精品Attachment for GMP index
GMP手册范本
GMP手册范本GMP手册范本：1、引言1.1 目的和范围1.2 定义1.3 参考文件1.4 缩略词和缩写2、质量管理体系2.1 组织结构2.2 责任分配2.3 人员资质和培训2.4 文件控制2.5 内部审核2.6 不合格品处理2.7 改进体系3、设备管理3.1 设备验证和校准3.2 设备维护3.3 记录和文档管理4、原料和物料管理4.1 原料的采购控制4.2 原料接收和质检4.3 原料存储和保管4.4 原料标识和追溯性5、生产管理5.1 生产计划和排程5.2 工艺指导书5.3 生产记录和批记录 5.4 工艺变更管理5.5 中止生产和召回控制6、检验和测试6.1 检测设备和方法验证 6.2 检验和测试计划6.3 样品处理和存储6.4 检验和测试结果处理6.5 报告和报表记录7、追溯性和回溯性有效性管理 7.1 产品标识和追溯性7.2 产品回溯性和批记录7.3 客户投诉处理7.4 不良事件处理8、条件监测和环境管理8.1 温湿度和洁净度控制8.2 检测和记录条件8.3 环境监测设备和方法验证8.4 环境相关修复控制9、供应商管理9.1 供应商评价和选择9.2 供应商审核9.3 供应商持续监控9.4 供应商不合格品处理10、文档和记录管理10.1 文档编制和订阅10.2 文档审查和变更控制 10.3 记录管理10.4 审计和合规性评估11、培训和意识11.1 培训计划和落实11.2 员工培训记录11.3 质量意识和参与12、废弃物管理12.1 废弃物分类和处理12.2 废弃物监控和记录13、法规合规性13.1 国内法规要求13.2 国际标准和法规要求 13.3 目标市场法规合规性附件1：质量管理组织结构图：：：法律名词及注释：- GMP：Good Manufacturing Practice，良好的生产规范，是一种确保药品和医疗器械在生产过程中，能够符合质量标准和规定的管理体系。
- 附件：指与主要文档相关的附属文件或记录，供参考或补充。
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。
原料药GMP规范指南中英文对照.doc
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 andSpecifications6.1 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 Materials 6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (MasterProduction and Control Records)6.4 生产工艺规程（主生产和控制记录）6.5 Batch Production Records (BatchProduction 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 Sampling and Testing of IncomingProduction Materials7.3 进厂物料的取样与测试7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. PRODUCTION AND IN-PROCESSCONTROLS8. 生产和过程控制8.1 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 Blending Batches of Intermediates orAPIs8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9. 原料药和中间体的包装和贴签9.1 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 OFMATERIALS14.拒收和物料的再利用14.1 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 RELABELLERS 17.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 andIntermediates17.2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 RecordKeeping18.2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 steps 18.5 病毒的去除/灭活步骤19.APIs for Use in Clinical Trials 19.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 APIs Q7a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 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。
EU GMP 指南附件8：起始物料和包装材料的取样(中英文)
EU GMP 指南附件8：起始物料和包装材料的取样（中英文）Annex 8 附件8SAMPLING OF STARTING AND PACKAGING MATERIALS起始物料和包装材料的取样Principle 原则Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on nonrepresentative samples. Correct sampling is thus an essential part of a system of Quality Assurance.取样是一个重要的操作，取样中，每批仅有小部分被取出。
如果对不具有代表性的样品进行检测，则不能得出有效结论。
因而正确的取样方法是质量保证体系的必要因素。
Note 注Sampling is dealt with in Chapter 6 of the Guide, items 6.11. to 6.14. This annex gives additional guidance on the sampling of starting and packaging materials.取样在指南第6章第6.11至6.14项。
本附件针对起始物料和包装物料给出一些额外的指南。
Personnel 人员1. Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include:取样人员应接受与正确取样操作相关的初始培训和周期性继续再培训，该培训应包括：—sampling plans,—取样计划—written sampling procedures,—书面取样程序—the techniques and equipment for sampling,—取样技术和取样工具—the risks of cross-contamination,—交叉污染风险—the precautions to be taken with regard to unstable and/or sterile substances,—对不稳定和/或无菌物料采取的预防措施—the importance of considering the visual appearance of materials, containers and labels,—考察物料、包材和标签的外观的重要性—the importance of recording any unexpected or unusual circumstances.—记录非预期或异常情况的重要性Starting materials 起始物料2. The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled.为保证起始物料一个完整批准的鉴别，一般需要对每个包装进行单独取样，独立检测鉴别项。
药用产品GMP指南第一部分翻译
vii. medicinal products are not sold or supplied before an authorised personhas certified that each production batch has been produced andcontrolled in accordance with the requirements of the marketingauthorisation and any other regulations relevant to the production,control and release of medicinal products;
药品生产质量管理规范是质量管理体系的一部分，保证按适合预期用途的质量标准及上市许可、临床试验许可或产品质量标准要求始终如一地生产及控制产品。药品生产质量管理规范涉及生产和质量控制。药品生产质量管理规范的基本要求是：
i. all manufacturing processes are clearly defined, systematically reviewedin the light of experience and shown to be capable of consistentlymanufacturing medicinal products of the required quality and complyingwith their specifications;
生产许可证持有人必须生产药品，从而确保药品适合预期用途、符合相应的上市许可证或临床试验许可证要求，不因为安全性问题、质量问题或有效性问题而把患者置于风险之中。实现上述质量目标是公司高级管理人员的职责，并要求公司的供应商、销售商，公司内所有各级员工与许多不同部门的员工共同参与、一起努力。要可靠地实现这一质量目标，必须综合设计一个整合药品生产质量管理规范（GMP）和质量控制、质量风险管理的制药质量保证体系并正确实施。质量体系应当全面文件化，并监察其有效性。整个制药质量体系应当配备充足的具有资质的人员，以及充分并适用的建筑物、设备和设施。生产许可证持有人以及质量受权人有额外的法律责任。
药品GMP认证检查指南(2019年完整版)共44页word资料
编者按：本资料是根据《药品GMP认证检查评定标准》（2019年版）与旧版《药品GMP认证检查指南》（通则和中药制剂）的相关内容，参考权威的培训资料精心整理而成，对于制药企业的药品GMP认证或自检等具有相当的参考价值。
当然，由于《药品GMP认证检查评定标准》（2019年版）刚实施不久，特别是对新增条款的理解需要一定的时间，难免有所欠缺，允许大家讨论的同时，敬请谅解。
——bill 于2019年4月药品GMP认证检查评定标准——2008年1月1日起施行一、药品GMP认证检查项目共259项，其中关键项目（条款号前加“*”）92项，一般项目167项。
二、药品GMP认证检查时，应根据申请认证的范围确定相应的检查项目,并进行全面检查和评定。
三、检查中发现不符合要求的项目统称为“缺陷项目”。
其中，关键项目不符合要求者称为“严重缺陷”，一般项目不符合要求者称为“一般缺陷”。
四、缺陷项目如果在申请认证的各剂型或产品中均存在，应按剂型或产品分别计算。
五、在检查过程中，企业隐瞒有关情况或提供虚假材料的，按严重缺陷处理。
检查组应调查取证并详细记录。
六、结果评定（一）未发现严重缺陷，且一般缺陷≤20%，能够立即改正的,企业必须立即改正；不能立即改正的,企业必须提供缺陷整改报告及整改计划，方可通过药品GMP认证。
（二）严重缺陷或一般缺陷>20%的，不予通过药品GMP认证。
药品GMP认证检查指南（2019年版）一、机构与人员【检查核心】药品生产和质量管理的组织机构对保证药品生产全过程受控至关重要；适当的组织机构及人员配备是保证药品质量的关键因素；人员的职责必须以文件形式明确规定；培训是实施药品GMP的重要环节。
1．检查企业的组织机构图，是否涵盖生产、质量、物料仓储、设备、销售及人员管理等内容，并有负责培训的职能部门/人员。
1．1组织机构图中是否能体现企业各部门的设置、隶属关系、职责范围及各部门之间的关系，其中生产和质量管理部门是否分别独立设置。
gmp法规 90条
gmp法规 90条The GMP (Good Manufacturing Practice) regulations, consisting of 90 guidelines, are a crucial set of standards that ensure the quality, safety, and efficacy of pharmaceutical products. These regulations play a vitalrole in the pharmaceutical industry by establishing a framework for manufacturing processes, quality control, and documentation. From various perspectives, it is evidentthat the GMP regulations are essential for protecting public health, maintaining product integrity, and fostering innovation in the pharmaceutical sector.From a public health standpoint, the GMP regulations are instrumental in safeguarding consumers. By enforcing stringent quality control measures, these regulations ensure that pharmaceutical products meet the required standards of safety, purity, and efficacy. This helps to prevent the distribution of substandard or counterfeit medications, which could have detrimental effects on patients' health. The GMP guidelines also address issuessuch as cross-contamination and proper storage conditions, reducing the risk of adverse reactions or ineffective treatments. Therefore, compliance with these regulations is crucial to protect the well-being of individuals relying on pharmaceutical products.Moreover, the GMP regulations contribute to product integrity and reliability. By establishing comprehensive documentation and record-keeping practices, theseguidelines enable traceability throughout the manufacturing process. This allows for the identification and correctionof any deviations or errors, ensuring that the finalproduct is of consistent quality. Additionally, the implementation of standardized manufacturing processeshelps to minimize variability, enhancing product uniformity and reducing the likelihood of batch failures. Consequently, adherence to the GMP regulations fosters trust and confidence in pharmaceutical products, both amonghealthcare professionals and patients.The GMP regulations also play a pivotal role infostering innovation within the pharmaceutical industry. Bysetting clear standards and expectations for manufacturing practices, these guidelines provide a level playing field for companies of all sizes. This encourages fair competition and incentivizes manufacturers to invest in research and development to improve their processes and products. Furthermore, the GMP regulations promote continuous improvement through regular inspections and audits, encouraging companies to stay up-to-date with advancements in technology and best practices. Ultimately, this drives innovation and the development of moreeffective and safer pharmaceutical products.It is important to note that compliance with the GMP regulations is not without its challenges. Pharmaceutical manufacturers face the constant pressure of balancing quality and cost-effectiveness. Adhering to the GMP guidelines often requires significant investments in infrastructure, equipment, and personnel training. Small and medium-sized enterprises may find it particularly challenging to meet these requirements, potentiallylimiting their ability to compete in the market. Therefore, it is crucial for regulatory authorities to provide supportand guidance to ensure that companies of all sizes can comply with the GMP regulations without compromising their viability.In conclusion, the GMP regulations comprising 90 guidelines are essential for ensuring the quality, safety, and efficacy of pharmaceutical products. From a public health perspective, these regulations protect consumers by preventing the distribution of substandard or counterfeit medications. They also contribute to product integrity and reliability through comprehensive documentation and standardized manufacturing processes. Additionally, the GMP regulations foster innovation within the pharmaceutical industry by providing a level playing field and encouraging continuous improvement. However, compliance with these regulations can be challenging, particularly for smaller companies. Therefore, it is crucial for regulatory authorities to provide support and guidance to ensure that all manufacturers can meet the GMP requirements, ultimately benefiting public health and promoting a thriving pharmaceutical sector.。
TGAGMP中英对照
TABLE OF CONTENT 目录CHAPTER 1 - QUALITY MANAGEMENT (1)Principle (1)Quality Assurance (1)Good Manufacturing Practice for Medicinal products (GMP) (2)Quality Control (3)Product Quality Review (4)Quality Risk Management (5)CHAPTER 2 - PERSONNEL (7)Principle (7)General (7)Key Personnel (7)Training (9)Personal Hygiene (9)CHAPTER 3 - PREMISES AND EQUIPMENT (11)Principle (11)Premises (11)General (11)Production Area (11)Storage Areas (13)Quality Control Areas (13)Ancillary Areas (14)Equipment (14)CHAPTER 4 - DOCUMENTA TION (15)Principle (15)General (15)Documents required (16)Specifications (16)Specifications for starting and packaging materials (16)Specifications for intermediate and bulk products (17)Specifications for finished products (17)Manufacturing Formula and Processing Instructions (17)Packaging Instructions (18)Batch Processing Records (18)Batch Packaging Records (19)Procedures and records (20)Receipt (20)Sampling (20)Testing (21)Other (21)CHAPTER 5 - PRODUCTION (22)Principle (22)General (22)Prevention of cross-contamination in production (23)V alidation (24)Starting materials (24)Processing operations - Intermediate and bulk products (25)Packaging materials (25)Packaging operations (26)Finished products (27)Rejected, recovered and returned materials (28)CHAPTER 6 - QUALITY CONTROL (29)Principle (29)General (29)Good Quality Control Laboratory Practice (30)Documentation (30)Sampling (30)Testing (31)On-going Stability Programme (32)CHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSIS (35)Principle (35)General (35)The Contract Giver (35)The Contract Acceptor (36)The Contract (36)CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL (38)Principle (38)Complaints (38)Recalls (39)CHAPTER 9 - SELF INSPECTION (40)Principle (40)CHAPTER 1 QUALITY MANAGEMENT质量管理PRINCIPLE 原则The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels wi thin the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s).制造商生产的药品必须能满足药品本身的潜在用途，符合市场的要求并且对使用者不存在药品安全、质量和疗效方面的危险。