WHO技术报告系列第908号附录6GMP检查报告指南,2003年译本1_工厂检查报告填写指南
WHO技术报告系列第908号附录6GMP检查报告指南,2003年译本1由刀豆文库小编整理，希望给你工作、学习、生活带来方便，猜你可能喜欢“工厂检查报告填写指南”。
World Health Organization 世界卫生组织
WHO Technical Report Series, No.908, 2003 WHO技术报告系列第908号，2003年
Annex 6 附录6 Guidance on Good Manufacturing Practices(GMP): inspection report GMP检查报告指南
When a site at which pharmaceutical products are manufactured is inspected, the inspector(s)responsible must draw up a report containing the items listed below.Where relevant, the appropriate section of the WHO GMP(Annex 4)is indicated.当药品生产场所进行检查时，检查员有责任草拟包含下文所列项目的报告。有关内容，在WHO GMP（附录4）部分进行说明
A.Manufacturer 生产企业
(a)Name of inspected manufacturer.被检查的企业名称
(b)Addre of inspected manufacturer(including telephone, fax, email and 24-hour telephone numbers).被检查企业的地址（包括电话、传真、e-mail和24小时电话号码）(c)Addre of manufacturing site if different from that given above.生产场所的地址（如果与上述不一致）
(d)Site number(e.g.site master file or number allocated by the responsible authority).生产场所的注册号（如：生产场所主文件或当地行政机关分配的号码）(e)Manufacturing licence number, if applicable.生产执照号，如果有(f)Activities.业务
(g)Pharmaceutical products manufactured.所生产的药品(h)Key personnel.关键人员
(i)Key persons met.会见的关键人员
B.Inspection details 检查细节
(a)Date(s)of inspection(s).检查日期
(b)Previous inspection date.上次检查日期
(c)Type of inspection.检查方式(d)Scope of inspection.检查范围
(e)The regulatory authority.行政机关
(f)GMP guidelines used for aeing compliance.用于评估符合性的GMP指南
(g)For foreign inspections state whether, the national regulatory authority(NRA)of the country where the inspection took place was informed and whether it took part in the inspection.进行海外检查时，是否通知被检查企业所在国的国家行政机构和该国机构是否参与检查。
(h)Brief report of inspection activities undertaken.简要报告检查的过程
(i)Samples taken and results obtained.取样及所得结果
(j)Aement of the site master file.生产场所主文件评估情况
(k)GMP-related recalls from the market of any product in the last 2 years.最近2年GMP有关的任何产品从市场收回的情况
C.Inspector(s)检查员
(a)Name(s)of inspector(s)and accompanying experts.检查员的姓名和陪同专家
D.Introduction 介绍
(a)Brief summary of the manufacturing activities.简要汇总生产情况
(b)Other manufacturing activities carried out on the site(e.g.manufacture of cosmetics, research and development).生产场所其他的生产情况(如：化妆品生产，研究和开发)(c)Use of outside scientific, analytical, or other technical aistance in manufacture and quality control.使用外部科研、分析或其他在生产和质量控制方面的技术支持(d)Brief description of the quality management system of the firm responsible for manufacture.Reference can be made to a site master file if one is available.简要描述企业关于生产的职责的质量管理体系。如果可能可以作为生产场所主文件的附件提供。
E.Observations 观察情况
The observations made during the inspection that are considered to be non-compliant with GMP should be listed.Where positive observations are included in the report, clear distinction should be made between “positive” and “non-compliant”.Non-compliant observations can be claified, e.g.as “critical”, “major” and “minor” if the Member State concerned has defined these terms.The date by which corrective 2 action and completion are requested in accordance with the policy of the national regulatory authority should be given.在检查过程中发现的被认为不符合GMP的情况应罗列出来。在报告中也应包括好的方面，应明显区分符合和不符合。应对不符合项进行评定，如：象“严重”、“主要”、“轻微”，如果有关成员国有这些定义。整改的日期和按照国家行政机构政策的要求完成整改。
E.1 Quality aurance(see WHO GMP, section 1)质量保证（见WHO GMP, section 1)(a)Quality system and documented quality policy of the manufacturer, e.g.as described in the quality manual.质量体系和生产企业文件化的质量政策，如质量手册等 E.2 Organization and personnel
机构和人员(see WHO GMP, section 9)(a)Organizational chart showing the arrangements for quality aurance, including production and quality control.表明质量保证机构的组织机构图，包括生产部门和质量控制部门(b)Qualifications, experience and responsibilities of key personnel.关键人员的资格、经验和职责
(c)Outline of arrangements for basic and in-service training and method of keeping records.基本机构的概述和在职培训和保持记录的方法
(d)Health requirements for personnel engaged in production.参与生产人员的健康要求
(e)Personnel hygiene requirements, including clothing.人员卫生要求包括着装
E.3 Premises(see WHO GMP, section 12)厂房(见WHO GMP，第12节)(a)Manufacturing areas(design, location etc.)used e.g.for storage and manufacturing(e.g.weighing, production, packaging)and flow of personnel and material.使用的生产区域（设计，位置等）如：储存区和生产区（如：称量、生产、包装）和人流、物流。
(b)Special areas for the handling of highly toxic, hazardous and sensitizing materials.处理高毒性、高危险性和高致敏物料的专门区域。(c)Nature of construction and finishes.厂房结构和内表面的性质
(d)Systems such as drainage, ventilation, air conditioning, and supply of steam and gas.Detailed description of critical areas with potential risks of contamination and cro-contamination.系统如排水、通风、空调和蒸汽和气体的供应等。详细描述有污染和交叉污染潜在风险的关键区域。
(e)Claification of the rooms used for the manufacture of products, including clean rooms.用于药品生产房间的级别，包括洁净房间(f)Water systems.水系统(g)Planned preventative maintenance programme.已计划的预防性维修程序
(h)Qualification of premises and systems as appropriate.厂房和系统的确认
E.4 Equipment(see WHO GMP, section 13)设备(见WHO GMP，第13节)(a)Design, location and adaptation of equipment used in production and control laboratories.生产和控制实验室的设备的设计、定位和选用
(b)Planned preventative maintenance programmes for equipment and records.已计划的预防性设备维修程序和记录
(c)Qualification and calibration, including records.确认和校验，包括记录
E.5 Materials(see WHO GMP, section 14)物料(见WHO GMP，第14节)(a)Sourcing of materials.物料来源
(b)Control, storage and handling of materials, including: 物料的控制、储存和处理，包括： — starting materials;— 起始物料
— packaging materials;— 包装材料
— intermediate and bulk products;— 中间体和大包装产品 — finished products;— 成品
— returned and rejected materials;— 退货和拒收物料
— reagents and culture media;— 试剂和培养基
— reference standards;— 对照品
— waste material.— 废弃物
E.6 Good practices in production(see WHO GMP, section 16)良好的生产规范(见WHO GMP，第16节)(a)Transport, handling and use of starting materials, packaging materials, and bulk and finished products.起始物料、包装材料、大包装产品和成品的运输、处理和使用
(b)Production operations and important parameters(e.g.sampling, quarantine, weighing, proce operations and conditions, acceptance limits).生产操作和重要参数（如：取样、隔离、称量、工艺操作和条件，可接受的限度）(c)Validation(e.g.proce).验证（如：工艺）
(d)Change control and deviation reporting.变更控制和偏差报告
E.7 Quality control(see WHO GMP, section 17)质量控制(见WHO GMP，第17节)(a)Activities of quality control(including quarantine control, sampling, chemical and microbial analysis).质量控制活动（包括隔离控制、取样、化学和微生物分析）(b)Organization and personnel.组织和人员(c)Premises.场所
(d)Equipment and instrumentation.仪器和设备(e)Materials.物料
(f)Documentation(e.g.specifications, procedures, reports, records).文件（如：标准、程序、报告、记录）
E.8 Sanitation and hygiene(see WHO GMP, section 3)卫生设施和卫生（见WHO GMP，第3节）
(a)Procedures for sanitation and/or cleaning(e.g.of premises and equipment)and records.卫生和/或清洁程序（如：厂房、设备的）和记录(b)Personal hygiene.人员卫生
E.9 Validation(see WHO GMP, section 4)验证(见WHO GMP，第4节)(a)Validation master plan.验证主计划
(b)Validation and qualification protocols and reports for qualification and validation(e.g.of premises, systems, equipment, proce, computer, cleaning, analytical methods).验证和确认方案和报告（如：厂房设施、系统、设备、工艺、计算机、清洁的、分析方法）
(c)Stages of validation.验证的状况
(d)Types of validation.验证类型
E.10 Documentation(see WHO GMP, section 15)文件(见WHO GMP，第15节)(a)Documentation(e.g.specifications, procedures, records, protocols, reports).文件（如：标准、工艺、记录、方案、报告）(b)Preparation, revision and distribution of documentation.文件的制定、审核和分发
(c)Reports on production, quality control(including environmental control), engineering and other relevant areas.生产，质量控制(包括环境控制)，工程和其他相关方面）的报告
E.11 Complaints(see WHO GMP, section 5)投诉(见WHO GMP，第5节)(a)Procedure, records and investigation.程序、记录和调查
E.12 Product recalls(see WHO GMP, section 6)产品召回(见WHO GMP，第6节)(a)Procedure, records and investigation.程序、记录和调查
E.13 Contract production and analysis(see WHO GMP, section 7)委托生产和检验(见WHO GMP，第7节)(a)Responsibilities of contract giver.委托方的责任
(b)Responsibilities of contract accepter.受托方的责任
(c)Contract(containing clearly defined responsibilities).合同（包含明确划分责任的内容）
(d)GMP compliance of the contract accepter(initial aement and continued compliance audited at regular intervals).受托方GMP的符合性（初次评估和定期持续符合性审查）
E.14 Self-inspection and quality audits(see WHO GMP, section 8)自检和质量审计(见WHO GMP，第8节)(a)Procedure, programme and compliance.程序、符合性
(b)Items for self-inspection.自检项目
(c)Self-inspection team.自检小组
(d)Frequency of self-inspection.自检频率
(e)Self-inspection report.自检报告
(f)Follow-up action.后续行动(g)Quality audit.质量审计
(h)Suppliers’ audits.供应商审计 F.Summary 汇总
Brief summary of the findings, and recommendations(where applicable).简要汇总发现的问题和建议
G.Conclusions 总结
A statement regarding the GMP status.关于GMP实施的情况
Name: _____________ Signature:____________ Date: __________ 姓名
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