 制剂的质量控制 3.2.P.5.1 质量标准 3.2.P.5.2 分析方法 3.2.P.5.3 分析方法的验证 3.2.P.5.4 批检验报告

3.2.P.5.5 杂质分析 3.2.P.5.6 质量标准制定依据 3.2.P.6 对照品 3.2.P.7稳定性 3.2.P.7.1 稳定性总结 3.2.P.7.2上市后的稳定性研究方案及承诺3.2.P.7.3 稳定性数据

二、申报资料正文及撰写要求 3.2.P.1 剂型及产品组成 （1）说明具体的剂型，并以表格的方式列出单位剂量产品的处方组成，列明各成分在处方中的作用，执行的标准。如有过量加入的情况需给予说明。对于处方中用到但最终需去除的溶剂也应列出。 （2）如附带专用溶剂，参照以上表格方式列出专用溶剂的处方。 （3）说明产品所使用的包装材料及容器。 要求：列出所有辅料的组成和用量（若含增塑剂，需说明增塑剂用量的合理性），包括包衣辅料等； 3.2.P.2 产品开发 提供相关的研究资料或文献资料来论证剂型、处方组成、生产工艺、包装材料选择和确定的合理性，具体为： 技术要求：简要说明产品开发目标，包括剂型/规格选择依据；简要描述背景资料，市场导向，国内外上市情况，专利、产品说明书，制剂处方组成、相关标准等资料的调研； 并以列表的形式提出开发目标（QTTP），包含：（1）预期的临床用途，给药途径、剂型、给药系统；（2）剂量规格（3）容器密闭系统（4）影响药代动力学和质量的关键属性（如：溶出度）（5）适合于拟上市产品的药品质量标准（如：纯度、稳定性和药物溶出）；

CTD格式要求

附件2 药品注册申报资料的体例与整理规范 为加强药品注册纸质申报资料的规范管理，特制定本规范。当申报资料同时进行CTD格式提交时，纸质申报资料的体例设臵必须与CTD申报格式电子文档相一致。 1.申报资料的体例要求 1.1字体、字号、字体颜色、行间距离及页边距离 1.1.1字体 中文：宋体英文：Times New Roman 1.1.2字号 中文：不小于小4号字，表格不小于5号字；申报资料封面加粗4号；申报资料目录小4号，脚注5号字。 英文：不小于12号字。 1.1.3字体颜色 黑色 1.1.4行间距离及页边距离 行间距离：单倍。 纵向页面：左边距离不小于2.5厘米、上边距离不小于2厘米、其他边距不小于1厘米。 横向页面：上边距离不小于2.5厘米、右边距离不小于2厘米、其他边距不小于1厘米。 页眉和页脚：信息在上述页边距内显示，保证文本在打印或装订中不丢失信息。

1.2纸张规格 申报资料使用国际标准A4型（297mm×210mm）规格、纸张重量80g,纸张全套双面或全套单面打印，内容应完整、清楚，不得涂改。 1.3纸张性能 申报资料文件材料的载体和书写材料应符合耐久性要求。 1.4加盖印章 1.4.1除《药品注册申请表》、相关受理文件及检验机构出具的检验报告外，申报资料应逐个封面加盖申请人印章（多个申请人联合申报的，应加盖所有申请人印章），封面与骑缝处加盖临床研究基地有效公章，封面印章应加盖在文字处。 1.4.2加盖的印章应符合国家有关用章规定，并具法律效力。 2.申报资料的整理要求 2.1申报资料封面 2.1.1申报资料袋封面 2.1.1.1档案袋封面注明：申请分类、注册分类、药品名称、本袋所属第X 套第X袋每套共X袋、原件/复印件联系人、联系电话、申请单位名称。 2.1.1.2申报资料袋封面（档案袋）应采用国家局统一格式（条码信息）的封面。 2.1.1.3多规格的品种为同一册申报资料时，申报资料袋封面，需显示多规格的条形码的受理号（同一封面）。 2 2.1.2申报资料项目封面

英文版手册格式要求

英文版手册格式要求 （一）页边距：上：3厘米，下2.5厘米，左：1.9厘米，右：1.9厘米，装订线：0厘米，装订线位置：左。 （二）页眉页脚：页眉顶端距离：1.5厘米，页脚低端距离：1.5厘米。 1.页眉：页眉中间处需填写章节标题（如：前言），字体为Times New Roman五号不加粗，排版可根据字数调整，保持美观整齐；版本处编号：Times New Roman 五号不加粗，单倍行距。 注意：批准页，总经理声明，警告页无页眉横线，其余所有页眉均有页眉横线2.页脚：Times New Roman五号字体，不加粗，单倍行距（包括数字）。 （三）封面页：手册编号Times New Roman小四，不加粗，手册名称：Times New Roman字号根据版面调节，保持整齐美观即可，不加粗。 （四）批准页：手册编号Times New Roma小四（页眉处），不加粗。 手册名称：Times New Roman 字号根据版面调节，保持整齐美观即可，不加粗。局方批准：Times New Roman四号，不加粗。 公司批准：Times New Roman四号，不加粗。 （五）总经理声明、警告页： 标题行：Times New Roman三号，不加粗，前后各空一行（或者段前段后1行）。页眉中间不需填写“前言”字样，页眉无页眉横线。 因篇幅原因，两页正文处行间距可自行调整，但字体仍需使用Times New Roman 五号，数字及英文同样使用Times New Roman字体。 （六）修订记录、修订说明、换页记录、有效页清单： 标题行：Times New Roman三号，不加粗，前后各空一行（或者段前段后1行）；正文表格：简洁、整齐。 （七）目录： 标题行：Times New Roman三号，不加粗，前后各空一行（或者段前段后1行）正文：行间距：最小值22磅 前言部分Times New Roman五号字，对齐方式使用“分散对齐” 每章标题采用Times New Roman五号字，对齐方式“左对齐” 每章目录采用Times New Roman五号字，对齐方式“分散对齐” （八）正文内容： 1.正文序列号规定：

化学药品 CTD格式申报资料撰写要求

国食药监注…2010? 387 号附件： 化学药品CTD格式申报资料撰写要求

CTD格式申报主要研究信息汇总表（原料药） 2.3.S.1 基本信息 2.3.S.1.1 药品名称 原料药的中英文通用名、化学名 2.3.S.1.2 结构 原料药的结构式、分子式、分子量 2.3.S.1.3 理化性质 原料药的主要物理和化学性质：性状(如外观，颜色，物理状态)；熔点或沸点；比旋度，溶解性，溶液pH, 分配系数，解离常数，将用于制剂生产的物理形态（如多晶型、溶剂化物、或水合物），生物学活性等。 2.3.S.2 生产信息 2.3.S.2.1 生产商 生产商的名称（一定要写全称）、地址以及生产场所的地址。 2.3.S.2.2 生产工艺和过程控制 （1）工艺流程图：参见申报资料3.2.S.2.2（注明页码）。 （2）工艺描述：按反应路线简述各步反应的反应类型（氧化、还原、取代、缩合、烃化、酰化等），各步反应的原料、试剂、溶剂和产物的名称，终产物的精制方法和粒度控制等；特殊的反应条件（如高温、高压、深冷等）应说明。详细内容参见申报资料3.2.S.2.2（注明页码）。 （3）生产设备：参见申报资料3.2.S.2.2（注明页码）。 （4）大生产的拟定批量：kg（g）/批。 — 1 —

2.3.S.2.3 物料控制 生产用物料（如起始物料、反应试剂、溶剂、催化剂等）的质量控制信息（包括来源、质量标准等），参见申报资料 3.2.S.2.3（注明页码）。 2.3.S.2.4 关键步骤和中间体的控制 列出所有关键步骤及其工艺参数控制范围。 关键步骤确定依据参见申报资料3.2.S.2.4或3.2.S.2.6（注明页码）。 中间体的质量控制参见申报资料3.2.S.2.4（注明页码）。 2.3.S.2.5 工艺验证和评价 无菌原料药：工艺验证方案（编号：--，版本号：--）和验证报告（编号：--，版本号：--）参见申报资料3.2.S.2.5（注明页码）。 其他原料药：工艺验证方案（编号：--，版本号：--）和验证报告（编号：--，版本号：--）参见申报资料 3.2.S.2.5（注明页码）；或者，工艺验证方案（编号：--，版本号：--）和批生产记录（编号：--，版本号：--）样稿参见申报资料 3.2.S.2.5（注明页码），验证承诺书参见申报资料3.2.S.2.5（注明页码）。 2.3.S.2.6 生产工艺的开发 简要说明工艺路线的选择依据（例如参考文献或自行设计），简要描述工艺开发过程中生产工艺的主要变化（包括批量、设备、工艺参数以及工艺路线等的变化）。详细信息参见申报资料3.2.S.2.6（注明页码）。 提供工艺研究数据汇总表，示例如下： — 2 —

CTD格式申报资料范本

药品注册分类：化学药品六类 注册申请分类：仿制药品注册申请 药品名称：苯磺酸氨氯地平片（XX g、XX g） 资料项目名称：药学研究CTD格式申报资料 研究机构名称：XXX制药有限公司 研究机构地址：XXXXXXXXX 研究机构主要研究者：XXX 研究机构电话：XXX 注册申请联系人姓名：XXX 原始资料的保存地点：XXX制药有限公司 注册申请机构联系电话：XXXXXXXXX 药品注册申请人：XXX制药有限公司

苯磺酸氨氯地平片申报资料（药学部分） 目录 3.2.P.1 剂型及产品组成 (2) 3.2.P.2 产品开发 (3) 3.2.P.2.1 处方组成 (3) 3.2.P.2.1.1 原料药 (3) 3.2.P.2.1.2 辅料 (4) 3.2.P.2.2 制剂研究 (4) 3.2.P.2.2.1 处方开发过程 (4) 3.2.P.2.3 生产工艺的开发 (19) 3.2.P.2.4 包装材料/容器 (22) 2.3.P.2.5 相容性 (22) 3.2.P.3 生产 (22) 3.2.P.3.1生产商 (22) 3.2.P.3.2批处方 (22) 3.2.P.3.3 生产工艺和工艺控制 (23) 3.2.P.3.4 关键步骤和中间体的控制 (24) 3.2.P.3.5 工艺验证和评价 (25) 3.2.P.4 原辅料的控制 (30) 3.2.P.5 制剂的质量控制 (30) 3.2.P.5.1质量标准 (30) 3.2.P.5.2 分析方法 (30) 3.2.P.5.3 分析方法的验证 (33) 3.2.P.5.4 批检验报告 (92) 3.2.P.5.5 杂质分析 (96) 3.2.P.6 对照品 (99) 3.2.P.7 稳定性 (100) 3.2.P.7.1稳定性总结 (100) 3.2.P.7.2上市后的稳定性承诺和稳定性方案 (101) 3.2.P.7.3 稳定性数据 (101)

企业管理手册欧美企业员工手册英文版

版

Asia EMPLOYEE HANDBOOK

R ECEIPT OF E MPLOYEE H ANDBOOK Please sign this form and return it to Human Resources I have received a copy of the Char-Broil Asia Employee Handbook which is effective May 1, 2007. I understand this is for informational purposes only, and it is my responsibility to review and become familiar with all of the material contained in it. I further understand the content of this Handbook supersedes any and all handbooks, guidelines and personnel policies previously issued. Terms of a valid Employment Contract will supercede this document in cases in which the Employment Contract terms are different from those within this document. I also understand the company may supersede, change, eliminate or add to any policies, benefits or practices described in the Handbook at its discretion, with or without prior notice. I agree and understand this Handbook is not intended to create an express or implied contract of employment, nor does it guarantee my continued employment with the company. I further agree that my employment is “at will” and may be terminated at any time by me or the company, with or without prior notice and with or without cause. My signature below indicates that I have received my personal copy of the Handbook. Employee Signature_________________________________________________ Employee Name (printed)____________________________________________ Location__________________________________________________________ Date_____________________________________________________________

质量手册英文版

1 Control program of (management) document and data XLC/QP07.01-02 Page 1 Total: 2 pages 1.1 Aims and applicable scope In charge of documents and data about quality system and guarantee the related Dept. use the available edition. 1.2 Obligations 1.2.1 Quality Dept. is responsible for the delivering and controlling of quality manual and program file. 1.2.2 Every functional Dept. is in charge of the delivering and controlling of each files and dada. 1.3 Working Procedures 1.3.1 Classification and serial numbers of files and data 1.3.1.1 Controlled and uncontrolled files are divided into. Quality manual and programmed file the responsible belong to the controlled. “Controlled files checking list” should be proposed by people in related Dept and then checked by the director in that Dept. Finally, representative supervisor approve that. The controlled files should be marked with ID, numbers, whereas, the unrolled files on the contrary. 1.3.1.2 Quality Dept. makes “document number regulation” (without technical files) and that can be carried out after obtaining the approval of the representative supervisor. 1.3.2 Composing, examining, approving and delivering of documents 1.3. 2.1 The representative supervisors organize the composing of the quality manual and programmed files and the functional departments are responsible of composing each document. 1.3. 2.2 The representative supervisor check the quality manual and the General Manage approve it; every functional manages make a joint checkup for programmed files and directors approve those files; the other files should be checked by each functional supervisors according to sufficiency and adaptation. 1.3. 2.3 Quality manual and programmed files will be delivered by Quality Dept. and also by the data administrators “Borrowing files registration form”. The other files should be delivered in each functional department in the certain range. 1.3. 2.4 “Inner Notice” as the main form of XLC inner management document will be delivered in certain scope which is approved by examiner and the getters will sign on the original files and then get the copy one. 1.3.3 Altering and cancellation 1.3.3.1 The representative supervisor organizes the altering of quality manual and programmed files. After altering of the documentation, the altering marks and valid time will be given. The original files will be taken back document administrator in Quality Dept and the obvious marks will be stamped on. 1

CTD格式申报资料撰写要求(制剂)

CTD格式申报资料撰写要求（制剂） 一、目录 3.2.P.1 剂型及产品组成 3.2.P.2 产品开发 3.2.P.2.1 处方组成 3.2.P.2.1.1 原料药 3.2.P.2.1.2 辅料 3.2.P.2.2 制剂 3.2.P.2.2.1 处方开发过程 3.2.P.2.2.2 制剂相关特性 3.2.P.2.3 生产工艺的开发 3.2.P.2.4 包装材料/容器 3.2.P.2.5 相容性 3.2.P.3 生产 3.2.P.3.1 生产商 3.2.P.3.2 批处方 3.2.P.3.3 生产工艺和工艺控制 3.2.P.3.4 关键步骤和中间体的控制 3.2.P.3.5 工艺验证和评价 3.2.P.4 原辅料的控制 3.2.P.5 制剂的质量控制 3.2.P.5.1 质量标准 3.2.P.5.2 分析方法

3.2.P.5.3 分析方法的验证 3.2.P.5.4 批检验报告 3.2.P.5.5 杂质分析 3.2.P.5.6 质量标准制定依据 3.2.P.6 对照品 3.2.P.7 稳定性 3.2.P.7.1 稳定性总结 3.2.P.7.2 上市后的稳定性研究方案及承诺 3.2.P.7.3 稳定性数据 二、申报资料正文及撰写要求 3.2.P.1 剂型及产品组成 （1）说明具体的剂型，并以表格的方式列出单位剂量产品的处方组成，列明各成分在处方中的作用，执行的标准。如有过量加入的情况需给予说明。对于处方中用到但最终需去除的溶剂也应列出。 成分用量过量加入作用执行标准 工艺中使用到并最终去除的溶剂 （2）如附带专用溶剂，参照以上表格方式列出专用溶剂的处方。 （3）说明产品所使用的包装材料及容器。 3.2.P.2 产品开发

英文通知范文格式

英文通知范文格式 书面通知 是英语作文的一种常见类型。下面是小编帮大家整理的英文通知范文格式， 希望大家喜欢。 书面通知的英语作文格式要求 1.通知的标志：标志一般要醒目，多用 Notice 作标题。 2.出通知的单位和时间：一般分别位于正文的右下角和右上角。不过，这两 项有时可以省略。 3.通知的正文：要写明所做事情的具体时间、地点、概括性内容、出席对象 及有关注意事项。 4.通知的对象： 一般用第三人称， 但如果带有称呼语， 则用第二人称来表示。 5.通知的文体：注意用词贴切，语句简洁。 通知的英文格式范文(一) An English Evening to Be Held Notice It is our great desire to improve our English studies to a new stage。 So an English evening is going to be held in our school meeting-hall from 8:00 to 10:00 p。 m。 next Friday。 You will enjoy English stories， songs， poems and short plays at the evening。 Mr and Mrs Green from the USA working in our school， together with their children， will be invited to our evening。 They will give us wonderful performances。 All the teachers and students are welcome to attend our English evening。 We hope all of you will like the performances。 Student's Union Nov。 16， 1998 通知的英文格式范文(二) Dear classmates, I’ve something to tell you. The school League Committee has decided to organize a volunteer activity for the League members this weekend---to do general cleaning at the railway station . All the League members are

员工手册(英文版

PIC Sample Company Policies And Procedures January 2004 Printing Industries of California 5800 South Eastern Avenue, Suite 400 P.O. Box 910936 Los Angeles, CA. 90091-0936

Cost-PIC Member Free February 3, 2004 Non-Member $300 PURPOSE OF THIS SAMPLE Printing Industries of California (PIC) recognizes the value of well- written company personnel policies and procedures. Over the years PIC has published sample employee handbook language covering basic employment policies. Members have used this language as a guide in creating written policies and procedures covering the company’s employment practices and philosophies. This publication, like others before it, does not claim to be all- inclusive or a final product. New State and Federal laws and legal decisions will require this sample to be updated, along with the company's employee handbook, to reflect these changes. Further, each company must develop an employee handbook, which reflects the employment practices unique to the company's operation and philosophies. Consequently, a publication such as this sample must be flexible and open ended to accommodate these differences in employment practices and philosophies. In initiating or revising your company personnel policies or employee handbook, do not hesitate to call Doug Moore, Vice President of Human Resources, for assistance. Although an effort has been made to provide sample language, which is consistent with applicable law, employers using this or other language may wish to have a labor attorney review their employee handbook before publication. PIC would like to extend a special thanks to the Employment Law Department at the law firm of Silver & Freedman. They have provided a good portion of the language contained in this sample handbook and review its contents from time to time. (EDITOR’S NOTE: HEALTH BENEFITS FOR EMPLOYEES ON WORKERS’ COMPENSATION DISABILITY AND OTHER LEAVES)