FDA-GMP中英文对照标准版
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA
Table of Contents 目录
1. INTRODUCTION
1.1 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。它也着眼于帮助确保原料药符合其旨在达到或表明拥有的质量与纯度要求。
In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. An alternative approach may be used if such approach satisfies the requirements of the applicable statues. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.
本指南中所指的“制造”包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。本指南中，“应当”一词表示希望采用的建议，除非证明其不适用或者可用一种已证明有同等或更高质量保证水平的供选物来替代。本指南中的“现行优良生产管理规范（cGMP）”和“优良生产管理规范（GMP）”是等同的。
The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.
本指南在总体上未涉及生产人员的安全问题，亦不包括环保方面的内容。这方面的管理是生产者固有的责任，也是国家法律规定的。
This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial requirements. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents should be met.
本指南未规定注册/归档的要求、或修改药典的要求。本指南不影响负责药政审理部门在原料药上市/制造授权或药品申请方面建立特定注册/归档要求的能力。注册/归档的所有承诺必须做到。
1.2 Regulatory Applicability 1.2法规的适用性
Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance.
在世界范围内对原料药的法定定义是各不相同的。当某种物料在其制造或用于药品的地区或国家被称为原料药，就应该按照本指南进行生产。
1.3 Scope 1.3范围
This guidance applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile.
The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities.
本文件适用于人用药品（医疗用品）所含原料药的生产。它适用于无菌原料药在灭菌前的步骤。本指南不包括无菌原料药的消毒和灭菌工艺，但是，应当符合地方当局所规定的药品（医疗用品）生产的GMP指南。
This guidance covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination of these processes. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section 18.本文件适用于通过化学合成、提取、细胞培养/发酵，通过从自然资源回收，或通过这些工艺的结合而得到的原料药。通过细胞培养/发酵生产的原料药的特殊指南则在第18章论述。
This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this guidance. In addition, the guidance does not apply to medical gases, bulk-packaged drug (medicinal) products (e.g., tablets or capsules in bulk containers), or radiopharmaceuticals.
本指南不包括所有疫苗、完整细胞、全血和血浆、全血和血浆的衍生物（血浆成分）和基因治疗的原料药。但是却包括以血或血浆为原材料生产的原料药。值得注意的是细胞培养基（哺乳动物、植物、昆虫或微生物的细胞、组织或动物源包括转基因动物）和前期生产可能应遵循GMP规范，但不包括在本指南之内。另外，本指南不适用于医用气体、散装的制剂药（例如，散装的片剂和胶囊）和放射性药物的生产。
Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products).
第19章的指南只适用于用在药品（医疗用品）生产中的原料药制造，特别是临床实验用药（研究用医疗产品）的原料药制造。
An API starting material is a raw material, an intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API starting materials normally have defined chemical properties and structure.
“原料药的起始物料”是指一种原料、中间体或原料药，用来生产一种原料药，或者以主要结构单元的形式被结合进原料药结构中。原料药的起始物料可能是在市场上有售、能够通过合同或商业协议从一个或多个供应商处购得，或由生产厂家自制。原料药的起始物料一般来说有特定的化学特性和结构。
The company should designate and document the rationale for the point at which production of the API begins. For synthetic processes, this is known as the point at which API starting materials are entered into the process. For other processes (e.g., fermentation, extraction, purification), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the API starting material is normally introduced into the process.
生产厂商要指定并用书面文件说明原料药的生产从何处开始的理论依据。对于合成工艺而言，就是“原料药的起始物料”进入工艺的那一点。对其他工艺（如：发酵，提取，纯化等）可能需要具体问题具体对待。表1给出了原料药的起始物料从哪一点引入工艺过程的指导原则。
From this point on, appropriate GMP as defined in this guidance should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that steps as critical.
从这步开始，本指南中的有关GMP规范应当应用在这些中间体和/或原料药的制造中。这包括对原料药质量有影响的关键工艺步骤的验证。但是，值得注意的是厂商选择某一步骤进行验证，并不一定将该步骤定为关键步骤。
The guidance in this document would normally be applied to the steps shown in gray in Table 1. However, all steps shown may not be completed. The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps, purification, and packaging. Physical processing of APIs, such as granulation, coating or physical manipulation of particle size (e.g., milling, micronizing) should be conducted according to this guidance.
本文件的指南通常适用于表1中的灰色步骤。但在表中体现的所有步骤并不是将应用GMP管理的所有步骤全部体现出来了。原料药生产中的GMP要求应当随着工艺的进行，从原料药的前几步到最后几步，精制和包装，越来越严格。原料药的物理加工，如制粒、包衣或颗粒度的物理处理（例如制粉、微粉化）应当按本指南的标准进行。
This GMP guidance does not apply to steps prior to the introduction of the defined API starting material.
本GMP指南不适用于引入定义了的“原料药的起始物料”以前的步骤。
2. QUALITY MANAGEMENT 2．质量管理
2.1 Principles 2.1总则
2.10 Quality should be the responsibilities of all persons involved in manufacturing.
参与原料药生产的每一个人都应当对质量负责。
2.11 Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. 每一个生产商都应当建立并执行一套有管理人员和有关员工积极参与的有效的质量管理体系，并使其文件化。
2.12 The system for managing quality should encompass the organizational structure, procedures, process and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented.
质量管理体系应当包括组织机构、规程、工艺和资源，以及确保原料药会符合其预期的质量与纯度要求所必需的活动。所有涉及质量管理的活动都应当明确规定，并使其文件化。
2.13 There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. The quality unit can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization. 2.13 应当设立一个独立于生产部门的质量部门，同时履行质量保证(QA)和质量控制 (QC)的职责。依照组织机构的大小，可以是分开的QA和QC部门，或者只是一个人或小组。
2.14 The persons authorized to release intermediates and APIs should be specified.
2.14 应当指定授权发放中间体和原料药的人员。
2.15 All quality-related activities should be recorded at the time they are performed.
2.15 所有有关质量的活动应当在其执行时就记录。
2.16 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.
2.16 任何偏离既定规程的情况都应当有文字记录并加以解释。对于关键性偏差应当进行调查，并记录调查经过及其结果。
2.17 No materials should be released or used before the satisfactory completion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g., release under quarantine as described in Section 10 or the use of raw materials or intermediates pending completion of evaluation).
2.17 在质量部门对物料完成满意的评价之前，任何物料都不应当发放或使用，除非有合适的系统允许此类使用（如10.20条款所述的待检情况下的使用，或是原料或中间体在等待评价结束时的使用）。
2.18 Procedures should exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g., quality-related complaints, recalls, and regulatory actions).
2.18 应当有规程能确保公司的责任管理部门能及时得到有关药政检查、严重的GMP缺陷、产品缺陷及其相关活动（如质量投诉，召回，药政活动等）的通知。
2.2 Responsibilities of the Quality Unit(s) 2.2质量部门的责任
2.20 The quality unit(s) should be involved in all quality-related matters.
2.20 质量部门应当参与所有与质量有关的事物。
2.21 The quality unit(s) should review and approve all appropriate quality-related documents.
2.21 所有与质量有关的文件应当由质量部门审核批准。
2.22 The main responsibilities of the independent quality unit(s) should not be delegated. These responsibilities should be described in writing and should include, but not necessarily be limited to:
1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the manufacturing company
2. Establishing a system to release or reject raw materials, intermediates, packaging, and labeling materials
3. Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution
4. Making sure that critical deviations are investigated and resolved
5. Approving all specifications and master production instructions
6. Approving all procedures affecting the quality of intermediates or APIs
7. Making sure that internal audits (self-inspections) are performed
8. Approving intermediate and API contract manufacturers
9. Approving changes that potentially affect intermediate or API quality
10. Reviewing and approving validation protocols and reports
11. Making sure that quality-related complaints are investigated and resolved
12. Making sure that effective systems are used for maintaining and calibrating critical equipment
13. Making sure that materials are appropriately tested and the results are reported
14. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate
15. Performing product quality reviews (as defined in Section 2.5)
2.22 独立的质量部门的主要职责不应当委派给他人。这些责任应当以文字形式加以说明，而且应当包括，但不限于：
1. 所有原料药的放行与否。用于生产商控制范围以外的中间体的放行与否；
2. 建立一个放行与拒收原材料、中间体、包装材料和标签的系统；
3. 在供销售的原料药放行前，审核已完成的关键步骤的批生产记录和实验室检验记录；
4. 确保已对重大偏差进行了调查并已解决；
5. 批准所有的规格标准和主生产指令；
6. 批准所有可能影响原料药和中间体质量的规程；
7. 确保进行内部审计（自检）；
8. 批准中间体或原料药的委托生产商；
9. 批准可能影响到中间体或原料药质量的变更；
10. 审核并批准验证方案和报告；
11. 确保调查并解决质量问题的投诉；
12. 确保用有效的体系来维护和校验关键设备；
13. 确保物料都经过了适当的检验并报告结果；
14. 确保有稳定性数据支持中间体或原料药的复验期或有效期和储存条件；
15. 开展产品质量审核（详见2.5节）。
2.3 Responsibility for Production Activities 2.3生产作业的职责
The responsibility for production activities should be described in writing and should include, but not necessarily be limited to:
1. Preparing, reviewing, approving, and distributing the instructions for the production of intermediates or APIs according to written procedures
2. Producing APIs and, when appropriate, intermediates according to pre-approved instructions
3. Reviewing all production batch records and ensuring that these are completed and signed
4. Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded
5. Making sure that production facilities are clean and, when appropriate, disinfected
6. Making sure that the necessary calibrations are performed and records kept
7. Making sure that the premises and equipment are maintained and records kept
8. Making sure that validation protocols and reports are reviewed and approved
9. Evaluating proposed changes in product, process or equipment
10. Making sure that new and, when appropriate, modified facilities and equipment are qualified 生产作业的职责应当以文字形式加以说明，并应当包括，但不限于以下内容：
1. 按书面程序起草、审核、批准和分发中间体或原料药的生产指令；
2. 按照已批准的指令生产原料药或者中间体；
3. 审核所有的批生产记录确保其完整并有签名；
4. 确保所有的生产偏差都已报告、评价，对关键的偏差已做了调查，并记录结论；
5. 确保生产设施的清洁，必要时要消毒；
6. 确保进行必要的校验，并有记录；
7. 确保对厂房和设备进行保养，并有记录；
8. 确保验证方案和报告的审核与批准；
9. 对产品、工艺或设备拟作的变更进行评估；
10. 确保新的或已改进的生产设施和设备经过了确认。
2.4 Internal Audits (Self Inspection) 2.4内部审计（自检）
2.40 To verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule.
2.40 为确实符合原料药GMP原则，应当按照批准的计划进行定期的内部审计。
2.41 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.
2.41 审计结果及整改措施应当形成文件，并引起公司责任管理人员的重视。获准的整改措施应当及时、有效地完成。
2.5 Product Quality Review 2.5产品质量审核
2.50 Regular quality-reviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:
A review of critical in-process control and critical API test results
A review of all batches that failed to meet established specification(s)
A review of all critical deviations or nonconformances and related investigations
A review of any changes carried out to the processes or analytical methods
A review of results of the stability monitoring program
A review of all quality-related returns, complaints and recalls
A review of adequacy of corrective actions
2.50 原料药的定期质量审核应当以证实工艺的一致性为目的来进行。此种审核通常应当每年进行一次，并记录，内容至少应当包括：
关键工艺控制以及原料药关键测试结果的审核；
所有不符合既定质量标准的产品批号的审核；
所有关键的偏差或违规行为及有关调查的审核；
任何工艺或分析方法变动的审核；
稳定性监测的审核；
所有与质量有关的退货、投诉和召回的审核；
整改措施的适当性的审核。
2.51 The results of this review should be evaluated and an assessment made of whether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner.
应当对质量审核结果进行评估，并做出是否需要整改或做任何再验证的评价。此类整改措施的理由应当文件化。获准的整改措施应当及时、有效地完成。
3. PERSONNEL 3. 人员
3.1 Personnel Qualifications 3.1员工的资质
3.10 There should be an adequate number of personnel qualified by appropriate education, training, and/or experience to perform and supervise the manufacture of intermediates and APIs.
3.10 应当有足够数量的员工具备从事和监管原料药和中间体生产的教育、培训和/或经历等资格。
3.11 The responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be specified in writing.
3.11 参与原料药和中间体生产的所有人员的职责应当书面规定。
3.12 Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee’s functions. Records of training should be maintained. Training should be periodically assessed.
3.12 应当由有资格的人员定期进行培训，内容至少应当包括员工所从事的特定操作和与其职能有关的GMP。培训记录应当保存，并应当定期对培训进行评估。
3.2 Personnel Hygiene 3.2 员工的卫生
3.20 Personnel should practice good sanitation and health habits.
3.20 员工应当养成良好的卫生和健康习惯。
3.21 Personnel should wear clean clothing suitable for the manufacturing activity with which they are involved and this clothing should be changed, when appropriate. Additional protective apparel, such as head, face, hand, and arm coverings, should be worn, when necessary, to protect intermediates and APIs from contamination.
3.21 员工应当穿着适合其所从事生产操作的干净服装，必要时应当更换。其它保护性用品如头、脸、手和臂等遮护用品必要时也应当佩带，以免原料药和中间体受到污染。
3.22 Personnel should avoid direct contact with intermediates and APIs.
3.22 员工应当避免与中间体或原料药的直接接触。
3.23 Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated areas separate from the manufacturing areas.
3.23 吸烟、吃、喝、咀嚼及存放食品仅限于与生产区隔开的指定区域。
3.24 Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the condition could adversely affect the quality of the APIs until the condition is corrected or qualified medical personnel determine that the person’s inclusion would not jeopardize the safety or quality of the APIs.
3.24 患传染性疾病或身体表面有开放性创伤的员工不应当从事危及原料药质量的生产活动。在任何时候（经医学检验或监控检查）任何患有危及到原料药质量的疾病或创伤的人员都不应当参与作业，直到健康状况已恢复，或者有资格的医学人员确认该员工不会危及到原料药的安全性和质量。
3.3 Consultants 3.3 顾问
3.30 Consultants advising on the manufacture and control of intermediates or APIs should have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.
3.30 中间体或原料药生产和控制的顾问应当有足够的学历，受训和经验，能胜任所承担的工作。
3.31 Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants.
3.31 顾问的姓名、地址、资格和提供服务的类型都应当有文字记录。
4. BUILDINGS AND FACILITIES 4. 建筑和设施
4.1 Design and Construction 4.1 设计和结构
4.10 Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants, as appropriate.
4.10 用于中间体和原料药生产的厂房和设施的选址、设计和建造应当便于清洁，维护和适应一定类型和阶段的生产操作。设施的设计应尽量减少潜在的污染。如果中间体或原料药的生产有微生物限度要求，那么设施设计应相应的限制有害微生物的污染。
4.11 Buildings and facilities should have adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination.
4.11 厂房和设施应有足够空间，以便有秩序地放置设备和物料，防止混淆和污染。
4.12 Where the equipment itself (e.g., closed or contained system) provides adequate protection of the material, such equipment can be located outdoors.
4.12 自身能对物料提供足够保护的设备（如关闭的或封闭的系统），可以在户外放置。
4.13 The flow of materials and personnel through the building or facilities should be designed to prevent mix-ups and contamination.
4.13 通过厂房和设施的物流和人流的设计应当能防止混杂和污染。
4.14 There should be defined areas or other control systems for the following activities:
以下活动应当有指定区域或其它控制系统：
4.15 Adequate and clean washing and toilet facilities should be provided for personnel. These facilities should be equipped with hot and cold water, as appropriate, soap or detergent, air dryers, or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate. 4.15 应当为员工提供足够和清洁的盥洗设施。这些盥洗设施应当装有冷热水（视情况而定）、肥皂或洗涤剂，干手机和一次性毛巾。盥洗室应当与生产区隔离，但要便于达到。应当根据情况提供足够的淋浴和/或更衣设施。
4.16 Laboratory areas/operations should normally be separated from production areas. Some laboratory areas, in particular those used for in-process controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process, intermediate, or API.
4.16 实验室区域/操作通常应当与生产区隔离。有些实验室区域，特别是用于中间控制的，可以位于生产区内，只要生产工艺操作对实验室测量的准确性没有负面影响，而且，实验室及其操作对生产过程，或中间体，或原料药也没有负面影响。
4.2 Utilities 4.2 公用设施
4.20 All utilities that could affect product quality (e.g., steam, gas, compressed air, heating, ventilation, and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded. Drawings for these utility systems should be available.4.20 对产品质量会有影响的所有公用设施（如蒸汽，气体，压缩空气和加热，通风及空调）都应当确认合格，并进行适当监控，在超出
限度时应当采取相应措施。应当有这些公用设施的系统图。
4.21 Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These systems should be designed and constructed to minimize risks of contamination and cross-contamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture. Particular attention should be giving to areas where APIs are exposed to the environment.
4.21 应当根据情况，提供足够的通风、空气过滤和排气系统。这些系统应当根据相应的生产阶段，设计和建造成将污染和交叉污染降至最低限度，并包括控制气压、微生物（如果适用）、灰尘、湿度和温度的设备。特别值得注意的是原料药暴露的区域。
4.22 If air is recirculated to production areas, appropriate measures should be taken to control risks of contamination and cross-contamination.
4.22 如果空气再循环到生产区域，应当采取适当的控制污染和交叉污染的风险。
4.23 Permanently installed pipework should be appropriately identified. This can be accomplished by identifying individual lines, documentation, computer control system, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or ApI.
4.23 永久性安装的管道应当有适宜的标识。这可以通过标识每根管道、提供证明文件、计算机控制系统，或其它替代方法来达到。管道的安装处应当防止污染中间体或原料药。
4.24 Drains should be of adequate size and should be provided with an air break or a suitable device to prevent back-siphonage, when appropriate.
4.24 排水沟应当有足够的尺寸，而且应当根据情况装有空断器或适当的装置，防止倒虹吸。
4.3 Water 4.3 水
4.30 Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use. 4.30 原料药生产中使用的水应当证明适合于其预定的用途。
4.31 Unless otherwise justified, process water should, at a minimum, meet World Health Organization (WHO) guidelines for drinking (portable) water quality.
除非有其它理由，工艺用水最低限度应当符合世界卫生组织（WHO）的饮用水质量指南。
4.32 If drinking (portable) water is insufficient to ensure API quality and tighter chemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms, and/or endotoxins should be established.
4.32 如果饮用水不足以确保原料的质量，并要求更为严格的化学和/或微生物水质规格标准，应当指定合适的物理/化学特性、微生物总数、控制菌和/或内毒素的规格标准。
4.33 Where water used in the process is treated by the manufacturer to achieve a defined quality, the treatment process should be validated and monitored with appropriate action limits.
4.33 在工艺用水为达到规定质量由制造商进行处理时，处理工艺应当经过验证，并用合适的处置限度来监测。
4.34 Where the manufacturer of a nonsterile API either intends or claims that it is suitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms,
and endotoxins.
4.34 当非无菌原料药的制造商打算或者声称该原料药适用于进一步加工生产无菌药品（医疗用品）时，最终分离和精制阶段的用水应当进行微生物总数、致病菌和内毒素方面的监测和控制。
4.4 Containment 4.4 限制
4.40 Dedicated production areas, which can include facilities, air handling equipment and/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosprins.
4.40 在高致敏性物质，如青霉素或头孢菌素类的生产中，应当使用专用的生产区，包括设施、空气处理设备和/或工艺设备。
4.41 The use of dedicated production areas should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.
4.41 当涉及具有感染性、高药理活性或毒性的物料时（如，激素类或抗肿瘤类），也应当考虑专用的生产区，除非已建立并维持一套经验证的灭活和/或清洗程序。
4.42 Appropriate measures should be established and implemented to prevent cross-contamination from personnel and materials moving from one dedicated area to another. 4.42 应当建立并实施相应的措施，防止由于在各专用区域间流动的人员和物料而造成的交叉污染。
4.43 Any production activities (including weighing, milling, or packaging) of highly toxic nonpharmaceutical materials, such as herbicides and pesticides, should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic nonpharmaceutical materials should be separate from APIs.
4.43 剧毒的非药用物质，如除草剂、杀虫剂的任何生产活动（包括称重、研磨或包装）都不应当使用生产原料药所使用的厂房和/或设备。这类剧毒非药用物质的处理和储存都应当与原料药分开。
4.5 Lighting 4.5 照明
4.50 Adequate lighting should be provided in all areas to facilitate cleaning, maintenance, and proper operations.
4.50 所有区域都应当提供充足的照明，以便于清洗、保养或其它操作。
4.6 Sewage and Refuse 4.6 排污和垃圾
4.60 Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-products from manufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. Containers and/or pipes for waste material should be clearly identified.
4.60 进入和流出厂房及邻近区域的污水、垃圾和其它废物（如生产中的固态、液态或气态的副产物），应当安全、及时、卫生的处理。废物的容器和/或管道应当显著地标明。
4.7 Sanitation and Maintenance 4.7 卫生和保养
4.70 Buildings used in the manufacture of intermediates and APIs should be properly maintained and repaired and kept in a clean condition.
4.70 生产中间体和原料药的厂房应当适当地保养、维修并保持清洁。
4.71 Written procedures should be established assigning responsibility for sanitation and describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities.
4.71 应当制定书面程序来分配卫生工作的职责，并描述用于清洁厂房和设施的清洁的计划、方法、设备和材料。
4.72 When necessary, written procedures should be established for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents to prevent the contamination of equipment, raw materials, packaging/labeling materials, intermediates, and APIs.
.72 必要时，还应当对合适的灭鼠药、杀虫剂、杀真菌剂、烟熏剂和清洁消毒剂的使用制定书面程序，以避免对设备、原料、包装/标签、中间体和原料药的污染。
5. PROCESS EQUIPMENT 5. 工艺设备
5.1 Design and Construction 5.1 设计和结构
5.10 Equipment used in the manufacture of intermediates and APIs should be of appropriate design and adequate size, and suitably located for its intended use, cleaning, sanitation (where appropriate), and maintenance.
5.10 中间体和原料药生产中使用的设备应当有合理的设计和足够的尺寸，并且放置在适宜于其使用、清洁、消毒（根据情况而定）和保养的地方。
5.11 Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.
5.11 设备的构造中与原料、中间体或原料药接触的表面不会改变中间体和原料药的质量而使其不符合法定的或其他已规定的质量标准。
5.12 Production equipment should only be used within its qualified operating range.
5.12 生产设备应该只在其确认的操作范围内运行。
5.13 Major equipment (e.g., reactors, storage containers) and permanently installed processing lines used during the production of an intermediate or API should be appropriately identified.
5.13 中间体或原料药生产过程中使用的主要设备（如反应釜、贮存容器）和永久性安装的工艺管道，应当作适当的识别标志。
5.14 Any substances associated with the operation of equipment, such as lubricants, heating fluids or coolants, should not contact intermediates or APIs so as to alter the quality of APIs or intermediates beyond the official or other established specifications. Any deviations from this practice should be evaluated to ensure that there are no detrimental effects on the material’s fitness for use. Wherever possible, food grade lubricants and oils should be used.
5.14 设备运转所需的任何物质，如润滑剂、加热液或冷却剂，不应当与中间体或原料药接触，以免影响其质量，导致无法达到法定的或其它已规定的质量标准。任何违背该规定的情况都应当进行评估，以确保对该物质效果的适用性没有有害的影响。可能的话，应当使用食用级的润滑剂和油类。
5.15 Closed or contained equipment should be used whenever appropriate. Where open equipment is used, or equipment is opened, appropriate precautions should be taken to minimize the risk of contamination. 5.15 应当尽量使用关闭的或封闭的设备。若使用开放设备或设备被打开时，应当采取适当的预防措施，将污染的风险降至最小。
5.16 A set of current drawings should be maintained for equipment and critical installations (e.g.,
instrumentation and utility systems).
5.16 应当保存一套现在的设备和关键装置的图纸（如测试设备和公用系统）。
5.2 Equipment Maintenance and Cleaning 5.2 设备保养和清洁
5.20 Schedules and procedures (including assignment of responsibility) should be established for the preventative maintenance of equipment.
5.20 应当制订设备预防性保养的计划和程序（包括职责的分配）。
5.21 Written procedures should be established for cleaning equipment release for use in the manufacture of intermediates and APIs. Cleaning procedures should contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner. These procedures should include:
5.21 应当制订设备清洗及允许用于中间体和原料药生产的书面程序。清洁程序应当尽量详细，使操作者能对各类设备进行可重复的、有效的清洗。这些程序应当包括：
5.22 Equipment and utensils should be cleaned, stored, and, where appropriate, sanitized or sterilized to prevent contamination or carry-over of a material that would alter the quality of the intermediate or API beyond the official or other established specifications.
5.22 设备和用具应当清洁、存放，必要时还应进行消毒或灭菌，以防止污染或夹带物质影响中间体或原料药的质量导致其不符合法定的或其它已规定的质量标准。
5.23 Where equipment is assigned to continuous production or campaign production of successive batches of the same intermediate or API, equipment should be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants (e.g., degradants or objectionable levels of microorganisms).
5.23 若设备指定用于同一中间体或原料药的连续生产，或连续批号的集中生产，应当在适宜是时间间隔对设备进行清洗，以防污染物（如降解物或达到有害程度的微生物）的累积和夹带。
5.24 Nondedicated equipment should be cleaned between production of different materials to prevent cross-contamination.
5.24 非专用设备应当在生产不同物料之间作清洁，以防止交叉污染。
5.25 Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents should be defined and justified.
5.25 对残留物的可接受限量、清洗程序和清洁剂的选择应当规定并说明理由。
5.26 Equipment should be identified as to its contents and its cleanliness status by appropriate means. 5.26 设备内容物及其清洁状况应当用合适的方法标明。
5.3 Calibration 5.3 校验
5.30 Control, weighing, measuring, monitoring, and testing equipment critical for ensuring the quality of intermediates or APIs should be calibrated according to written procedures and an established schedule. 5.30 用于保证中间体或原料药质量的控制、称量、测量、监测和测试设备应当按照书面程序和规定的计划周期进行校验。
5.31 Equipment calibrations should be performed using standards traceable to certified standards, if they exist.
5.31 如果有的话，应当用可追溯到已检定的标准的标准来进行设备校验。
5.32 Records of these calibrations should be maintained. 5.32 校验记录应当加以保存。
5.33 The current calibration status of critical equipment should be known and verifiable.
5.33 应当知道并可证实关键设备的当前校验状态。
5.34 Instruments that do not meet calibration criteria should not be used.
5.34 不应当使用不符合校验标准的仪器。
5.35 Deviations from approved standards of calibration on critical instruments should be investigated to determine if these could have had an effect on the quality of the intermediates(s) or API(s) manufactured using this equipment since the last successful calibration.
5.35 应当调查关键仪器相对于合格校验标准的偏差，以便确定这些偏差对自上次成功校验以来，用该设备生产的中间体或原料药的质量是否有影响。
5.4 Computerized Systems 5.4 计算机控制系统
5.40 GMP-related computerized systems should be validated. The depth and scope of validation depends on the diversity, complexity, and criticality of the computerized application.
5.40 与GMP相关的计算机化系统应当验证。验证的深度和广度取决于计算机应用的差异性、复杂性和关键性。
5.41 Appropriate installation and operational qualifications should demonstrate the suitability of computer hardware and software to perform assigned tasks.
5.41 适当的安装确认和操作确认应当能证明计算机硬件和软件适合于执行指定的任务。
5.42 Commercially available software that has been qualified does not require the same level of testing. If an existing system was not validated at time of installation, a retrospective validation could be conducted if appropriate documentation is available.
5.42 经证明合格的商用软件不需要进行系统水平的检验。如果现行系统在安装时没有进行验证，有合适的文件证明时可进行回顾性验证。
5.43 Computerized system should have sufficient controls to prevent unauthorized access or changes to data. There should be controls to prevent omissions in data (e.g., system turned off and data not captured). There should be a record of any data change made, the previous entry, who made the change, and when the change was made.
5.43 计算机化系统应当有足够的控制，以防止未经许可存取或改动数据。应当有防止数据丢失（如系统关闭而数据未捕获）的控制。任何数据的变更、上一次输入、谁作的变更和什么时候变更都应当有记录。
5.44 Written procedures should be available for the operation and maintenance of computerized system.
5.44 应当有计算机化系统操作和维护的书面程序。
5.45 Where critical data are being entered manually, there should be an additional check on the accuracy of the entry. This can be done by a second operator or by the system itself.
5.45 手工输入关键性数据时，应当另外检查输入的准确性。这可由第二位操作人员或系统本身来进行。
5.46 Incidents related to computerized system that could affect the quality of intermediates or APIs or the
reliability of records or test results should be recorded and investigated.
5.46 应当加以记录可能影响中间体或原料药质量、或者记录或测试结果可靠性的与计算机化系统有关的偶发事件，并作调查。
5.47 Changes to computerized system should be made according to a change procedure and should be formally authorized, documented, and tested. Records should be kept of all changes, including modifications and enhancements made to the hardware, software, and any other critical component of the system. These records should demonstrate that the system is maintained in a validated state.
5.47 对计算机化系统所作的变更应当按照变更程序进行，并应当经过正式批准、记录成文并作测试。所有变更记录都应当保存，包括对系统的硬件、软件和任何其它关键组件的修改和升级。这些记录应当证明该系统维持在验证过的状态。
5.48 If system breakdowns or failures would result in the permanent loss of records, a back-up system should be provided. A means of ensuring data protection should be established for all computerized system.
5.48 如果计算机的故障或失效会导致记录的永久丢失，则应当提供备份系统。所有计算机化的系统都应当有数据保护措施。
5.49 Data can be recorded by a second means in addition to the computer system.
5.49 除计算机系统之外，数据可以用第二种方式记录。
6. DOCUMENTATION AND RECORDS 6. 文件和记录
6.1 Documentation System and Specifications 6.1 文件系统和质量标准
6.10 All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures. Such documents can be in paper or electronic form.
6.10 与中间体或原料药生产有关的所有文件都应当按照书面程序进行拟定、审核、批准和分发。这些文件可以是纸张或电子形式。
6.11 The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories.
6.11 所有文件的发放、修订、替换和收回应当通过保存修订历史来控制。
6.12 A procedure should be established for retaining all appropriate documents (e.g., development history reports, scale-up reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records). The retention periods for these documents should be specified.
6.12 应当制订一个保存所有适用文件（如开发历程报告、扩产报告、技术转移报告、工艺验证报告、培训记录、生产记录、控制记录和分发记录）的程序。应当规定这些文件的保存期。
6.13 All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.
6.13 所有生产、控制、销售记录都应保留至该批的有效期后至少一年。对于有复验期的原料药，记录应当保留至该批全部发出后三年。
6.14 When entries are made in records, these should be made indelibly in spaces provided for such entries, directly after performing the activities, and should identify the person making the entry. Corrections to entries should be dated and signed and leave the original entry still legible.
6.14 做记录时，应当在刚做操作活动后就在所提供的空白处以不易擦掉的方式填写，并标明填写者。修改记录时应当注明日期、签名并保持原来的记录仍可识读。
6.15 During the retention period, originals or copies of records should be readily available at the establishment where the activities described in such records occurred. Records that can be promptly retrieved from another location by electronic or other means are acceptable.
6.15 在保存期间，记录的原件或副本都应保留在记录中描述的活动发生的地方。能以电子或其它方式从另一地点即时恢复的记录也可以接受。
6.16 Specifications, instructions, procedures, and records can be retained either as originals or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques such as microfilming or electronic records are used, suitable retrieval equipment and a means to produce a hard copy should be readily available.
6.16 质量标准、指令、规程和记录保存方式可以是原件，或者真实的副本如影印本、缩微胶卷、缩微平片，或其它原始记录的准确复制件。在使用压缩技术如缩微胶卷或电子记录时，应当有适当的制备纸张副本的恢复设备和方法。
6.17 Specifications should be established and documented for raw materials, intermediates where necessary, APIs, and labeling and packaging materials. In addition, specifications may be appropriate for certain other materials, such as process aids, gaskets, or other materials used during the production of intermediates or APIs that could critically affect quality. Acceptance criteria should be established and documented for in-process controls.
6.17 应当制订原料、中间体（必要时）、原料药和标签及包装材料的质量标准。此外，应当为工艺助剂、垫圈，或中间体或原料药生产中使用的能决定性地影响质量的物料制订质量标准。中间控制应当制定可接受的标准，并成文备查。
6.18 If electronic signatures are used on documents, they should be authenticated and secure.6.18 如果文件采用电子签名，它们应当经过证实，并且确保其安全可靠。
6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录
6.20 Records of major equipment use, cleaning, sanitation, and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment and the person who performed the cleaning and maintenance.
6.20 主要设备的使用、清洁、消毒和/或灭菌和保养记录应当记有日期、时间（如有必要的话）、产品、设备中加工的每批批号以及进行清洁和保养的人。
6.21 If equipment is dedicated to manufacturing one intermediate or API, individual equipment records are not necessary if batches of intermediate or API follow in traceable sequence. In case where dedicated equipment is employed, the records of cleaning, maintenance, and use can be part of the batch record or maintained separately.
6.21 如果设备专门用于一种中间体或原料药的生产，而且该中间体或原料药的批号有可追溯性的顺序，那就不需要有单独的设备记录。专门设备的清洁、保养及使用记录可以作为批记录的一部分或单独保存。
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
6.30 Records should be maintained including:The name of the manufacturer, identity, and quantity of each shipment of each batch of raw materials, intermediates, or labeling and packaging materials for API’s; the name of the supplier; the supplier’s control number(s), if known, or other identification number; the number allocated on receipt; and the date of receipt
6.30 需保存的记录应当包括：每次到货的每批原料、中间体、原料药标签和包装材料的生产商的名称，标识和数量；供应商的名称、供应商的管理编号，或其它识别号码；物料接收编号和接收日期；
6.31 Master (approved) labels should be maintained for comparison to issued labels.
6.31 标准标签（已批准的）应当保留，用来与发放的标签作比较。
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）
6.40 To ensure uniformity from batch to batch, master production instructions for each intermediate and API should be prepared, dated, and signed by one person and independently checked, dated, and signed by
a person in the quality unit(s).
6.40 为确保批与批的一致性，每种中间体和原料药的生产工艺规程应当由一人拟定、注明日期并签名，并由质量部门的另一人独立进行检查、填写日期和签名。
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）
6.50 Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch production record should be checked before issuance to ensure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction. If the batch production record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used.
6.50 应当为每种中间体和原料药准备批生产记录，内容应当包括与各批生产和控制有关的完整资料。批记录发放之前，应当检查版本是否正确，是否是相应生产规程的准确明了的再现。如果批生产记录是按主文件的另一独立部分制定的，该文件应当包括对现行的生产工艺规程的参考。
6.51 These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the production code together with the date and time can serve as the unique identifier until the final number is allocated.
6.51 批记录在发放时应当有一个唯一的批号或标识号，有日期和签名。连续生产时，在最终批号确定前，可以将产品代码、日期和时间结合起来作为唯一的识别符。
6.53 Written procedures should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet specifications. The investigation should extend to other batches that may have been associated with the specific failure or deviation. 6.53 应当建立并执行一种书面程序，对在符合规格上有重大偏差或不合格的一批中间体或原料药进行调查。调查还应当延伸到与这批失误或偏差有关的其它批号。
6.6 Laboratory Control Records 6.6 实验室控制记录
6.60 Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays, as follows:
A description of samples received for testing, including the material name or source, batch number or other distinctive code, date sample was taken, and, where appropriate, the quantity and date the sample was received for testing
A statement of or reference to each test method used
A statement of the weight or measure of sample used for each test as described by the method; data on or cross-reference to the preparation and testing of reference standards, reagents and standard solutions
A complete record of all raw data generated during each test, in addition to graphs, charts and spectra from laboratory instrumentation, properly identified to show the specific material and batch tested
A record of all calculations performed in connection with the test, including, for example, units of measure, conversion factors, and equivalency factors
A statement of the test results and how they compare with established acceptance criteria
The signature of the person who performed each test and the date(s) the tests were performed
The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards 6.60 实验室控制记录应当包括从为了确保符合规定的规格和标准所做的所有测试中得到的下列完整的数据，包括下列检验和测定：所收到检测样品的描述，包括物料名称和来源、批号或其它编号、取样日期，某些情况下记录收到样品的量和时间；
每个所用检测方法的陈述或参引；
按方法描述的所用样品重量或计量；标准品、试剂和标准溶液的配制和测试的数据或相互参考；
除了正确地标明所测试的特定物料和批号的实验室仪器的图谱、图表和光谱外，还有一套从每次测试得到的所有原始数据的完整记录；
与测试有关的所有计算记录，包括测量单位、转换因子以及等量因子等；
检测结果的陈述以及与规定的认可标准的比较；
每项测试的操作者的签名以及测试的日期；
日期和第二个人的签名，表明对原记录的准确性、完整性和规定的标准的符合性已复核过。
6.7 Batch Production Record Review 6.7批生产记录审核
6.70 Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labeling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed.
6.70 应当制定并执行审核和批准批生产记录和实验室控制记录，包括包装和贴签的书面程序，以便放行或分发前确定中间体或原料药是否符合规定标准。
6.71 Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. Production and laboratory control records of noncritical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
6.71 在一批原料药放行或分发之前，关键工序的批生产记录和实验室控制记录应当由质量部门审核和批准。非关键性工序的生产和实验室控制记录可按照经质量部门批准的程序，由有资格的生产人员或其它部门审核。
6.72 All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released.
国内外著名大学校训(中英对照版)
校训乃一校之魂，原本是学校校长讲话中的关键词语，因为既有底蕴又有实效，所以被一代一代的教师和学子们传递下去，时间一长，就成了约定俗成的话语，这就是校训。校训，作为一个标尺，激励和劝勉在校的教师和学子们，即使是离开学校多年的人也会将校训时刻铭记在心。校训也能体现学校的办学原则与目标。同时它也是一种文化，是一种面向社会的精神标志，能为学校起到一定的宣传作用。有些校训还对其本校的创建历史或文化背景有所反映，包含着较多的信息。 大学不是单纯适应社会的产物，而是开启智慧、追求真理、传播知识、弘扬文化的重要场所，担当起引领社会发展方向的神圣使命。校训则是引领大学前进的方向标，良好的校训的确立，成为办好一所大学的先决条件。古今中外世界著名大学都各自拥有其独特的校训，鲜明的体现出他们不同的办学理念和治学特点。而由此形成的校训文化则成为大学教育中一道靓丽的风景。 东方和西方思想和思维有较大差异，由此导致东西方大学办学理念的不同，西方大学传统办学理念：合理求是、使命引导、学术自由、大学自治、积极应变、科学取向。东方大学传统办学理念：和而不同、各美其美、学术责任、与时俱进、止于至善、伦理（人文）取向。因而，体现办学理念的大学校训也就各有偏重。 美国斯坦福大学的校训是"让自由之风吹拂"，英国剑桥大学拉丁文校训引用的是苏格拉底的一句话"我与世界相遇，我自与世界相蚀，我自不辱使命，使我与众生相聚。"而中国科技大学的校训"红专并进理实交融"。 校训是一所大学学风的集中体现，实事求是，严谨务实，成为各高校培养高素质人才的首要准则。实事求是，意为：办事求学必须根据实证，求索真相，踏踏实实，知之为知之，不知为不知。追求真理，是治学最基本的目标，也是每一位求学者追求的崇高理想。世界著名学府哈佛大学的校训是：Let Plato be your friend, and Aristotle, but more let your friend be truth，中文翻译为"与柏拉图为友，与亚里士多德为友，更要与真理为友"。大学的目的不仅是让学生认识已有的知识，而且还要让他们去创新的知识。学生必须学会自己去认识真理。但追求新的真理并不是一帆风顺的，不仅需要付出艰辛的努力，而且可能遭到旧的威或当权者的反对。所以，与真理为友就显得更加可贵。耶鲁大学的校训也同为"光明与真理"。 “自强不息，厚德载物"中国高等学府清华大学的校训，也是当代大学生应该具备的优秀品质和基本道德素养。它精辟地概括了中国文化对人与自然、人与社会、人与人的关系的深刻认识与辩证的处理方法，是中华民族的民族精神与民族性格的重要表征。作为一个高尚的人，在气节、操守、品德、治学等方面都应不屈不挠，战胜自我，永远向上，力争在事业与品行两个方面都达到最高境界。 南开大学校训："允公允能日新月异"，提倡的是"公能"教育，一方面是培养青年"公而忘私"、"舍己为人"的道德观念；另一方面则是训练青年"文武双全"、"智勇兼备"，为国效劳的能力。这与美国普林斯顿大学的校训："普林斯顿——为了给国家服务"如出一辙。 大学校训有着深厚的文化底蕴，它可以体现出一个大学良好的精神风貌，优良的学风，先进的办学理念和教学方针政策，甚至是学校的整个文化背景和文化氛围。不同的国家、地区思想文化的差异，造成办学理念的差异，但这些理念不应是相互对立、互不通融的，而应该是相互交叉、相互补充。
国际贸易信用证样本中英文对照
信用证样本中英文对照 Issue of a Documentary Credit、BKCHCNBJA08ESESSION:000ISN:000000 BANK OF CHINA LIAONING NO.5ZHONGSHANSQUARE ZHONGSHANDISTRICT DALIAN CHINA-------开证行 Destination Bank通知行 : KOEXKRSEXXXMESSAGETYPE:700 KOREAEXCHANGEBANK SEOUL 178.2KA,ULCHIRO,CHUNG-KO--------通知行 Type of Documentary Credit 40A IRREVOCABLE--------信用证性质为不可撤消 Letter of Credit Number 20 LC84E0081/99------信用证号码,一般做单时都要求注此号 Date of Issue开证日期 31G 990916------开证日期 Date and Place of Expiry（失效日期和地点） 31D 991015KOREA-------失效时间地点 Applicant Bank开证行 51D BANK OF CHINA LIAONING BRANCH----开证行 Applicant开证申请人 50 DALIANWEIDATRADINGCO.,LTD.------开证申请人 Beneficiary受益人 59 SANGYONG CORPORATION CPOBOX110 SEOUL KOREA-------受益人 Currency Code,Amount信用证总额 32B USD1,146,725.04-------信用证总额 Availablewith...by... 41
螺丝,紧固件,标准件词汇的中英文对照
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信用证样本及翻译
信用证样本(1) Name of Issuing Bank The French Issuing Bank 38 rue Francois ler 75008 Paris, France To: The American Exporter Co. Inc. 17 Main Street Tampa, Florida Place and date of issue Paris, 1 January 2006 This Credit is advised through The American Advising Bank, 486 Commerce Avenue, Tampa, Florida Dear Sirs, By request of account of The French Importer Co. 89 rue du Comnerce Paris, France we hereby issue an Irrevocable Documentary Credit No. 12345 for USD 100,000 (say US Dollars one hundred thousand only) to expire on March 29, 2006 in American available with the American Advising Bank, Tampa by negotiation at sight against beneficiary's draft(s) drawn on The French Issuing Bank and the documents detailed herein: (1)Commercial Invoice, one original and three copies. (2)Multimodal Transport Document issued to the order of the French Importer Co. marked freight prepaid and notify XYZ Custom House Broker Inc. (3)Insurance Certificate covering the Institute Cargo Clauses and the Institute War and Strike Clauses for 110% of the invoice value blank endorsed. (4)Certificate of Origin evidence goods to be of U.S.A. Origin. (5)Packing List Evidencing transportation of Machines and spare parts as per pro-forma invoice number 657 dated January 3, 2006 from Tampa, Florida to Paris, France not late than March 15,2006- CIP INCOTERMS 1990. Partial shipment is allowed. Transshipment is allowed. Documents to be presented within 10 days after the date of the transport documents but within the validity of the credit. We hereby engage with drawers and/or bona fide holders that drafts drawn and negotiated in conformity with the terms of Credit will be fully honored on presentation. The number and the date of the Credit and the name of our bank must be quoted on all drafts required. Bank to bank instructions :… Yours faithfully The French Issuing Bank, Paris (signature)
信用证样本中英文对照1
跟单信用证：目前采用SWIFT格式，依据《UCP600》规定，例样如下： FROM：CITIBANK INTERNATIONAL，LOS ANGELES, U.S.A. 开证行：花旗银行美国洛杉矶 TO：BANK OF CHINA QINGDAO BRANCH，QINGDAO，CHINA 通知行：中国银行青岛分行中国青岛 :27: SEQUENCE OF TOTAL 1/1 :27: 电文序列、报文页次1/1 :40A: FORM OF DOCUMENTARY CREDIT IRREVOCABLE :40A: 跟单信用证格式不可撤销 :20: DOCUMENTARY CREDIT NUMBER CRED1523349 :20: 跟单信用证号CRED1523349 :3lC: DATE OF ISSUE 070906 :31C: 开证日期070906 :40E：APPLICABLE RULES UCP LATEST VERSION :40E: 适用规则《UCP》最新版本 :31D: DATE AND PLACE OF EXPIRY 071102 U.S.A. :31D: 有效期和有效地点071102 美国 :50: APPLICANT UNITED OVERSEAS TEXTILE CORP. 220E 8TH STREET A682 LOS ANGELES U.S.A. :50: 开证申请人美国大华纺织公司 220栋，8号街，682室 洛杉矶 美国 :59: BENEFICIARY QINGDAO QINGHAI CO.,LTD.
186 CHONGQIN ROAD QINGDAO 266002 CHINA :59: 受益人青岛青海有限公司 重庆路186号 中国青岛266002（邮编） :32B: CURRENCY CODE, AMOUNT: USD58575，00 :32B: 货币代码和金额58575.00美元 :39A：PRECENTAGE CREDIT AMOUNT TOLERANCE 10/10 :39A: 信用证金额上下浮动百分比10/10（10%） :41A: A V AILABLE WITH.. BY.. CITIUS33LAX BY DEFERRED PAYMENT :41A: 兑付方式花旗银行洛杉矶分行以延期付款方式兑付 :42P: DEFERRED PAYMENT DETAILS AT 90 DAYS AFTER B/L DATE :42P: 延期付款细节提单签发日后90天 :43P: PARTIAL SHIPMENTS NOT ALLOWED :43P: 分批装运不允许 :43T: TRANSSHIPMENT NOT ALLOWED :43T: 转运不允许 :44E: PORT OF LOADING/AIRPORT OF DEPARTURE QINGDAO PORT，CHINA :44E: 装运港/始发航空站中国青岛港 :44F: PORT OF DISCHARGE/AIRPORT OF DESTINATION LOS ANGELES PORT，U.S.A. :44F: 卸货港/目的航空站美国洛杉矶港 :44C: LATEST DATE OF SHIPMENT 071017 :44C: 最晚装运期071017 :45A: DESCRIPTION OF GOODS AND/OR SERVICES +TRADE TERMS: CIF LOS ANGELES PORT，U.S.A. ORIGIN:CHINA + 71000M OF 100% POLYESTER WOVEN DYED FABRIC
各种花的英文名
各种花卉的英文名 iris蝴蝶花 cockscomb鸡冠花 honeysuckle金银花chrysanthemum菊花 carnation康乃馨 orchid兰花 canna美人蕉 jasmine茉莉花 daffodil水仙花 peony牡丹 begonia秋海棠 cactus仙人掌 christmas flower圣诞花/一品红poppy罂粟 tulip郁金香 chinese rose月季 violet紫罗兰 peach flower桃花 aloe芦荟 mimosa含羞草 dandelion蒲公英
plum bolssom梅花中国水仙 new year lily 石榴 pomegranate 月桂victor's laurel 报春花 polyanthus 木棉 cotton tree 紫丁香 lilac 吊钟 lady's eardrops 紫荆 Chinese redbud 百合 lily 紫罗兰 wall flower 桃花 peach 紫藤 wisteria 杜鹃 azalea 铃兰 lily-of-the-valley 牡丹 tree peony 银杏 ginkgo 芍药 peony 蝴蝶兰 moth orchid 辛夷 violet magnolia 蟹爪仙人掌 Christmas cactus 玫瑰 rose 郁金香 tulip
茶花 common camellia 千日红 common globe-amaranth 非洲堇 African violet 栀子花 cape jasmine 木槿 rose of Sharon 风信子 hyacinth 百子莲 African lily 牵牛花 morning glory 君子兰 kefir lily 荷包花 lady's pocketbook 含笑花 banana shrub 非洲菊 African daisy 含羞草 sensitive plant 茉莉 Arabian jasmine 猪笼草 pitcher plant 凌霄花 creeper 树兰 orchid tree 康乃馨coronation 鸡冠花 cockscomb 荷花lotus 鸢萝 cypress vine 菩提 botree
螺丝名称的中英文对照表精选版
螺丝名称的中英文对照 表 Document serial number【KKGB-LBS98YT-BS8CB-BSUT-BST108】
螺丝名称的中英文对照表 常用英文单词及简写形式 No. 单词简写中文 1 screw scr 螺丝 2 nut nut 螺母 3 washer wash 垫圈 4 head hd 头 5 thread thre 螺纹 6 coating coat 镀层 7 rivet riv 铆钉 8 standoff stdoff 内外六角钉 9 driver driv 穴 10 hexagon hexa 六角 11 tooth tooth 齿 12 lock lck 锁 13 spring spr 弹簧 14 wave wave 波浪型 15 pitch pitch 牙距 16 partial thread P T 半螺纹 17 PT PT 一种螺纹形式 18 Full Thread FT 全螺纹 19 silver silv 银 20 cone cone 锥形 21 Eco-syn Eco 30度牙的一种螺纹 22 Thread Forming TF 自攻螺纹 23 Self Tapping self tapp 自切屑螺纹 24 pin pin 销 25 shaft Shaf 轴 26 steel St 铁 27 stainless steel SS 不锈钢 28 Brass(Cu) Bras(Cu) 铜 29 Aluminum AL 铝 30 Rubber Rub 橡胶 31 machine screw mech scr 机制螺丝 32 SEM screw SEM Scr 组合螺丝 33 Material material 材料 34 Grade GD 等级
常见信用证条款英汉对照翻译(DOC)
常见信用证条款英汉对照翻译 Business Documents国际商务单证 EDI （Electronic Date Interchange）电子数据交换 2000 INCOTERMS2000年国际贸易术语解释通则 UCP500Uniform Customs and Practice for Documentary Credit, ICC Publication No.500 跟单信用证统一惯例 CISGUnited Nations Convention on Contracts for the International Sale of Goods 联合国国际货物销售合同公约 Inquiry询价 Offer发盘 Counter Offer 还价 Acceptance接受 S/C Sales Confirmation 销售确认书（即合同） Physical Delivery实际交货 Symbolic Delivery象征性交货 FOBFree on Board装运港船上交货 CFRCost and Freight成本加运费 CIFCost Insurance and Freight成本加保险费和运费 FCAFree Carrier货交承运人 CPTCarriage Paid to运费付至 CIPCarriage and Insurance Paid to 运费、保险费付至 EXW工厂交货
FAS装运港船边交货 DAF边境交货 DES目的港船上交货 DEQ目的港码头交货 DDU未完税交货 DDP完税后交货 Commission佣金 Discount折扣 Remittance汇付 Remitter汇款人 Payee收款人 M/T Mail Transfer 信汇 T/T Telegraphic Transfer电汇 D/D Demand Draft票汇 Payment in Advance预付货款 Cash with Order随订单付款 Collection 跟单托收 Principal 委托人 Drawee 付款人 D/P Documents against Payment 付款交单 D/A Documents against Acceptance承兑交单D/P at sight 即期付款交单 D/P after sight远期付款交单 T/R Trust Receipt信托收据
信用证样本(中英文对照)
信用证样本(中英文对照) 信用证样本: 以下信用证内容源自华利陶瓷厂与一塞浦路斯客户所开立并顺利支付的信用证TO:BANK OF CYPRUS LTD LETTERS OF CREDIT DEPARTMENT NTCOSIA COMMERCIAL OPERATIONS CENTER INTERNATIONAL DIVISION ****** ****** TEL:****** FAX:****** TELEX:2451 & 4933 KYPRIA CY SWIFT:BCYPCY2N DA TE:23 MARCH 2005 APPLICATION FOR THE ISSUANCE OF A LETTER OF CREDIT SWIFT MT700 SENT TO:MT700转送至 STANDARD CHARTERD BANK UNIT 1-8 52/F SHUN NIND SQUARE O1 W ANG COMMERCIAL CENTRE,SHEN NAN ROAD EAST,SHENZHEN 518008 - CHINA 渣打银行深圳分行 深南东路5002号 信兴广场地王商业大厦52楼1-8单元 电话：82461688 :27: SEQUENCE OF TOTAL序列号 1/1 指只有一张电文 :40A: FORM OF DOCUMENTARY CREDIT跟单信用证形式IRREVOCABLE 不可撤消的信用证 :20OCUMENTARY CREDIT NUMBER信用证号码 00143-01-0053557 :31C: DATE OF ISSUE开证日 如果这项没有填，则开证日期为电文的发送日期。 :31DA TE AND PLACE OF EXPIRY信用证有效期 050622 IN CHINA 050622在中国到期 :50: APPLICANT 信用证开证审请人
植物花卉中英文对照
植物花卉中英文对照、花卉英文名大全 金橘－－－－－－－－－－－－－－kumquat 米仔兰(米兰）－－－－－－－－－ milan tree 变叶木－－－－－－－－－－－－－croton 一品红－－－－－－－－－－－－－poinsettia 扶桑－－－－－－－－－－－－－－Chinese hibiscus 吊灯花－－－－－－－－－－－－－fringed hibiscus 马拉巴栗（发财树)－－－－－－－ Guiana chestnut 山茶－－－－－－－－－－－－－－camellia 云南山茶－－－－－－－－－－－－Yunnan camellia 金花茶－－－－－－－－－－－－－golden camellia 瑞香－－－－－－－－－－－－－－daphne 结香－－－－－－－－－－－－－－paper bush 倒挂金钟－－－－－－－－－－－－fuchsia 八角金盘－－－－－－－－－－－－Japan fatsia 常春藤－－－－－－－－－－－－－ivy 鹅掌柴－－－－－－－－－－－－－umbrella tree 杜鹃花－－－－－－－－－－－－－rhododendron 茉莉花－－－－－－－－－－－－－jasmine 桂花－－－－－－－－－－－－－－sweet osmanthus 夹竹桃－－－－－－－－－－－－－sweet-scented oleander 黄花夹竹桃－－－－－－－－－－－lucky-nut-thevetia 鸡蛋花－－－－－－－－－－－－－frangipani 龙吐珠－－－－－－－－－－－－－bleeding-heart glorybower 夜香树（木本夜来香）－－－－－－night jasmine 鸳鸯茉莉－－－－－－－－－－－－broadleaf raintree 栀子花－－－－－－－－－－－－－cape jasmine 蝴蝶兰－－－－－－－－－－－－－moth orchid 卡特兰－－－－－－－－－－－－－cattleya 石斛－－－－－－－－－－－－－－dendrobium 兜兰－－－－－－－－－－－－－－lady slipper 兰花－－－－－－－－－－－－－－orchid 春兰－－－－－－－－－－－－－－goering cymbidium
螺栓中英文对照
螺栓中英文对照 ： 六角螺丝(栓) HEX HEAD CAP SCREWS(HEX BOLTS)六角机械螺丝HEX HEAD MACHINE BOLTS六角木牙螺丝HEX LAG BOLTS四角螺丝SQUARE HEAD BOLTST头螺丝T HEAD BOLTS马车螺丝CARRIAGE BOLTS环首螺丝EYE BOLTS内六角孔螺丝HEX SOCKET CAP SCREWS固定螺丝SET SCREWS螺椿栓STUD BOLTS螺旋椿SCREW STUDS轮壳螺栓WHEEL BOLTS翼形螺丝WING SCREWS自攻螺丝SELF TAPPING SCREWS自削螺丝THREAD CUTTING SCREWS钻尾螺丝SELF DRILLING SCREWS旋入螺丝DRIVE SCREWS机械螺丝MACHINE SCREWS木螺丝WOOD SCREWS家具螺丝FURNITURE SCREWS塑板螺丝CHIPBOARD SCREWS墙用螺丝DRYWALL SCREWS基础螺栓FOUNDATION BOLTSU型螺栓U BOLTS勾头螺栓HOOK BOLTS套挂螺丝TOGGLE BOLTS突缘螺丝FLANGE BOLTS轨道螺栓(鱼尾螺丝) TRACK BOLTS耐候钢螺丝CORTEN STEEL HEAVY HEX BOLTS扭矩控制螺栓T. C.BOLTS高张力螺栓HIGH STRENGTH BOLTS剪力钉(焊接螺丝) WELDING STUDS螺丝附华司组合SCREWS AND WASHERS ASSEMBLED(SEMS)大尺寸螺栓BIG SIZE BOLTS不锈钢小螺丝STAINLESS STEEL SHEET METAL SCREWS不锈钢大螺丝STAINLESS STEEL BOLTS铜螺丝BRASS SCREWS铝螺丝ALUMINUM SCREWS合金钢螺丝ALLOY STEEL SCREWS电子螺丝ELECTRONIC SCREWS微小精密螺丝MICRO SCREWS塑胶螺丝PLASTIC SCREWS复合材料用螺丝PARTICLE BOARD SCREWS钛合金螺丝TITANIUM ALLOY BOLTS钛、锆、钼、铌等螺丝、零件、材料 TI,ZR,MO,NB PARE METAL BOLTS PARTS拇指螺丝THUMB SCREWS双头牙螺丝DOUBLE END SCREWS HANGER BOLT车辆(汽车)螺丝、螺帽AUTOMOTIVE FASTENERS航太用螺丝AEROSPACE FASTENERS飞机特殊扣件SOURCE CONTROL BOLTS拉栓BLIND BOLTS面板螺丝PANEL FASTENERS电梯螺丝ELEVATOR BOLTS 四角头固定螺丝SQUARE SET SCREWS大头马车螺丝STEP BOLTS单向螺丝ONE WAY LAG SCREWS管夹螺丝HOSE CLAMP SCREWS不锈钢内六角螺丝STAINLESS STEEL HEX SOCKET CAP SCREWS铰链螺丝HINGE SCREWS货柜螺丝CONTAINER SCREWS复合材料钻尾螺丝BI-METAL SELF DRILLING SCREWS三角牙螺丝TRILOBULAR THREAD SCREWS高低牙螺丝HIGH LOW SCREWS夹板用螺丝PARTICLE BOARD SCREWS马桶螺丝TOILET CLOSET BOLTS特长螺丝SPECIAL
国外著名大学校训(中英文对照)
国外著名大学校训（中英对照版） 1、哈佛大学Harvard University Let Plato be your friend,and Aristotle,but more let your friend be truth. 与亚里士多德为友,与柏拉图为友,更与真理为友. 2、杜尔大学Drew University Freely have you received;freely give 自由地接受；自由地给予 3、夏威夷大学University of Hawaii Above all nations is humanity 人性超越国界或：人性超越种族 4、斯坦佛大学Stanford University the wind of freedom blowsaZ 愿学术自由之风劲吹 5、约翰霍普金斯大学Johns Hopkins University更多信息请访问： The truth shall make you free 真理必叫你们得以自由 这句话可追溯于新约圣经的约翰福音第八章32节“你们必晓得真理、真理必叫你们得以自由”英文是:“And ye(you)shall know the truth,and the truth shall make you free.”(King James version)。
Man,the servant and interpreter of nature 人类是大自然的理解者和仆人或：理解自然；服务自然 7、北达科他大学University of North Dakota Intelligence,the Basis of Civilization 才智是文明的基础 8、麻省理工学院MIT Mind and Hand 既学会动脑，也学会动手 这真是工程院校的校训。反映了MIT的创建者的办学理想-教育的内容一定要有它的实践意义。 9、华盛顿大学Washington University Strength through Truth 力量借助于真理 10、康涅狄克大学University of Connecticut He who transplants sustains *“He who transplants sustains”也是康州的州训，它反映了当初北美的殖民者的信念：上帝(He)，把他们从英格兰迁移(transplant)到北美大陆，会继续帮助他们，供给(sustain)他们。用一个长句子表达这句话，可以是：“God,who transplants us,sustain us.”Or“God,who the colonists believed had Transp lanted them from England to the New World,where he continued to sustain them.”
各种花的英文名
iris 蝴蝶花hon eysuckle 金银花 chrysanthemum 菊花 carnation 康乃馨 orchid 兰花 canna 美人蕉 jasmine 茉莉花 daffodil 水仙花 peony 牡丹 begonia 秋海棠 cactus 仙人掌 christmas flower 圣诞花/一品红 poppy 罂粟 tulip 郁金香 chi nese rose 月 季 violet 紫罗兰 peach flower 桃花 aloe 芦荟 mimosa 含羞草 dandelion 蒲公英 plum bolssom 梅花中国水仙new year lily
石榴pomegranate 月桂victor's laurel 报春花polyanthus 木棉cotton tree 紫丁香lilac 吊钟lady's eardrops 紫荆Chinese redbud 百合lily 紫罗兰wall flower 桃花peach 紫藤wisteria 杜鹃azalea 铃兰lily-of-the-valley 牡丹tree peony 银杏ginkgo 芍药peony 蝴蝶兰moth orchid 辛夷violet magnolia 蟹爪仙人掌Christmas cactus 玫瑰rose 郁金香tulip
非洲堇African violet 栀子花cape jasmine 木槿rose of Sharon 风信子hyacinth 百子莲African lily 牵牛花morning glory 君子兰kefir lily 荷包花lady's pocketbook 含笑花bana shrub 非洲菊African daisy 含羞草sensitive plant 茉莉Arabian jasmine 猪笼草pitcher plant 凌霄花creeper 树兰orchid tree 康乃馨coronation 荷花lotus 鸢萝cypress vine 菩提botree 大理花dahlia
关于螺丝的中英文对照
(浏览56次) No.英文单词简写中文 1 screw scr螺丝 2 nut nut螺母 3 washer wash垫圈 4 head hd头 5 thread thre螺纹 6 coating coat镀层 7 rivet riv铆钉 8 standoff stdoff内外六角钉 9 driver driv穴 10 hexagon hexa六角 11 tooth tooth齿 12 lock lck锁 13 spring spr弹簧 14 wave wave波浪型 15 pitch pitch牙距 16 partial thread PT半螺纹 17 PT PT一种螺纹形式 18 Full Thread FT全螺纹 19 silver silv银
1 / 27 20 cone cone锥形 21 Eco-syn Eco 30度牙的一种螺纹 22 ThreadForming TF自攻螺纹 23 Self Tapping self tapp自切屑螺纹 24 pin pin销 25 shaft Shaf轴 26 steel St铁 27 stainless steel SS不锈钢 28 Brass(Cu) Bras(Cu)铜 29 Aluminum AL铝 30 Rubber Rub橡胶 31 machine screw mech scr机制螺丝（机牙螺丝） 32 SEM screw SEM Scr组合螺丝 33 Material material材料 34 Grade GD等级 35 Finish Finish表面处理 36 Point Point点 37 Clamp Clam夹子 38 internal Int内 39 external ext外
信用证中英文对照翻译
信用证条款中英文对照——基础 27: Sequence of total 序列号 1/1 指只有一张电文 40A: Form of documentary credit 跟单信用证形式IRREVOCABLE 不可撤消的信用证 20: Data of issue 12345678 信用证号码 31C: Date of issue 开证日精 2002XXXX 31D: Date and place of expiry 信用证有效期 2002XXXX BENEFICIARY 'S COUNTRY 有效地 50: Applicant 信用证开证审请人（你们的客户名）ABC CO., LTD. CHINA 59: Beneficiary 受益人（你们公司名） EFG CO., LTD. ADDRESS 32B: Currency code amount 信用证项下的金额 USD XXXXXXX, 41D: Available with 议付适用银行 ANY BANK BY NEGOTIATION 任何议付行 42C: Draft at 开汇票 XXX DAYS AFTER SIGHT FOR FULL INVOICE V ALUE 见票XXX 天付款（发票全额） 42A: Drawee 付款人 ABOCCNBJXXX AGRICULTURAL BANK OF CHINA, XXX BRANCH 某农业银行某支行 43P: Partial shipment 是否允许分批装运 ALLOWED 可以 43T: Transshipment ALLOWED 允许转运 44A: Taking charge 装船港口 XXXXXX PORT 44B: For transportation to 目的港 CHINESE PORT 44C: Latest date of shipment 最后装船期 2002XXXX 45A: Description goods and/or services 货物/ 服务描述 GENERAL MERCHANDISE 日用品 46A: Documents required 须提供的单据文件 1. COMMERCIAL INVOICE IN TRIPLICATE 一式三份商业发票 2. FULL SET OF CLEAN ON BOARD B/L MARKED FREIGHT PREPAID MADE OUT TO ORDER OF SHIPPER AND NOTIFYING APPLICANT
常见花的英文单词新选
常见花的英文单词 中国水仙new year lily 石榴pomegranate 月桂victor's laurel 报春花polyanthus 木棉cotton tree 紫丁香lilac 吊钟lady's eardrops 紫荆Chinese redbud 百合lily 紫罗兰wall flower 桃花peach 紫藤wisteria 杜鹃azalea 铃兰lily-of-the-valley 牡丹tree peony 银杏ginkgo 芍药peony 蝴蝶兰moth orchid 辛夷violet magnolia 蟹爪仙人掌Christmas cactus 玫瑰rose 郁金香tulip 茶花common camellia 千日红common globe-amaranth 非洲堇African violet 栀子花cape jasmine 木槿rose of Sharon 风信子hyacinth 百子莲African lily 牵牛花morning glory 君子兰kefir lily 荷包花lady's pocketbook 含笑花banana shrub 非洲菊African daisy 含羞草sensitive plant 茉莉Arabian jasmine 猪笼草pitcher plant 凌霄花creeper 树兰orchid tree 康乃馨coronation 鸡冠花cockscomb
荷花lotus 鸢萝cypress vine 菩提botree 大理花dahlia 圣诞百合Christmas bell 一串红scarlet sage 紫薇crape myrtle 勿忘我forget-me-not 睡莲water lily 文心兰dancing lady 吊兰spider plant 白头翁pappy anemone 向日葵sunflower 矢车菊cornflower 竹bamboo 金鱼草snapdragon 夹竹桃oleander 金盏花pot marigold 月季花china rose 金银花honeysuckle 长春花old maid 金莲花garden nasturtium 秋海棠begonia 非洲凤仙African touch-me-not 美人蕉canna 曼陀罗angel's trumpet 晚香玉tuberose 梅花flowering apricot 野姜花ginger lily 圣诞红common poinsettia 菊花chrysanthemum 虞美人Iceland poppy 昙花epiphyllum 鸢尾iris 龙胆royal blue 腊梅winter sweet 麒麟花crown of thorns 木芙蓉cotton rose 九重葛paper flower 火鹤花flamingo flower 三色堇tricolor viola 嘉德丽亚兰cattleya
螺丝名词中英文对照
摘要：螺丝名词中英文对照No. 单词简写中文 1 screw scr 螺丝 2 nut nut ... 螺丝名词中英文对照 No. 单词简写中文 1 screw scr 螺丝 2 nut nut 螺母 3 washer wash 垫圈 4 head hd 头 5 thread thre 螺纹 6 coating coat 镀层 7 rivet riv 铆钉 8 standoff stdoff 内外六角钉 9 driver driv 穴 10 hexagon hexa 六角 11 tooth tooth 齿 12 lock lck 锁 13 spring spr 弹簧 14 wave wave 波浪型 15 pitch pitch 牙距 16 partial P T 半螺纹 thread 17 PT PT 一种螺纹形式 18 Full FT 全螺纹 Thread 19 silver silv 银 20 cone cone 锥形 21 Eco-syn Eco 30度牙的一种螺纹 22 Thread TF 自攻螺纹 Forming 23 Self self tapp 自切屑螺纹 Tapping 24 pin pin 销 25 shaft Shaf 轴
26 steel St 铁 27 stainless SS 不锈钢 steel 28 Brass(Cu) Bras(Cu) 铜 29 Aluminum AL 铝 30 Rubber Rub 橡胶 31 machine mech scr 机制螺丝 screw 32 SEM screw SEM Scr 组合螺丝 33 Material material 材料 34 Grade GD 等级 35 Finish Finish 表面处理 36 Point Point 点 37 Clamp Clam 夹子 38 internal Int 内 39 external ext 外 40 thickness / 厚度 41 length / 长度 42 hole / 孔 43 Metric Metcric 公制 44 DIN / 德标 45 ANSI / 美标 46 JIS / 日标 紧固件类英语词汇 白铁盖螺丝A2(18-8)CAP SCREWS 水平调整螺丝ADJUSTED LEVELING SCREWS 航太扣件AEROSPACE FASTENERS 合金钢螺丝(栓) ALLOY STEEL SCREWS (BOLTS) 铝螺丝ALUMINUM SCREWS 车辆(汽车)螺丝、螺帽AUTOMOTIVE FASTENERS 复含材料钻尾螺丝BI-METAL SELF DRILLING SCREWS 大尺寸螺丝BIG SIZE BOLTS 公母螺丝组BINDER POST & SCREW SET