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GMP规范中英文对照

GMP规范中英文对照Chapter 1: General Provisions第一章总则Article 1: This Regulation is enacted in accordance with the "Drug Administration Law of The People's Republic of China".第一条根据《中华人民共和国药品管理法》规定，制定本规范。

Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products. This Regulation shall be applicable to all the manufacturing processes of drug preparations and to the key manufacturing processes of raw materials which may cause variation in the quality of finished products.第二条本规范是药品生产和质量管理的基本准则。

适用于药品制剂生产的全过程、原料药生产中影响成品质量的关键工序。

Chapter 2: Organization and PersonnelArticle 3: A pharmaceutical enterprise shall establish production and quality control departments. The responsibilities of departments at all levels and personnel shall be clarified, and each department shall be staffed by an appropriate number of management and technical personnel with expert knowledge, manufacturing experience and organization ability. 第三条药品生产企业应建立生产和质量管理机构。

制药验证文件-洁净空压机验证方案(英文版)

Qualification Protocol for New Air Compressor (COMP04)1. Short Description of Project / Facility / System1.1 Project DescriptionAs part of the “Extension of Production Facility, ChangPing” Project (EPCP, No. CNPHCP200502), a new Air Compressor COMP04 will be installed in the existing utilities area for the complementary production of compressed air.For general information, reference is made to:EPCP_11_06_INFRA_URS (current version)●INFRA URS,EPCP_01_00_HLD_URS (current version)●Project URS,EPCP_01_00_HLD_QMP (current version)●Project Qualification Master Plan,EPCP_01_00_HLD_QNA (current version)●Qualification Need Assessment,●Functional Risk Assessment EPCP_11_03_CA_FRA_2.0EPCP - CR 0238●Change request (new compressor)1.2 Functional Description for the ZT compressor with IMD dryer.NB. For the complete functionality of the CA system refer to the functional specification EPCP_11_03_CA_FS in its current version.Air drawn in through air filter (AF) and the open inlet valve of the unloader assembly (UA) is compressed in the low-pressure compressor element (El) and discharged to the intercooler (Ci).The cooled air is further compressed in the high-pressure compressor element (Eh) and discharged through the pulsation damper (AS) and the after cooler (Ca).A check valve (CV) is provided downstream of the pulsation damper (AS).When the compressor switches to unload operation, the air trapped in the pulsation damper and the high-pressure element is blown off via the blow-off silencer (US).The check valve (CV) prevents compressed air downstream the check valve to be blown off.Flow diagramAF Air filter (1) IMD bypass valve M4 Gear motor, IMD AS Pulsation damper (2) IMD air inlet valve EWD ElectronicCV Check valve drain, inlet airUS Blow-off silencer (3) DemisterCa After cooler with integrated drain (4) Nozzle Car Regeneration air cooler, IMD collector (5) IMD outlet valve FN Fan, regeneration air IS Inlet silencer cooler to air outlet valve (customer’sUA Unloader assembly installation)EWDa Electronic drain, after cooler (6) Rotor, IMDOP Oil pump (7) Regulating valve regeneration airCi Intercooler with integrated drain collectorGC Oil sump (gear casing)EWDi Electronic drain, intercoolerCo Oil coolerEh High-pressure compressor elementOF Oil filterEl Low-pressure compressor elementFN1 Cooling fan (ZT)1.3 Main emphasis on quality critical issues1.3.1 GMP Risk AssessmentThe air compressor installation will be in compliance with the valid Project Qualification Master Plan, Doc. No. EPCP_01_00_HLD_QMP, EPCP_11_03_CA_FRA in their current version.1.3.2 Critical measurement instrumentsInstruments for : Operating pressure, Dew point and Temperature.1.3.3 Critical items/functionsSpecification for construction material of operational parts.Air drying process.1.3.4 Qualification strategyThe air compressor qualification is covered by the following documents:URS,GMP and Functional Risk AssessmentQualification Protocol (QP)DQ, IQ & OQQualification Report (QR).Notes:1. No separate CSV Qualification Protocol and Qualification Report are needed since itis a Class 4 system.2. A 21CFR Part 11 Risk Assessment is not requested because the control system is notable to store any data.3. The air compressor and its auxiliaries will be commissioned with the support of aVendor Engineer.5. T he Qualification (DQ/IQ/OQ) will be prepared by BNP’s own Engineers, based onthis QP. The Qualification Documentation will be prepared by Luwa.6. The calibration during IQ will be executed by the vendor technician supervised byBNP R&M engineers.7. The qualification strategy and tests scope will be based on the qualification of theexisting air compressor (same supplier, same type). No new GMP and Risk Assessment will be prepared.2. Steps covered in this ProtocolFor the Qualification of the air compressor, the present QP will be followed. The qualification documents for the air compressor will be created (DL and DQ, IQ, OQ) and will be filed with this qualification.NB: This Qualification plan does not include interfacing utilities. For information about the qualification of the CA system, see EPCP_11_03_CA_QP in its current version.Design Qualification (DQ): yes: no: NA: Commissioning (GEP) 1): yes: no: NA: Installations Qualification (IQ): yes: no: NA: Operational Qualification (OQ): yes: no: NA: Operational Qualification (PQ) 2): yes: no: NA:1) Only FAT and correct installation before IQ (SAT)2) PQ will be done by checking the Pressure and microbial test at the exhaust of the new air compressor. No water content testing will be made as the dryness and oil free status is certified by the manufacturer.Copies of the certificates will be filed in the qualification binder.3. Documentation3.1 Qualification Documents List (GPE_FRM_511_0071)Refer to “Qualification Document List for the air com pressor, EPCP_11_03_CA_COMP04_DL” in its current version.3.2 Project Specific SOP’sNo project specific SOPs for the commissioning execution of this new air compressor.3.3 Administration of DocumentsThe Documents are filed according to “Document Management Syst em:Doc. No EPCP_01_00_HLD_DMS” in its current version.4. Basics4.1 Basic SOP’sGPE_SOP_508_0484: Concept for Commissioning and QualificationEPCP-SOP-001: CommissioningGPE_SOP_511_0042: Specification, Execution and Deviation Resolution of TestsGPE_SOP_511_0030 Handling of Changes (Engineering Projects)4.2 Project Specific AgreementsTwo types of training activities will be conducted one training for qualification execution and an other training for operation and maintenance.Qualification execution training is mandatory for all persons taking part in the qualification work. The training will be conducted by Luwa, and each test person shall complete the training before the empowerment to execute qualification and commissioning activities. Operation and maintenance training will be conducted by the EPCP or the vendor. Luwa operators, engineers or technicians should complete the training based on the functional requirements.Luwa Persoamal Training Record (FRM_000037) and Training Record (FRM_000039) will be used to document the training.5. Qualification Activities (Action Plan)5.1 Project Time ScheduleRefer to project time schedule in its current version.5.2 Qualification Activities (included in Project Time Schedule)All qualification activities are summarized in “Section 1.3 Main emphasis on quality critical issues”, “Section 3.1 Qualification Documents List”.6. Organization / Responsibility6.1 Qualification OrganizationRefer to “Qualification Master Plan, EPCP_01_00_HLD_QMP” for responsibilities matrix. 6.2 Project OrganizationThe organization is within the current EPCP organization chart in PPM.7. Attachments to ProtocolAttachment 1 Qualification Document List for air new compressor,EPCP_11_03_CA_COMP04_DL in its current version.。

欧盟GMP附录15确认和验证中英文新版

欧盟GMP附录15确认和验证欧盟GMP附录15确认和验证ANNEX 15 附件15Qualification and Validation确认和验证Table of Contents 目录1. Qualification and Validation 确认和验证2. Planning for Validation 验证计划3. Documentation 文件4. Qualification 确认5. Process Validation 工艺验证6. Cleaning Validation 清洁验证7. Change Control 变更控制8. Revalidation 再验证9. Glossary 术语表Qualification and Validation 确认和验证Principle 原理1.This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.1.本附件描述了确认和验证的原理，适用于医药产品的生产者。

欧盟GMP中英文对照

欧盟G M P中英文对照(总66页)-CAL-FENGHAI.-(YICAI)-Company One1-CAL-本页仅作为文档封面，使用请直接删除European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS目录第一章质量管理CHAPTER 1: QUALITY MANAGEMENT原则............................................................ ............. ........................................ ............ ...................... ..5 Principle................................................................... ............................................................................ (5)质量保证................................................................... ...... ........ . (5)Quality Assurance................................................................... (5)药品生产质量管理规范(GMP)...................................................................... (7)Good Manufacturing Practice for Medicinal Products.................................................................... . (7)质量控制(QC) ...................................................................... . (9)QualityControl....................... ............................................. . (9)产品质量回顾....................... ....................... .......................... . (10)第二章人员CHAPTER 2: PERSONNEL................................................................... ................... .. (11)原则............................................................................ . (11)Principle................................................................... (11)通则............................................................................ . (12)General..................................................................... ................................................. . (12)关键人员.......................................................................... ......................................... . (12)Key Personnel................................................................... (12)培训.......................................................................... ............................................................................ . (12)Training.................................................................... ................................................. . (15)人员卫生.......................................................................... . (16)Personnel Hygiene..................................................................... .. (16)第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT................................................................ .. (18)原则.......................................................................... .. (18)Principle................................................................... .. (18)厂房.......................................................................... (18)Premises.................................................................... . (18)通则.......................................................................... (18)General..................................................................... .. (18)生产区.......................................................................... . (19)Production Area........................................................................ ................................................19贮存区.......................................................................... . (21)Storage Area........................................................................ .. (21)质量控制区.......................................................................... (22)Quality Control Area........................................................................ . (22)附助区.......................................................................... . (22)Ancillary Areas....................................................................... .. (22)设备.......................................................................... (23)Equipment................................................................... .. (23)第四章文件CHAPTER 4: DOCUMENTATION............................................................... . (24)原则.......................................................................... (24)Principle................................................................... .. (24)通则.......................................................................... (25)General..................................................................... .. (25)文件要求.......................................................................... (27)Documents Required.................................................................... (27)Specifications.............................................................. (27)Specifications for starting and packaging materials (27)Specifications for Intermediate and Bulk Products (27)Specifications for Finished Products.................................................................... (28)Manufacturing Formulae and Processing Instructions (28)Packaging Instructions................................................................ .. (30)Batch Processing Records..................................................................... . (31)Batch PackagingRecords. ................................................................... .. (32)Procedures and Records..................................................................... ................... .. (33)Receipt..................................................................... . (34)Sampling.................................................................... .. (34)Testing..................................................................... . (35)Other....................................................................... .. (35)第五章生产CHAPTER 5: PRODUCTION......................................... ........ (36)原则........................................ . (36)Principle (36)通则........................................ . (36)General (36)生产过程中对交叉污染的预防 (39)Prevention of Cross-contamination in Production (39)验证........................................ . (40)Validation................................. . (40)原料........................................ . (41)Starting Materials..................... . (41)生产操作：中间产品和待包装产品 (42)Processing Operations: Intermediate and Bulk Products (42)Packaging Materials.......................... . (43)包装操作........................................ . (44)Packaging Operations........................ . (44)成品........................................ . (46)Finished Products..................... . (46)不合格、回收料和退货物料 (46)Rejected, Recovered and Returned Materials (46)第六章质量控制CHAPTER 6: QUALITY CONTROL (48)原则........................................ . (48)Principle................................... . (48)通则........................................ . (48)General... .. (48)质量控制实验室规范 (49)Good Quality Control Laboratory Practice (49)Documentation (49)Sampling................................... (50)Testing... .. (52)销售产品的稳定性考察 (54)第七章委托生产与委托检验CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS (55)原则........................................ . (55)Principle................................... . (55)通则........................................ . (56)General..................................... . (56)委托方.................................... . (56)The Contract Giver.................... .. (56)受托方.................................... (57)The Contract Acceptor.............. (57)合同........................................ . (58)The Contract............................. (58)第八章投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (59)原则........................................ . (59)Principle.................................... . (59)Complaints................................ . (59)召回 (60)Recalls (60)第九章自查CHAPTER 9: SELF INSPECTION (61)原则 (61)Principle (61)附件8 原辅料和包装材料的取样ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS (63)原则 (63)Principle (63)人员 (63)Personnel (63)原辅料 (63)Starting materials (64)包装材料 (65)Packaging material (65)第一章质量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的，符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患者带来风险。

FDA-GMP中英文对照标准版

DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents 目录1. INTRODUCTION1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

洁净厂房及空调验证报告(模板)

XXXXXX有限公司验证报告编号：VD-001洁净厂房及空调验证方案起草人：检验员日期：审核人：质量部经理日期：批准人：质量部经理日期：目录1. 目的 (3)2. 描述 (3)2.1 确认背景及车间基本情况 (3)2.2 确认依据 (3)2.3 确认计划 (3)3. 范围 (3)4. 确认小组及职责 (4)5. 确认内容及标准 (4)5.1 安装再确认 (4)5.2 运行再确认 (9)5.3 性能再确认 (10)6. 确认结论 (10)7. 再确认周期 (10)8. 验证报告 (11)1. 目的对洁净厂房及空调进行确认，对其安装、运行、性能技术参数进行测试，确认厂房设施性能的可靠性。

确认洁净厂房及空调符合设计要求，符合医疗器械生产质量管理规范及YY0033-2000的要求，能满足产品的生产需要。

2. 描述2.1 再确认背景及车间基本情况本公司主要生产医用一次性口罩，洁净厂房由东莞市德长发净化设备有限公司设计、施工。

十万级洁净室面积1663.5m2，分别有更衣室、缓冲间、生产车间、內包间、洁具间、洗衣房、工位器具房等功能间，由空气净化系统对各功能间进行空气净化。

车间平面图见附件1。

纯化水采用二级反渗透制备，通过不锈钢304管道送至各使用水点。

排水采用不锈钢洁净地漏排放，避免污染。

动力管线穿越吊顶，采用硅胶密封。

围护结构、隔断和吊顶采用彩钢板，门、窗、墙角均采用优质铝合金材料。

联接处用圆弧型，易于清洁。

根据需要，有关功能间装有微压差计和温湿度仪，便于日常运行监控。

2.2 再确认依据2.2.1 GB 50243 通风与空调施工及验收规范2.2.2 GB 50073 洁净厂房设计规范2.2.3 GB 50457 医药工业洁净厂房设计规范2.2.4 GB 50591 洁净室施工及验收规范2.2.5 YY 0033 无菌医疗器具生产管理规范2.2.6 GB/T 16292 医药工业洁净室（区）悬浮粒子的测试方法2.2.7 GB/T 16293 医药工业洁净室（区）浮游菌的测试方法2.2.8 GB/T 16294 医药工业洁净室（区）沉降菌的测试方法2.2.9 医疗器械生产质量管理规范2.3 确认计划2020年03月01日至2020年03月23日3. 范围洁净厂房及有关设施。

洁净厂房和设施验证报告(模板)

洁净厂房和设施验证报告企业名称：文件编号：版本号：1、验证方案的起草、审核和批准：2、验证组成人员：洁净厂房和设施验证方案目录一、概述1. 验证范围和目的2. 验证背景3. 验证计划4. 验证方案二、安装确认三、空调系统运行确认四、空调系统净化性能确认五、日常监控与再验证六、验证结论及最终批准七、附件洁净厂房和设施验证报告一、概述1. 验证范围和目的：1.1范围：十万级净化厂房，公用工程系统及空调系统，通过连续三次对洁净区空气净化程度的测试，验证该厂房净化系统是否达到规定标准并具有稳定性和可重现性，具体步骤见验证报告。

1.2目的：1.2.1检查并确认十万级净化厂房符合设计要求，所需资料和文件符合《医疗器械生产质量管理规范》（下称《规范》）管理要求。

本验证方案只对其进行一般的检查确认，以消除其对空气净化验证过程的影响。

1.2.2检查并确认十万级净化厂房的空调净化系统的空气净化能力符合设计要求，净化系统具有稳定性，净化结果具有重现性。

通过对空调净化系统的验证，为洁净区符合生产工艺要求提供保证。

1.2.3检查并确认十万级净化的公用工程系统安装符合设计要求。

本验证方案只对其进行一般的检查确认，以消除其对空气净化验证过程的影响。

1.2.4评价验证结果并作出相应结论。

2. 验证背景：2.1车间简介：净化车间位于厂区xx侧，占地总面积xxxx㎡，分为一般生产区和十万级洁净区，承担着无菌医疗器械的生产任务。

2.2公用系统简介净化车间按照《规范》要求，拥有一套完整的公用系统，为无菌医疗器械的生产提供动力。

包括独立的电气控制系统、压缩空气系统、排污系统、水系统。

其中纯化水系统采用闭路循环方式供水，每个用水点由送水和回水管道组成，且管路中无盲点和死角。

在洁净区的每个用水点均设置了取样口，系统的总送水口和总回水口也设置了单独的取样口，水质检测严格按SOP有关文件执行。

压缩空气使用前经过过滤处理。

2.3空调系统：净化车间有独立的中央空调系统，用于洁净区新鲜空气的补充，以及空气的净化，温湿度调节和维持不同洁净区间压差，该系统由空气处理机组、空气输送设备及空气分布装置构成。

新版GMP厂房验证资料

********-2011-05****车间生产厂房再验证方案部门：****车间目录一、引言1．概述2．验证目的3. 验证实施进度4. 所用计量仪器5. 验证小组人员名单6.相关文件二、人员培训三、车间的平面布置1.车间平面布局图2.布局说明四、车间厂房建筑确认五、车间厂房设施的检查确认1．厂房水、电、工艺管道的检查2．照明设施检查3．安全设施检查六、称量间的设计确认七、厂房基本参数测试1.照明度测试2.噪声测试3.厂房密封性测试一、引言1．概述用于原料药的生产制备以及中试，生产车间的厂房是2009年按照GMP要求设计建设的，一共两层，建筑总面积为2600 m2。

一楼为普通品种生产线，其洁净区面积为232 m2，为D级；二楼为抗肿瘤生产线，其洁净区面积为228m2，也为D级。

每层楼有两条生产线，一个为中试生产线，一个为小试生产线。

一般生产区主要为合成、包装、动力及其他辅助区域。

第一部分是引言，主要是对整个方案的介绍，以便于更好地理解和实施方案。

第二部分是人员培训情况的描述。

第三部分车间的平面布置情况。

第四部分车间厂房建筑确认，主要是对地坪、吊顶、墙面、门窗、隔断情况等的确认。

第五部分车间厂房设施的检查确认，包括厂房水、电、工艺管道的检查，照明设施检查，安全设施检查。

第六部分是称量间的设计确认。

第七部分是厂房基本参数的测试，主要对厂房各房间的照明度、噪声、温湿度等基本参数的测试。

2．验证目的检查并确认生产车间厂房建筑、生产设施、照明设施运行一年后能否符合GMP要求，能适用于原料药药品的生产。

3.验证实施进度：2011年08月开始进行。

4.所用计量仪器5.验证小组成员名单：1.生产操作人员及检验人员，评价其培训情况是否符合GMP及操作的要求，培训文件如下：2.标准：上岗操作人员已经接受了相关的知识及操作技术培训，并经考核合格。

三、车间的平面布置1.车间平面布局图（见附图）2.布局说明。

2.1生产区有足够的平面和空间。

某公司已过新版GMP认证洁净厂房验证模版(中英文)汇总

Installation Qualification Protocol洁净室安装确认方案System No. 系统编号: CLR-01Index 目录1.PURPOSE目的 (3)2.SCOPE范围 (3)3.RESPONSIBILITY职责 (3)4.REGULATION AND GUIDANCE 法规和指南 (3)5.ABBREVIATIONS缩略语 (3)6.SYSTEM DESCRIPTION 系统描述 (3)7.GOOD DOCUMENTATION PRACTICE文件管理规范 (5)8.TEST LIST测试列表 (6)9.PERSONNEL IDENTIFICATION人员确认 (6)10.PROCEDURE过程 (7)10.1先决条件 (7)10.2文件确认 (10)10.3图确认 (11)10.4房间组件检查 (13)10.5仪器仪表校验 (15)10.6洁净室建造装修检查 (17)10.7电器安装检查 (22)11. DEVIATION REPORT偏差报告 (28)1. Purpose目的本安装确认方案的目的是测试、检查和洁净室是按照相应设计要求和供应商的建议进行安装的。

安装确认的测试和检查的结果将按照该验证方案进行记录。

安装确认将确定直接影响系统的关键部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。

测试和检查的结果将按照该验证方案进行记录。

2. Scope范围本方案确定了***********公司口服固体项目车间的洁净室（位号：***********）的安装确认。

3. Responsibility职责4. Regulation and Guidance 法规和指南(SFDA) GMP 2010版中国药典2010版现行版ISPE指南5“调试和确认”洁净厂房设计规范GB13554-925. Abbreviations缩略语6. System Description 系统描述口服固体制剂的洁净室包括以下级别D级区对产品无影响的房间无需验证。

新版GMP验证文件(2010修订版)—洁净区厂房与设施验证方案(2012)

பைடு நூலகம்
xxxxxx 车间洁净区厂房与设施验证方案
编号：
8.1 厂房设计确认
8.1.1 厂房设计确认目的
在厂房设计确认中，通过对厂址选择、厂区总体布局和洁净区设计的确认厂房符合现行
GMP 和相关法律法规的要求。在厂房设计确认中，通常分为内审和送当地药监局审核，由
于我公司原料车间厂房为已通过药监局审核的已建厂房，此次确认前没有进行改造，因此
㎡。
厂区周围绿树成荫,无污染空气的源头存在,空气宜人。厂区东西两侧为主公路主公路属
于钢筋水泥路,不会产生很大的尘埃粒子,公路两侧栽有绿树。与 xxxxxx 车间平行的东侧为
绿化带，西面是本公司行政办公室与五金仓库。
2010 版 GMP 的实施后，我公司对 xxxxxx 车间部分厂房设施进行改造，发生变更。因
第 1 页共 11 页
Xxxxxxxx 公司
xxxxxx 车间洁净区厂房与设施验证方案
编号：
1 概述
xxxxxx 公司位于 xxxxxx，厂区占地面积平方米，建筑面积。厂区现有 2 个出入口，人
流入口靠厂区北侧，物流入口靠厂区的南侧。裸露土地均种植草皮，无花粉飞扬。xxxxxx
车间厂房位于厂区东部，用于生产 xxxxxx 甙产品。总面积为平方米，洁净区面积为 448
7 相关SOP及相关验证文件
7.1 相关 SOP 文件
文件名
文件编号
备注
确认与验证管理规程
厂房、设施确认管理规程
偏差管理规程
7.2 验证相关图纸
7.2.1 需要使用的图纸
序号
图纸名称
1
厂区周围环境图
2
厂区总平面布置图
3
厂区常年风向图

某公司已过新版GMP认证洁净厂房验证模版(中英文)

CleanRoomInstallationQualificationProtocol干净室安装确认方案SystemNo.系统编号:CLR-01Index名目1. Purpose目的本安装确认方案的目的是测试、检查和干净室是按照相应设计要求和需求商的建议进行安装的。

安装确认的测试和检查的结果将按照该验证方案进行记录。

安装确认将确定直截了当妨碍系统的要害部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。

测试和检查的结果将按照该验证方案进行记录。

2. Scope范围本方案确定了***********公司口服固体工程车间的干净室〔位号：***********〕的安装确认。

3. Responsibility职责4. RegulationandGuidance法规和指南(SFDA)GMP2021版中国药典2021版现行版ISPE指南5“调试和确认〞干净厂房设计标准GB13554-92 5. Abbreviations缩略语6. SystemDescription系统描述口服固体制剂的干净室包括以下级不D级区非要害生产步骤的干净区对产品无妨碍的房间无需验证。

7. GoodDocumentationPractice文件治理标准记录用笔：- 使用不消退的墨水笔和记号笔，推举使用蓝色笔记录签名：- 被授权的人员才能签署文件- 应签全名，除非文件另有规定- 签名应该是可识不的- 签名应始终一致填写栏目：- 所有栏目必须填写- 填写内容与上面栏目相同应重新填写- 假设有单个栏目不需要填进内容，那么在空白处填写英文字母“不适用〞的简写“N/A〞，以表示无此项内容。

- 填写记录时，假设有多个栏目不需要填进内容，应用歪线划掉，歪线上方填写“N/A，下方签名和注明日期。

签名及日期应尽量沿歪线同侧填写。

文件刚完成，马上更改的在错误处划线，填进正确的，签名和注明更改日期，确保原先信息仍清楚可识不如：2010年01月01日签字，日期事后更改的，除非马上更改的要求外，还应注明更改的缘故，检查和注释可能的妨碍。

q7A-GMP中英文对照

Q7a （中英文对照）FDA 原料药GMP 指南Table of Contents 目录1. INTRODUCTION 1. 简介1.1 Objective 1.1目的1.2 Regulatory Applicability 1.2法规的适用性1.3 Scope 1.3范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1总则2.2 Responsibilities of the Quality Unit(s) 2.2质量部门的责任2.3 Responsibility for Production Activities 2.3生产作业的职责2.4 Internal Audits (Self Inspection) 2.4内部审计（自检）2.5 Product Quality Review 2.5产品质量审核3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.人员的资质3.2 Personnel Hygiene 3.2 人员卫生3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施4.1 Design and Construction 4.1 设计和结构4.2 Utilities 4.2 公用设施4.3 Water 4.3 水4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 排污和垃圾4.7 Sanitation and Maintenance 4.7 卫生和保养5. PROCESS EQUIPMENT 5. 工艺设备5.1 Design and Construction 5.1 设计和结构5.2 Equipment Maintenance and Cleaning 5.2 设备保养和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录6.1 Documentation System and Specifications6.1 文件系统和质量标准 6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials6.3 原料、中间体、原料药的标签和包装材料的记录 6.4 Master Production Instructions (Master Production and Control Records)6.4 生产工艺规程（主生产和控制记录） 6.5 Batch Production Records (Batch Production and Control Records) 6.5 批生产记录（批生产和控制记录）6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7批生产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 控制通则7.2 Receipt and Quarantine 7.2接收和待验7.3 进厂物料的取样与测试7.3 Sampling and Testing of IncomingProduction Materials7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. 生产和过程控制8. PRODUCTION AND IN-PROCESSCONTROLS8.1 Production Operations 8.1 生产操作8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 工序取样和控制8.4 中间体或原料药的混批8.4 Blending Batches of Intermediates orAPIs8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATION9. 原料药和中间体的包装和贴签 LABELING OF APIs ANDINTERMEDIATES9.1 General 9.1 总则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与控制9.4 Packaging and Labeling Operations 9.4 包装和贴签操作10. STORAGE AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 入库程序10.2 Distribution Procedures 10.2 分发程序11. LABORATORY CONTROLS 11.实验室控制11.1 General Controls 11.1 控制通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的测试 11.3 Validation of Analytical Procedures 11.3 分析方法的验证11.4 Certificates of Analysis 11.4 分析报告单11.5 Stability Monitoring of APIs 11.5 原料药的稳定性监测11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. V ALIDATION 12.验证12.1 Validation Policy 12.1 验证方针12.2 Validation Documentation 12.2 验证文件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4 工艺验证的方法12.5 Process Validation Program 12.5 工艺验证的程序12.6 Periodic Review of Validated Systems 12.6验证系统的定期审核12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析方法的验证13. CHANGE CONTROL 13.变更的控制14. REJECTION AND RE-USE OF14.拒收和物料的再利用 MATERIALS14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 返工14.3 Reworking 14.3 重新加工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS17.代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 17.1适用性17.2 Traceability of Distributed APIs and Intermediates17.2已分发的原料药和中间体的可追溯性 17.3 Quality Management 17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5稳定性17.6 Transfer of Information 17.6 信息的传达17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18. 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and Record Keeping18.2细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 18.4收取、分离和精制18.5 Viral Removal/Inactivation steps18.5 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials19. 用于临床研究的原料药 19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production 19.5 生产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 文件20. Glossary 20 . 术语Q7a GMP Guidance for APIsQ7a 原料药的GMP 指南1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and puritycharacteristics that they purport, or arerepresented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP ）提供指南。

GMP认证文件偏差中英文

STANDARD OPERATING PROCEDURE 标准操作规程Title : QUALITY DEVIATION MANAGEMENT 题目：质量偏差管理Procedure:编号:Effective Date:生效日期:Supersedes:替代:Review Date:复审日期：Unmodified Review History:Affected Department / Area :受影响的部门/ 区域:1.PURPOSE 目的Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken当产品、物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时，必须进行适当的调查，查明原因并采取必要的改正措施。

2.SCOPE 范围This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them.本SOP适用于处理所有失误及非计划性故障事件，含概用于产品并控制产品的化学成分、包装材料、药品、工艺、系统、设备、公共设施和厂房等。

洁净厂房再验证报告

***厂房再验证报告
目录
一、概述
二、验证内容
三、再验证周期
四、验证结果与评价
五、最终结论
一、概述
***车间位于本公司的**厂房内，用于生产***，总面积为**平方米。

其中**平方米用于*****等，属于10000级洁净区， **平方米用于脱外衣换鞋，属于100000级。

1.验证目的：检查并确认***厂房经过几年的使用和运行后，仍符合GMP的管理要求及公司生产使用要求。

2.范围：适用于****厂房的验证。

3.责任：*****负责此验证方案的实施。

4.确认所需的文件
二、验证内容
1.结构及设施确认：
2.工艺布局确认
3照明系统安装测试与确认3.1 安装确认
3.2照度测定确认
使用仪器为
照度测试结果详见“生产洁净区（室）照度测试记录”。

各房间照度测定
4.卫生设施的确认
三再验证
1 再验证每年进行一次
2 结构如有重大改变，应相应进行验证。

四验证结果与评价：综合所有验证资料，整理验证结果，填写“再验证结果评价和建议”并呈报验证小组进行会签。

五、最终结论：
验证小组对验证结果进行综合评审，做出验证结论，并发放“再验证合格证书”。

样板检验报告(中英文版)

电镀,喷粉等表面自理良好
□
Visible
目视
⑵No bur or crack,good surface polishing
无批锋,毛刺,裂良等现象,表面光滑
□
⑶No surface shrinkage,bubble or scrape mark
表面无任何缩水,起泡,刮伤等不良
□
⑷Others
其它
□
Assembly
□
⑷No oversight with fixture assembly
无漏装零件
□
⑸Other:
其它
□
Functional
功能
⑴LED w/o function,INT orpower doesn’t off
灯无不亮,INT,灯不灭现象
□
50W sun light(50W日光灯)
⑵Plating,spraying pass adhesion testing(D3359-02)
电镀,喷粉通过D3359-02测试
□
Measurement meter(测试表)
Constant temp. & humidity case
(恒温恒湿箱)
⑶Others
其它
□
Packing
包装
⑴No oversight with fixture assembly
无漏装零件
□
Dropping test equipment
样板数量:
Checking Quantity:
检查数量:
Review Content(检查内容)
Appearance
外观
Sample Requirement

EUGMP-中英文对照[2]

EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS （中英文对照）(a) These are average values. （一）这些都是平均值。

(b) Individual settle plates may be exposed for less than 4 hours. （二）单个沉降皿放置的时间可以少于4小时。

20. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action。

对尘埃粒子和微生物的监控结果，要设置适当的警戒限度和行动限度。

当超出这些限度时，操作规程应说明需要采取的措施。

Isolator technology 隔离技术21. The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment. There are many possible designs of isolators and transfer devices. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from a single door to double door designs to fully sealed systems 在生产区采用人员方面的隔离技术，在无菌产品的生产中，会显著降低周围环境微生物污染的风险。