对假药以及原辅料等造假风险较高的地区，采取哪些措施予以控制。
- Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis;
委托生产和委托检验及其他项目委托情况
- List of contract manufacturers and laboratories including the addresses and contact information and flow charts of supply-chains for outsourced manufacturing and Quality Control activities; e.g. sterilization of primary packaging material for aseptic processes, testing of starting raw materials etc, should be presented in Appendix 4;
合同生产企业和实验室名单，包括以下信息：地址、联系方式、委托生产和质量检验活动的供应链流程图；例如：无菌工艺产品所用内包装材料灭菌、起始物料的检验等均应在附录4中予以表述清楚；
- Brief overview of the responsibility sharing between the contract giver and acceptor with respect to compliance with the Marketing Authorisation (where not included under 2.2).
简述委托方和受托方在产品放行中的责任（不包括在2.2中）。
2.4 Quality Risk Management (QRM)
质量风险管理（QRM）
- Brief description of QRM methodologies used by the manufacturer; 简述企业质量风险管理方法
- Scope and focus of QRM including brief description of any activities which are performed at corporate level, and those which are performed locally. Any application of the QRM system to assess continuity of supply should be mentioned.
按公司不同层级（集团和生产厂）简述质量风险管理的范围和重点，包应提及任何评估供应持续性的质量风险管理体系应用。
3. Personnel 人员
- Organisation chart showing the arrangements for quality management, production and quality control positions/titles in Appendix 5, including senior management and Authorised Person(s) / Qualified Person(s);
企业质量管理、生产和质量控制及其负责人的组织机构图，包括高级管理层和授权人等（附件5）；
- Number of employees engaged in the quality management, production, quality control, storage and distribution respectively.
从事质量管理、生产、质量控制、储存及分销的员工数量。
4. Premises and Equipment 厂房和设备
4.1 Premises
厂房
- Short description of plant; size of the site and list of buildings. If the production for different markets, i.e. for local, EU, USA, etc. takes place
in different buildings on the site, the buildings should be listed with destined markets identified (if not identified under 1.1);
简述生产工厂情况，包括场地面积和各建筑物名称等，如不同建筑物生产的 品种面向当地以及欧盟、美国等不同市场，应在特定市场的建筑物上注明（如 未在1.1明确）
- Simple plan or description of manufacturing areas with indication of scale (architectural or engineering drawings are not required); Lay outs and flow charts of the production areas (in Appendix 6) showing the room classification and pressure differentials between adjoining areas and indicating the production activities (i.e.compounding, filling, storage, packaging, etc.) in the rooms;
简述生产区域规模情况，附厂区总平面布局图、生产区域的平面布局图和流向图，标明比例（不需要建筑或工程图纸）。应当标注出房间的洁净级别、相邻房间的压差，并且能指示房间所进行的生产活动（例如：配料、灌装、储存、包装等）（附件6）；
Lay-outs of warehouses and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitising materials indicated, if applicable;
仓库和储存区域的平面图，如果有，包括储存和处理高毒性、危险性与敏感物料的特殊区域。
- Brief description of specific storage conditions if applicable, but not indicated on the lay-outs.
如有，请简述特殊储存条件情况，但不需在平面图上注明。
4.1.1 Brief description of heating, ventilation and air conditioning (HVAC) systems
简述空调净化（HVAC）系统
- Principles for defining the air supply, temperature, humidity, pressure differentials and air change rates, policy of air recirculation (%).
简述空调净化系统设计原则，如送风、温度、湿度、压力差以及换气次数、回风等(%)。
4.1.2 Brief description of water systems
简要描述水系统
- Quality references of water produced; 水质设计标准
- Schematic drawings of the systems in Appendix 7. 水系统示意图附录7
4.1.3. Brief description of other relevant utilities, such as steam, compressed air,nitrogen,
etc.
简要描述其他相关公用设施，例如蒸汽、压缩空气、氮气等系统。
4.2 Equipment
设备
4.2.1 Listing of major production and control laboratory equipment with critical
pieces of equipment identified should be provided in Appendix 8. 列出生产和检验用主要仪器、设备附录8。 4.2.2 Cleaning and sanitation
清洁与消毒
- Brief description of cleaning and sanitation methods of product contactsurfaces (i.e.
manual cleaning, automatic Clean-in-Place, etc).
简述与药品直接接触设备、工器具的表面清洗、消毒方法及验证情况（例如：人工清洁、自动在线清洁等）。
4.2.3 GMP critical computerised systems
与药品生产质量相关的关键计算机化系统
- Description of GMP critical computerised systems (excluding equipment
specific Programmable Logic Controllers (PLCs)).
简述与药品生产质量相关的关键的计算机化系统情况（不包括逻辑编程器（PLCs））。 5. Documentation 文件
- Description of documentation system (i.e. electronic, manual); 描述企业的文件系统（例如电子、纸质）；
- When documents and records are stored or archived off-site (including pharmacovigilance data, when applicable): List of types of documents/records; Name and address of storage site and an estimate of time required retrieving documents from the off-site archive.
如文件和记录在生产工厂外保存（如有，包括药物警戒数据），请提供外存的文件/记录目录、储存场所的名称和地址以及从厂区外取回文件所需的时间。
6. Production 生产
6.1 Type of products
产品类型
(references to Appendix 1 or 2 can be made): （可参考附件1或2）：
- Type of products manufactured including 生产品种类型
? list of dosage forms of both human and veterinary products which are manufactured on the site
工厂生产剂型一览表（包括人用与兽用产品）
? list of dosage forms of investigational medicinal products (IMP) manufactured for any clinical trials on the site, and when different from the commercial manufacturing, information of production areas and personnel
工厂生产临床试验用药品（IMP）剂型一览表，如生产场所与上市生产品种不同，请
提供生产区域和生产人员信息。
- Toxic or hazardous substances handled (e.g. with high pharmacological activity and/or with sensitising properties);
毒性或危险物质的处理情况（如高活性和/或高致敏药品）；
- Product types manufactured in a dedicated facility or on a campaign basis, if applicable;
如有，请说明专用设备或阶段生产制造产品情况；
- Process Analytical Technology (PAT) applications, if applicable: general statement of the relevant technology, and associated computerised systems.
如有，请说明过程分析技术（PAT）应用情况，并概述相关技术和计算机化系统应用情况。
6.2 Process validation
工艺验证
- Brief description of general policy for process validation; 简要描述工艺验证的原则；
- Policy for reprocessing or reworking. 返工或重新加工的原则。
6.3 Material management and warehousing
物料管理和仓储
- Arrangements for the handling of starting materials, packaging materials, bulk and finished products including sampling, quarantine, release and storage;
起始物料、包装材料、半成品与成品的处理，包括取样、待检、放行与储存； - Arrangements for the handling of rejected materials and products. 不合格物料和产品的处理
7. Quality Control (QC) 质量控制
- Description of the Quality Control activities carried out on the site in terms of physical, chemical, and microbiological and biological testing. 描述理化检验、微生物及生物学检验等质量控制活动。
8. Distribution, Complaints, Product Defects and Recalls 分销、投诉、产品缺陷与召回
8.1 Distribution(to the part under the responsibility of the manufacturer)
分销（属于制造商职责内的部分）
- Types (wholesale licence holders, manufacturing licence holders, etc) and
locations (EU/EEA, USA, etc.) of the companies to which the products are shipped from the site;
-
-
- -
分销商类型（包括是否持有经营许可证或制造许可证等）及其所在地区（欧盟/欧洲经济区、美国等）；
Description of the system used to verify that each customer / recipient is legally entitled to receive medicinal products from the manufacturer;
描述用来确认顾客/接受者的系统，以证明顾客有合法资格接收药品； Brief description of the system to ensure appropriate environmental conditions during transit, e.g. temperature monitoring/ control;
简要描述产品在运输过程中确保其符合贮存条件要求的措施，例如： 温度监测/监控；
Arrangements for product distribution and methods by which product traceability is maintained;
产品分销管理以及确保其可追踪的方法。
-Measures taken to prevent manufacturers’ products to fall in the illegal supply chain
防止产品流入非法供应链的措施。
8.2 Complaints, product defects and recalls
投诉、产品缺陷与召回
- Brief description of the system for handling complains, product defects and recalls.
简要描述投诉处理、产品缺陷与召回系统。
9. Self Inspections 自检
- Short description of the self inspection system with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities.
简要描述企业自检系统，重点说明自检计划中涉及范围的选择标准、自检实施以及整改情况。
相关附件：
Appendix 1 Copy of valid manufacturing authorisation 附件1 有效的制造许可文件复印件
Appendix 2 List of dosage forms manufactured including the INN-names or common name (as available) of active pharmaceutical ingredients (API) used
附件2 所有生产剂型目录，包括所用原料药的INN名称或通用名（如有）
Appendix 3 Copy of valid GMP Certificate 附件3 有效的GMP证书复印件
药品医疗器械境外检查管理规定征求意见稿
