NB : Reference : PA/PH/CEP (04) 1 (as revised) Content of the dossier for chemical purity and microbiological quality (can be downloaded from EDQM website http://www.edqm.eu)

quality overall summary

质量综述

Substance name产品名称
Monograph n°个论号
Subtitle (if any) 副标题（如果有的话）
Intended Holder of the CEP CEP证书持有人

Written by 撰写人
Qualification*资质
Date日期

(*) : append CV of the expert
quality overall summary

2.3.S DRUG SUBSTANCE原料药

2.3.S.1 General Information一般信息

Use of the substance :Route(s) of administration, maximum daily dose.

用途：（给药途径，每日最大剂量）

Commercialisation history: Summarise the history based on the table in application form).

贸易历史：（按申请表中的概述）

Declarations: Summarise the declarations appended to the application form:

声明：（概述附于申请表后的声明）

- Manufacture of the substance in accordance with ICH Q7A GMP rules

该原料药生产遵循了ICH Q7A GMP法规条款

- Commitment by the manufacturer to keep the proposed holder informed of any changes to the

documentation.

生产商的承诺：任何文件变更都会及时通知持有人

- if applicable : Manufacturer's authorisation for X to act as representative

生产商对某人作为代表人的授权书（如果有的话）

- Willingness to be inspected (holder, manufacturers)

愿意接受现场检查（持有人，生产商）

- Non-use/use of materials of human or animal origin in the process

生产过程中未使用/使用了来源于人或动物的物料

2.3.S.1.1 Nomenclature 命名

(a) Recommended International Non-proprietary name (INN):国际非专有名称

(b) Chemical name(s):化学名

(d) Other non-proprietary name(s) (e.g., national name, USAN, BAN):其他非专利名称（如，国家命名，美国采用名，英国认可名）

(e) CAS No. Molecular Formula分子式 MW: 分子量

2.3.S.1.3 General Properties特性

Give summarised data on:提供以下信息

(a) Physical description (e.g., appearance, colour, physical state…)

形状描述（如：外观、颜色、物理状态）

(b) Physical form (e.g., polymorphic form, solvate, hydrate): to be commented especially if requested as grade.

物理形态（如：多晶型，溶剂化物，水合物）：按要求分级别作出描述

溶解性，及其他相关特性

(d) Particle size:e.g. « non-micronised », « micronised » or any grade claimed as subtitle.

粒度（如：非微粒、微粒，或其他级别说明，作为小标题）

2.3.S.2 Manufacture生产

2.3.S.2.1 Manufacturer(s) (name, manufacturer) and sites involved in the entire process

生产商（产品名，公司名），及整个生产过程中涉及的场所

Give the name, address and responsibility of each manufacturer, including contractors and manufacturer and each proposed production site or facility involved in manufacture.

提供每个生产商的名称、地址、责任，包括承包商和生产商，以及生产过程涉及的每个拟定生产地点或设备

2.3.S.2.2 Description of Manufacturing Process and Process Controls

生产工艺和工艺控制的描述

(a) Give a brief narrative step-by-step description of the manufacturing process(es) and provide reference to detailed description in the documentation. Confirm the maximum batch size

简要工艺描述，提供记录中详细描述作为参考。证实最大批量。

(b) If applicable summarise alternate processes and give a short explanation of their use:

如果有的话，概述变更工艺，并简短说明原因

(c) Comment shortly on recovery of materials (solvents, reagents, and mother liquor) together with reprocessing steps and give a brief justification:

简单说明物料回收（溶剂、试剂和母液）和再回收步骤，并提供主要理由

2.3.S.2.3 Control of Materials物料控制

I) Starting material(s)起始物料

(a) Give summarised specifications (including impurities profile) including their justification based on studies of carry-over.

提供质量标准（包括杂质概况），并给出残留物研究的合理证明

NB :If starting material is obtained by fermentation or is from herbal origin, summarise the information related to the nature of this material.

注：如果起始物质为从发酵或植物提取中获得，概述这种物料性质的相关信息。

II) Reagents and solvents试剂和溶剂

Summarise the quality and controls of the materials (e.g., raw materials, solvents pure and/or recovered, reagents, catalysts) used in the manufacture of the drug substance.

概述原料药生产中用到的物料质量和控制信息（如：原材料，纯溶剂或回收溶剂，试剂，催化剂）

2.3.S.2.4 Controls of Critical Steps and Intermediates关键步骤和中间体的控制

Summary of the controls performed at critical steps of the manufacturing process and on intermediates, compare analytical procedures used for intermediates and final substance.

概述生产工艺以及对于中间体的关键步骤的控制信息，以及对中间体和最终产品的比较分析方法

2.3.S.2.5 Process Validation and/or Evaluation工艺验证和/或评估

For aseptic processing and sterilization only give the summary of process validation and/or evaluation studies.

对无菌操作和灭菌的工艺验证和/或评估提供概述