WHO 986号报告附录2 中英文
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles
附录2 世界卫生组织（WHO）药品GMP主要原理
目录
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 世界卫生组织药品GMP主要原理 (1)
Introduction 介绍 (5)
General considerations 总则 (7)
Glossary 术语表 (7)
Quality management in the medicines industry: philosophy and essential elements3 药业的质量管理：理念和要素3 (13)
1.Pharmaceutical quality system药品质量系统 (15)
Quality risk management 质量风险管理 (18)
Product quality review产品质量回顾 (18)
2.Good manufacturing practices for pharmaceutical products 药品生产质量管理规范 (19)
3.Sanitation and hygiene清洁和卫生 (21)
4.Quali?cation and validation确认和验证 (21)
https://www.sodocs.net/doc/635992431.html,plaints 投诉 (22)
6.Product recalls 产品召回 (23)
7.Contract production and analysis 委托生产和分析 (24)
General 概述 (24)
The contract giver 委托方 (25)
The contract acceptor 受托方 (25)
The contract 合同 (26)
8.Self-inspection, quality audits and supplier’s audits and approval 自检、质量审计、供应商审计和批
准27
Items for self-inspection 自检项目 (27)
Self-inspection team 自检团队 (28)
Frequency of self-inspection 自检频率 (28)
Self-inspection report 自检报告 (28)
Quality audit 质量审计 (28)
Suppliers’ audits and approval 供应商审计和批准 (28)
9.Personnel 人员 (29)
General 概述 (29)
Key personnel 关键人员 (29)
10.Training 培训 (34)
11.Personal hygiene 个人卫生 (34)
12.Premises 厂房 (35)
General 概述 (35)
Ancillary areas 辅助区域 (36)
Storage areas 仓储区域 (37)
Weighing areas 称量区域 (38)
Production areas 生产区域 (38)
Quality control areas 质量控制区域 (39)
13.Equipment 设备 (40)
14.Materials 物料 (41)
General 概述 (41)
Starting materials 原辅料 (41)
Packaging materials 包装材料 (43)
Intermediate and bulk products 中间产品和待包装品 (43)
Finished products 成品 (44)
Rejected, recovered, reprocessed and reworked materials 拒绝的、回收的、重新加工的和返工的物料 (44)
Recalled products 召回产品 (44)
Returned goods 退回货物 (44)
Reagents and culture media 试剂和培养基 (45)
Reference standards 标准品 (45)
Miscellaneous 其他 (46)
15.Documentation 文件 (46)
General 概述 (47)
Documents required 所需文件 (48)
16.Good practices in production 生产质量管理规范 (57)
General 概述 (57)
Prevention of cross-contamination and bacterial contamination during production 在生产过程中避免交叉污染和细菌污染 (58)
Processing operations 生产操作 (60)
Packaging operations 包装操作 (61)
17. Good practices in quality control 质量控制管理规范 (62)
Control of starting materials and intermediate, bulk and ?nished products 原辅料、中间产品、待包装品和成品的控制 (64)
Test requirements 检验要求 (65)
Batch record review 批记录审核 (67)
Stability studies 稳定性试验 (68)
References 参考资料 (68)
Introduction 介绍
The ?rst WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-?rst World Health Assembly under the title Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties and was accepted.
1967年，根据第20届世界卫生大会的要求（WHA20.34号决议），顾问组起草了第一版世界卫生组织的生产质量管理规范的正文。随后它以《药品和药物学制造和质量控制中生产质量管理规范的要求草案》的标题被提交给第21届世界卫生大会，并获得批准。
The revised text was discussed by the WHO Expert Committee on Speci?cations for Pharmaceutical Preparations in 1968 and published as an annex to its twenty-second report. The text was then reproduced (with some revisions) in 1971 in the Supplement to the second edition of The International Pharmacopoeia.
1968年，药物制剂质量标准的世界卫生组织专家委员会讨论了修订后的正文，并将其发布为第21份报告的附录。然后在1971年，该正文被复制（做了一些修订）在第二版国际药典的附录中。
In 1969, when the World Health Assembly recommended the ?rst version of the WHO Certi?cation Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in resolution WHA22.50, it accepted at the same time the GMP text as an integral part of the Scheme. Revised versions of both the Certi?cation Scheme and the GMP text were adopted in 1975 by resolution WHA28.65. Since then, the Certi?cation Scheme has been extended to include the certi?cation of:
1969年，当世界卫生大会提出WHA22.50号决议《世界卫生组织有关进入国际商务的药品的质量的认证计划》时，它同时批准了GMP正文，作为该计划的一个主要部分。1975年，修订后版本的认证计划和GMP正文在WHA28.65号决议中被采用。从此，认证计划的范围扩大到包括以下内容：
— veterinary products administered to food-producing animals;
产出食品的动物所用的兽药；
— starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and the importing Member State;
制剂中所用的原辅料，当它们同时受到出口成员国和进口成员国的法规控制时；
— Information on safety and efficacy (resolution WHA41.18, 1988).
安全性和有效性的信息（1988年WHA41.18号决议）。
In 1992, the revised draft requirements for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document (1). “Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of quality assurance (QA) as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation.
1992年，修订版本的GMP要求被分为三个部分，其中第一和第二部分与此文件（1）中的相同。“药业的质量管理：理念和基本要素”概括了质量保证（QA）的一般概念和主要成分或GMP的子系统，这是顶级管理层、以及生产和质量控制管理层的共同职责。这些包括卫生、验证、自检、人员、厂房、设备、物料和文件。
“Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.
“生产和质量控制的良好规范”提供了为了执行质量保证的一般性原则生产和质量控制人员分别需要采取的
行动的指导原则。
These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/ qsm/activities/quality assurance/gmp/gmpcover. html).
这两个部分随后补充了更多的指导原则，这些指导原则是这些药品GMP的主要部分。所有这些正文均在药品网页（http.www.who.int/ medicines/ organization/qsm/activities/qualityassurance/gmp/gmpcover. html）上。
Considerable developments in GMP have taken place in the intervening years, and important national and international documents, including new revisions, have appeared (2-5). Thus there is a necessity to revise the main principles and incorporate the concept of validation.
其中几年GMP获得了重大发展，重要的国家和国际文件，包括出现了新的修订版本（2-5）。因此有必要修订主要原则，并整合入验证概念。
Among other feedback which was discussed during the consultation on WHO guidelines for medicines quality assurance, quality control (QC) laboratories and transfer of technology on 27–31 July 2009, the need was identi?ed to incorporate a new section on “Product quality review” under Chapter 1: “Quality assurance”.
在2009年7月27日至31日，对药品质量保证、质量控制实验室和技术转移的世界卫生组织指导原则进行磋商的过程中讨论的其他反馈中，确认了在第1章：“质量保证”中整合入新的节“产品质量回顾”的需要。
In addition, several updates were suggested to further enhance the guidelines and include the concept of risk management, replacing “drugs” by the term “medicines” and newly introduce the concept of a “quality unit”.
另外，提出了几个更新，以进一步提高指导原则，包括风险管理的概念，用术语“medicines”替代“drugs”，新引入“质量部门”的概念。
During 2012 the Secretariat was made aware that the current Good manufacturing practices (GMP) for pharmaceutical products: main principles, published as Annex 3 in the WHO Technical Report Series, No. 961, 2011, would need updating
(http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html ? Quality assurance of pharmaceuticals: a compendium of guidelines and related materials).
2012年秘书处注意到，当前的药品良好生产规范（GMP）：主要原理（2011年，961号WHO技术系列报告，附件3）需要更新。
(http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html ?药物质量保证：指南纲要和相关材料)。
The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the need for an update during its forty-seventh meeting and agreed to pursue the matter accordingly. The following sections were updated in the newly revised version and, after the usual consultation process, were presented to the forty-eighth Expert Committee for adoption:
在第47次WHO专家委员会医药制剂质量规范会议上，专家就有关指南更新事宜进行了商讨，最终同意跟进更新指南。在一系列的咨询过程后，新的指南修订版本对以下部分进行了更新，并被第48次专家委员会采纳。
Section: Pharmaceutical quality system 制药质量系统
Section 2: 2. Good manufacturing practices for pharmaceutical products 药物良好生产规范
Section 7: Contract production, analysis and other activities 委托生产，检测和其他行为
Section 17: 17. Good practices in quality control质量控制良好规范
World Health Organization WHO Technical Report Series, No. 986, 2014 世界卫生组织技术报告系列，编号986，2014年
General considerations 总则
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certi?cation Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry.
被批准的制剂产品（上市许可）只能由获得批准的制造商（生产许可持有人）制造，由国家法规当局定期检查该生产商的各项活动。应使用这个GMP的指南作为标准，通过评估生产许可申请和作为生产厂房检查的一个基础来证明GMP状态，它是《世界卫生组织有关进入国际商务的药品的质量的认证计划》的一个组成元素。它还可能用作政府药品检察官、工业界生产、质量控制和质量保证人员的培训材料。
The guide is applicable to operations for the manufacture of medicines in their ?nished dosage forms, including large-scale processes in hospitals and the preparation of supplies for use in clinical trials.
该指南适用于药物以其成品剂型的制造操作，包括医院内的大规模工艺和用于临床试验的制剂。
The good practices outlined below are to be considered general guides1, and they may be adapted to meet individual needs. The equivalence of alternative approaches to QA, however, should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personnel safety is also newly recommended (Annex 7). The manufacturer should assure the safety of workers and take the necessary measures to prevent pollution of the external environment.
下述良好规范为一般指南1；它们可能被用于满足个性化要求，但（此种情况下）需要验证质量保证（QA）替代方法的等效性。整个指南不包括制造中所牵涉的人员的安全性方面或环境保护：这些一般受到国家法规的管理。还新提出了新的生产和人员安全性风险相关的危害分析的概念（附录7）。制造商应保证工作人员的安全性，并采取必要措施来防止外部环境的污染。
International Nonproprietary Names (INN) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.
应与其他指定名称一起使用世界卫生组织指定的原料药的国际非专利药名（INN）。
Glossary 术语
The de?nitions given below apply to the terms used in this guide.
以下给出的定义适用于本指南中所用术语。
active pharmaceutical ingredient (API) 原料药
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
打算用于药物制剂制造中的任何物质或物质的混合物，当使用时，它成为该药物制剂的活性成分。这些物质用于提供药理活性或其他诊断、治愈、缓解、治疗或预防疾病的直接效果，或影响实体结构和功能的效果。
airlock 气闸间
An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered.
An airlock is designed for use either by people or for goods and/or equipment.插入两个以上房间中的，具有两个以上门的封闭空间，如不同洁净级别之间，为了控制那些需要进入的房间之间的气流。为了人员或货物和/或设备的使用设计气闸间。
authorized person 受权人
The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of ?nished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.
国家法规当局认可的、负责保证制造、检验和批准放行的每批成品符合该国强制推行的法律法规的人员。
batch (or lot) 批
A de?ned quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a ?nal homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a de?ned fraction of the production, characterized by its intended homogeneity. The batch size can be de?ned either as a ?xed quantity or as the amount produced in a ?xed time interval.
规定量的原辅料、包装材料、或用单一工艺或一系列工艺生产的有望均一的产品。可能有时有必要将一批分为若干亚批，这些亚批稍后共同形成一个最终均一的批次。在终端灭菌的情况下，批量由高压灭菌器的容量所决定。在持续制造中，批次必须与规定的生产部分所对应，具有预期的均一性。批量可规定为固定的量或在固定时间周期内生产出来的量。
batch number (or lot number) 批号
A distinctive combination of numbers and/or letters which uniquely identi?es a batch on the labels, its batch records and corresponding certi?cates of analysis, etc.
数字和/或字母的独特组合，在标签、它的批记录和相应的检验报告书上等位置，用来唯一地鉴别一个批次。
batch records 批记录
All documents associated with the manufacture of a batch of bulk product or ?nished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the ?nal product.
所有与一批待包装品或成品制造相关的文件。它们提供了每批产品和所有与终产品质量有关的环境的历史。
bulk product 待包装品
Any product that has completed all processing stages up to, but not including, ?nal packaging.
任何已完成所有生产工序，直至但不包括最终包装的产品。
calibration 校准
The set of operations that establish, under speci?ed conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
在指定条件下所进行的一套操作，用来建立一台用于测量（特别是称量）、记录和控制的仪器或系统所显示的值，或实物量具所表示的值，和相应的标准品的已知值之间的关系。应建立测量结果的可接受限度。
clean area 洁净区
An area with de?ned environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.
对微粒和微生物污染有规定的环境控制，并在这样一种方式下建造和使用的区域，以减少向该区域内引入、产生和保留污染物。
consignment (or delivery) 交付的货物
The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
由一个制造商生产、为了响应一份特定的请求或订单一次供应的一定量的药物。一份交付的货物可能包括一个或多个包装或容器，并可能包括属于多于一批的物料。
contamination 污染
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.
在生产、取样、包装或重新包装、储存或运输过程中，向原辅料或中间产品中或上，非期望地引入化学性或微生物性质的杂质，或异物。
critical operation 关键操作
An operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.
生产工艺中可能导致药品质量变化的操作。
cross-contamination 交叉污染
Contamination of a starting material, intermediate product or ?nished product with another starting material or product during production.
在生产过程中，一种原辅料、中间产品或成品受到另一种原辅料或产品的污染。
?nished product 成品
A ?nished dosage form that has undergone all stages of manufacture, including packaging in its ?nal container and labeling.
已经经历了所有制造工序的最终制剂，包括包装在其最终容器中，并贴标签。
in-process control 中控
Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its speci?cations. The control of the environment or equipment may also be regarded as a part of in-process control.
生产过程中进行的确认，为了监控和在必要时调整工艺，以保证产品符合其质量标准。环境或设备控制也可被视为中控的一部分。
intermediate product 中间产品
Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.
部分处理的产品，必须经历进一步的生产工序，方可成为待包装品。
large-volume parenterals 大容量注射液
Sterile solutions intended for parenteral application with a volume of 100 ml or more in one container of the ?nished dosage form.
最终制剂的一个容器中容量大于100毫升的，用于注射的无菌溶液。
manufacture 制造
All operations of purchase of materials and products, production, quality control (QC), release, storage and distribution of pharmaceutical products, and the related controls.
采购材料和产品、生产、质量控制、放行、储存和药品销售、以及相关控制的所有操作。
manufacturer 制造商
A company that carries out operations such as production, packaging, repackaging, labeling and relabeling of pharmaceuticals.
进行诸如药物生产、包装、重新包装、贴签和重新贴签操作的公司。
marketing authorization (product license, registration certi?cate) 上市许可（产品许可证、注册证书）A legal document issued by the competent medicines regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized speci?cations of its ingredients and of the ?nal product itself, and includes details of packaging, labeling and shelf-life.
药品法规当局颁发的，建立产品的详细成分和处方、建立其成分和终产品本身的药典标准或其他认可的质量标准的，包括详细的包装、标签和有效期的法律文书。
master formula 生产工艺规程
A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a speci?ed quantity of a ?nished product as well as the processing instructions, including the in-process controls.
一个或一套文件，规定原辅料及其用量、包装材料、规程的描述和所要求的注意事项，还有工艺指令，包括中控，以生产规定量的成品。
master record 主记录
A document or set of documents that serve as a basis for the batch documentation (blank batch record).
一个或一套文件，作为批文件的基础（空白批记录）。
packaging 包装
All operations, including ?lling and labeling, that a bulk product has to undergo in order to become a ?nished product. Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized, would not normally be regarded as part of packaging.
包括填充和贴签的所有操作，待包装品必须经历此工序以成为成品。在无菌条件下填充无菌产品，或填充终端灭菌的产品，通常被视为包装的一部分。
packaging material 包装材料
Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
在药品包装中所用的任何物料，包括印刷材料，但不包括任何用于交通运输的外包装。包装材料根据它们是否与产品直接接触分为内包装材料或外包装材料。
pharmaceutical product 药品
Any material or product intended for human or veterinary use presented in its ?nished dosage form or as a starting material for use in such a dosage form that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state.
任何以其最终制剂或在这样一种制剂中所用的原辅料的形式以供人用或兽用的物料或产品，受到出口国和/或进口国药品法规的控制。
production 生产
All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labeling and relabeling, to completion of the ?nished product.
所有在药品制备中牵涉到的操作，从物料接收到生产加工、包装和重新包装、贴签和重新贴签、直到完成成品。
quali?cation 确认
Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the word “validation” is sometimes extended to incorporate the concept of quali?cation.
证实任何厂房、系统和设备项目的运行正确，并能实际上获得预期的结果的活动。“验证”的意义有时延伸至能够包含确认的概念。
quality assurance See Part One (6). 质量保证见第一部分（6）。
quality control See Part One (6). 质量控制见第一部分（6）。
quality unit(s) 质量部门
An organizational unit independent of production which ful?ls both quality assurance (QA) and quality control (QC) responsibilities. This 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.
独立于生产的组织性部门，该部门履行质量保证（QA）和质量控制（QC）职责。这可以是独立的QA和QC 部门，或一个单独的个人或组织，这依赖于组织的规模和构架。
quarantine 待验
The status of starting or packaging materials, intermediates, or bulk or ?nished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
当等待它们的放行、判不合格或重新加工的决定时，物理隔离或用其他有效方法隔离原辅料或包装材料、中间产品、待包装品或成品的状态。
reconciliation 平衡
A comparison between the theoretical quantity and the actual quantity.
理论量和实际量之间的对比。
recovery 回收
The introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a de?ned stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or the recovery of used materials for a separate use.
在制造的规定工序中，将具有所要求的质量的所有或部分之前的批次（或重新蒸馏的试剂和类似产品）引入另一批中。它包括去除废弃物中的杂质，以获得纯物质或回收用过的物料用于单独用途。
reprocessing 重新加工
Subjecting all or part of a batch or lot of an in-process medicine, bulk process intermediate (?nal biological bulk intermediate) or bulk product of a single batch/lot to a previous step in the validated manufacturing process due to failure to meet predetermined speci?cations. Reprocessing procedures are foreseen as occasionally necessary for biological medicines and, in such cases, are validated and pre-approved as part of the marketing authorization.
因为不符合预定的质量标准，使用验证过的生产工艺将一批中间药品、待包装工艺中间体（最终生物待包装中间体）或单一批次的待包装品重新进行上一工序。对于生物制品来说，可以预见到有时重新加工程序是必要的，并且在这些情况下，作为上市许可的一部分经过了验证，获得了预先批准。
reworking 返工
Subjecting an in-process or bulk process intermediate (?nal biological bulk intermediate) or ?nal product of a single batch to an alternate manufacturing process due to a failure to meet predetermined speci?cations. Reworking is an unexpected occurrence and is not pre-approved as part of the marketing authorization.
因为不符合预定的质量标准，使用替代性的生产工艺加工中间产品或待包装工艺中间体（最终生物待包装中间体）或单一批次的终产品。返工是意外发生的，没有作为上市许可的一部分获得预先批准。
self-contained area 独立区
Premises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.
对一个操作的所有方面提供完整和完全分离的厂房，包括人员和设备移动，具有良好建立的程序、控制和监控。这包括物理屏障和独立的空气处理系统，但没有必要是两栋区分开来的独立的建筑物。
speci?cation 质量标准
A list of detailed requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.
详细要求的列表，生产过程中使用或获得的产品或物料必须遵守。它们作为质量评估的基础。
standard operating procedure (SOP) 标准操作规程
An authorized written procedure giving instructions for performing operations not necessarily speci?c to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-speci?c master and batch production documentation.
经认可的书面规程，给出所进行操作的指令，不必针对给定的产品或物料（如设备操作、维护和清洁；验证；厂房清洁和环境控制；取样和检查）。某些SOP可用于补充产品特有的主文件和批生产文件。
starting material 原辅料
Any substance of a de?ned quality used in the production of a pharmaceutical product, but excluding packaging materials.
药品生产中所用的具有规定质量的物质，但不包括包装材料。
validation 验证
Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also quali?cation).
根据GMP原则，证实任何程序、工艺、设备、物料、活动或系统实际上能够获得预期的结果的活动（同见确认）。
Quality management in the medicines industry: philosophy and essential elements3
药业的质量管理：理念和要素3
In the medicines industry at large, quality management is usually de?ned as the aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:
一般在制药业，质量管理通常被定义为决定和执行“质量政策”的管理功能的方面。即一个组织有关质量的整体目的和方向，由顶级管理层正式表达和批准。质量管理的基本元素为：
— an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and
适当的基础机构或“质量体系”，包括组织架构、规程、工艺和资源；
— systematic actions necessary to ensure adequate con?dence that a product (or service) will satisfy given requirements for quality.
必要的系统活动，以保证有充分的信心使产品（或服务）能够满足给定的质量要求。
The totality of these actions is termed “quality assurance” (QA). Within an organization, QA serves as a management tool. In contractual situations, QA also serves to generate con?dence in the supplier. The concepts of QA, GMP, QC and quality risk management (QRM) are interrelated aspects of quality management and should be the responsibility of all personnel. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
QA、GMP、QC和质量风险管理（QRM）的概念是质量管理的相互关联的方面，并应该是所有人员的责任。在此描述它们，以强调它们的关系和它们对药品生产和控制的基础重要性。这些活动的整体被定义为“质量保证”（QA）。在一个组织内部，QA是一个管理工具。在合同状况下，QA也产生对供应商的信任。
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3Good manufacturing practices for pharmaceutical products, Part One. In: WHO Expert Committee on Speci?cations for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823); and in: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume 2, Second updated edition. Good manufacturing practices and inspection. Geneva, World Health Organization, 2007; and in: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Geneva, World Health Organization, 2010 (CD-ROM).
药品生产质量管理规范，第一部分。源自：药物制剂质量标准的世界卫生组织专家委员会。第32份报告。日内瓦，世界
卫生组织，1992年，附录1（世界卫生组织技术报告系列，编号823）；并源自：药物质量保证。指导原则和相关材料的摘要。第2卷，第2次更新的版本。生产质量管理规范和检查。日内瓦，世界卫生组织，2007年；并源自：药物质量保证。指导原则和相关材料的摘要。日内瓦，世界卫生组织，2010年（只读型光盘）。
1.Pharmaceutical quality system药品质量系统
1.1Principle. The manufacturer must assume responsibility for the quality of the pharmaceutical products to
ensure that they are fit for their intended use, comply with the requirements of the marketing authorization 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 of staff in many different departments and at all levels within the company, the company’s suppliers and the distributors.
To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented pharmaceutical quality system (PQS) incorporating GMP and QRM
原则。生产商对药品质量负责，保证药品适用于预期用途，符合市场授权的要求，不会因为药品的安全、质量或有效性对患者的健康造成威胁。该质量目的的实现不仅是高层管理的职责，而且是需要公司各层、各部门员工，以及供应商和供销商的共同参与和承担义务。为保证质量目标的顺利实现，必须要有全面设计和正确执行的融合GMP和质量风险管理（QRM）的药品质量体系（PQS）。
1.2Senior management has the ultimate responsibility to ensure an effective PQS is in place, is adequately
resourced, and that roles, responsibilities, and authorities are defined, communicated and implemented
throughout the organization. Senior management’s leadership and active participation in the PQS is essential.
This leadership should ensure the support and commitment of staff at all levels and sites within the
organization to the PQS.
管理高层的最终职责是保证有效制药质量体系准备就绪，有充足的资源，可以达成质量目标；应清楚定义角色，职责，授权状况，在全公司内交流，执行。高层管理的领导和参与对于药品质量体系（PQS）来讲必不可少。管理高层的领导应确保组织内所有层面的员工对PQS的支持和认同。
1.3Quality management is a wide-ranging concept covering all matters that individually or collectively influence
the quality of a product. It is the totality of the arrangements made with the object of ensuring that
pharmaceutical products are of the quality required for their intended use. Quality management, therefore,
incorporates GMP and other factors, including those outside the scope of this guide, such as product design and development.
质量管理师一个广泛的概念，涵盖了所有独立或共同影响产品质量的方面。它是保证药品具有根据其预期用途所要求的质量的各种安排的整体。因此QA整合了GMP和其他因素，包括那些在此指南范围之外的因素，如产品设计和开发。
1.4GMP applies to the life-cycle stages from the manufacture of investigational medicinal products, technology
transfer, and commercial manufacturing, through to product discontinuation. The PQS can extend to the
pharmaceutical development life-cycle stage and should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. All parts of the PQS should be adequately resourced and maintained, including being provided with sufficient competent personnel, suitable premises, equipment and facilities.
GMP适用于从研究用药物产品的生产，技术转移和商业生产，到商品的终止的整个生命周期。PQS可以延伸到药物开发的生命周期阶段，应有助于产品的创新和持续改进，加强药物开发和生产活动的连接。
PQS的所有组成部分都应得到充足的资源支持和维护，包括提供充足的有资质人员，使用厂房，设备和设施。
1.5The PQS appropriate to the manufacture of pharmaceutical products should ensure that:
适用于药品生产的产品质量体系（PQS），应确保：
a)product realization is achieved by designing, qualifying, planning, implementing, maintaining and continuously
improving a system that allows the consistent delivery of products with appropriate quality attributes;
通过设计、质化、计划、实施、执行和持续改进质量体系，输出合格产品；
b)product and process knowledge is managed throughout all life-cycle stages;
产品和工艺知识管理覆盖整个生命周期阶段；
c)pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and
other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP);
药品的设计和开发考虑到了GMP要求和其他相关法典的要求，如那些实验室质量管理规范（GLP）7和临床质量管理规范（GCP）；
d)production and control operations are clearly specified in a written form and GMP requirements are adopted;
以书面形式清晰规定了生产和控制操作，并采用了GMP要求；
e)managerial responsibilities are clearly specified in job descriptions;
职务说明书中清晰规定了管理职责；
f)arrangements are made for the manufacture, supply and use of the correct starting and packaging materials, the
selection and monitoring of suppliers and for verifying that each delivery is the correct material from the
approved supply chain;
为正确的原辅料和包装材料的制造、供应和使用，供应商的选择和检测，确保正确物料是通过合格供应链提交做出了安排；。
g)all necessary controls on starting materials, intermediate products, and bulk products and other in-process
controls, calibrations and validations are carried out;
已对原辅料、中间产品和待包装品进行了必要的控制，其他中控、校准和验证也都已经进行；
h)the finished product is correctly processed and checked, according to the defined procedures;
已按照规定的程序正确处理和核对了成品；
i)pharmaceutical products are not sold or supplied before the authorized persons (see also sections 9.11 and 9.12)
have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of
pharmaceutical products;
只有在受权人（同见9.11和9.12节）已经证实每个生产批次的生产和控制均符合上市许可和任何其他有关药品生产、控制和放行的法规的要求之后，药品方可进行销售或供应；
j)processes are in place to assure the management of outsourced activities;
有工艺确保外包活动的管理；
k)satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf-life;
已有令人满意的安排以保证尽量由制造商储存药品，保证销售和随后的处理能够使其在有效期内质量稳定；
l)there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the PQS;
有定期评价QA体系有效性和适用性的自检和/或质量审计的规程；
m)product and processes are monitored and the results taken into account in batch release, in the investigation of deviations and, with a view to taking preventive action to avoid potential deviations occurring in the future;
对产品和工艺进行监测，监测结果应在批放行、偏差调查中考虑，以避免今后再次发生。
n)arrangements are in place for the prospective evaluation and approval of planned changes and their approval prior to implementation taking into account regulatory notification and approval where required. After
implementation of any change, an evaluation is undertaken to confirm that the quality objectives were achieved and that there was no unintended adverse impact on product quality;
建立措施，前瞻性评估计划性变更，批准前通知法规部门或等待法律部门的批准。所有变更实施后，都应进行评估，以确保达到变更目的，且变更对产品质量没有未预料到的负面影响。
o)regular reviews of the quality of pharmaceutical products are conducted with the objective of verifying the consistency of the process and identifying where there is a need for improvement;
对药物产品的质量进行常规回顾，以确保工艺的一致性和识别需要改进的地方。
p) a state of control is established and maintained by developing and using effective monitoring and control systems for process performance and product quality;
通过开发和使用有效的工艺特性和产品质量监控系统，维护控制体系。
q)continual improvement is facilitated through the implementation of quality improvements appropriate to the current level of process and product knowledge;
提升适用于当前工艺水平和产品知识的质量改善举措，不断地提升产品质量系统；
r)there is a system for QRM;
有质量风险管理体系;
s)deviations, suspected product defects and other problems are reported, investigated and recorded. An appropriate level of root cause analysis is applied during such investigations. The most likely root cause(s) should be identified and appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken. The effectiveness of CAPAs should be monitored.
报告、调查和记录偏差、可疑产品缺陷和其他问题；调查过程中应分析根本原因，鉴别和采取有效的纠正预防措施，并监控CAPA的有效性。
1.6There should be periodic management reviews, with the involvement of senior management, of the operation
of the PQS to identify opportunities for continual improvement of products, processes and the system itself.
Unless otherwise justified, such reviews should be conducted at least annually.
应进行定期的管理回顾（高层管理人员参与）P Q S操作，发现不断改进产品，工艺和系统本身的机会；如无适当理由，此类回顾应至少每年进行；
1.7The PQS should be defined and documented. A quality manual or equivalent documentation should be
established and should contain a description of the quality management system including management
responsibilities.
应对P Q S进行定义和归档。应建立质量手册或等同文件，文件中应包括管理层职责的质量管理系统。
Quality risk management 质量风险管理
1.8QRM is a systematic process for the assessment, control, communication and review of risks to the quality of
the medicinal product. It can be applied both proactively and retrospectively.
质量风险管理是一个评估、控制、交流和审核对药品质量的风险的系统程序。它可以通过前瞻性和回顾性的方式来实施。
1.9QRM should ensure that: 质量风险管理应保证
— the evaluation of the risk to quality is based on scienti?c knowledge, experience with the process and ultimately links to the protection of the patient;
在科学知识、工艺经验和最终联系到对患者保护的基础上来评估对质量的风险；
— the level of effort, formality and documentation of the QRM process is commensurate with the level of risk.
质量风险管理程序实施的水平、正式的手续和文件应与风险级别相称。
Product quality review产品质量回顾
1.10Regular, periodic or rolling quality reviews of all medicinal products, including export-only products, should
be conducted with the objective of verifying the consistency of the existing process, the appropriateness of
current speci?cations for both starting materials and ?nished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:
应进行有规律的、定期的或周而复始的所有药品的质量回顾，包括仅用于出口的产品，其目的是确认已有工艺的一致性，以及原辅料和成品的现行质量标准的适宜性，以突出任何趋势，并鉴别产品和工艺改进。
一般应每年进行和记录这些回顾，考虑到之前的回顾，并应至少包括：
a) a review of starting materials and packaging materials used for the product, especially those from new sources;
回顾产品所用的原辅料和包装材料，特别是那些来源于新供应商的材料；
b) a review of critical in-process controls and ?nished product results;
回顾关键中控和成品结果；
c) a review of all batches that failed to meet established speci?cation(s) and their investigation;
回顾不符合已建立的质量标准的所有批次及其调查；
d) a review of all signi?cant deviations or non-conformances, the related investigations and the effectiveness of
resultant corrective and preventive actions taken;
回顾所有重大偏差或不符合事项、相关的调查和相应采取的纠正预防措施的效果；
e) a review of all changes made to the processes or analytical methods;
回顾所有对工艺或分析方法的变更；
f) a review of dossier variations submitted, granted or refused;
回顾所递交的、批准的或拒绝的文件变更；
g) a review of the results of the stability monitoring programme and any adverse trends;
回顾稳定性监控计划和任何不良趋势的结果；
h) a review of all quality-related returns, complaints and recalls and the investigations performed at the time; 、
回顾所有质量相关的退货、投诉和召回，以及当时所进行的调查；
i) a review of adequacy of any other previous corrective actions on product process or equipment;
回顾对产品工艺或设备的任何其他之前的纠正措施的妥善性；
j)for new dossiers and variations to the dossiers, a review of post-marketing commitments;
对于新申报文件及其变更，回顾上市后承诺；
k)the quali?cation status of relevant equipment and utilities, e.g. heating, ventilation and air-conditioning (HVAC), water, or compressed gases; and
相关设备和公用设施的确认状态，如加热通风和空调系统（HVAC）、水系统或压缩空气系统；
l) a review of technical agreements to ensure that they are up to date.
回顾技术协议，以保证它们是现行的。
The manufacturer and marketing authorization holder, where different, should evaluate the results of this review and an assessment should be made whether corrective and preventive action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventive actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures should be veri?ed during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, or sterile products, where scienti?cally justi?ed. Where the marketing authorization holder is not the manufacturer, there should be a technical agreement in place between the various parties that de?nes their respective responsibilities in producing the quality review. The authorized person responsible for ?nal batch certi?cation, together with the marketing authorization holder, should ensure that the quality review is performed in a timely manner and is accurate.
制造商和上市许可持有人（若二者不同）应评估此回顾的结果，并评估是否进行纠正和预防性措施或相关的再验证。应记录这些纠正措施的原因。应及时有效地完成批准的纠正预防措施。应有管理程序持续管理和回顾这些措施，并在自检过程中确认这些程序的有效性。经过科学证明，质量回顾可以通过产品类型分类，如固体制剂、液体制剂或无菌制剂等。若上市许可持有人不是制造商，应有不同各方的技术协议，规定进行质量回顾过程中各方的责任。负责最终批放行的受权人应与上市许可持有人一起保证及时和准确地进行质量回顾。
2.Good manufacturing practices for pharmaceutical products 药品生产质量管理规范2.1GMP is that part of quality management which ensures that products are consistently produced and controlled
according to the quality standards appropriate to their intended use and as required by the marketing
authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Under GMP:
GMP是保证产品始终按照适用于其预定用途的质量标准以及上市许可的要求生产和控制的质量管理的部分。GMP的主要目的是降低任何药品生产中固有的风险，确保产品的质量，安全和有效性。在GMP 下：
a)all manufacturing processes are clearly de?ned, systematically reviewed in the light of experience, and
shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their speci?cations;
所有生产工艺都有清晰的规定、根据经验进行系统的审核，并显示出能够始终制造出具有符合其质量标准的具有所要求的质量的药品；
b)quali?cation and validation are performed;
进行了确认和验证；
c)all necessary resources are provided, including:
提供了所有必要的资源，包括：
（i） sufficient and appropriately quali?ed and trained personnel;
充足的有合适资质和培训过的人员；
（ii） adequate premises and space;
充足的厂房和空间；
（iii） suitable equipment and services;
合适的设备和服务；
（iv） appropriate materials, containers and labels;
适当的物料、容器和标签；
（v） approved procedures and instructions;
批准的规程和指令；
（vi） suitable storage and transport;
合适的仓储和运输；
（vii） adequate personnel, laboratories and equipment for in-process controls;
充足的中控人员、实验室和设备；
d)instructions and procedures are written in clear and unambiguous language, speci?cally applicable to the
facilities provided;
用清晰明白的语言书写指令和规程，特别应适用于所提供的设施；
e)operators are trained to carry out procedures correctly;
培训操作员正确执行规程；
f)records are made (manually and/or by recording instruments) during manufacture to show that all the steps
required by the de?ned procedures and instructions have in fact been taken and that the quantity and
quality of the product are as expected; any signi?cant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is
implemented;
室内设计空间-中英文对照1
室内设计空间-中英文对照 General: 一般 Plan - 平面图 Elevation -立面图 Section - 剖面图 Detail Drawing- 大样图 Ceiling Plan - 天花图 Plan: 平面 lighting layout Plan - 灯光设计图 Electrical Layout Plan - 电图 (一般指带有电制-socket 的图) Fire Service Layout Plan - 消防系统 MVAC Layout Plan - 空调系统 Detail Drawing: 详图 Floor Pattern Detail - 地板图 Stone Pattern Detail - 石图 Schedule: ( 附助图表 ) Lighting Schedule - 灯具表 1\ Florescent Light 2\ Spot Light (directional /non-directional) 3\ Light trough Socket Schedule - 电气表 Window and Door Schedule - 门窗表 Hardware Schedule - 五金器具表 Sanitary fixture Schedule - 洁具(卫生设备)表 家居篇: Living Room - 客厅 Dining Room - 饭厅 foyer - 玄关 Kitchen – Bath - 厕所、浴室 Study - 书房 Store - 贮物室 Master Bed Room - 主人房 Guest Bed Room - 客房 Suite - 套房 Balcony - 露台
中英文参考文献格式
中文参考文献格式 参考文献（即引文出处）的类型以单字母方式标识： M——专著，C——论文集，N——报纸文章，J——期刊文章，D——学位论文，R——报告，S——标准，P——专利；对于不属于上述的文献类型，采用字母“Z”标识。 参考文献一律置于文末。其格式为： （一）专著 示例 [1] 张志建.严复思想研究[M]. 桂林：广西师范大学出版社，1989. [2] 马克思恩格斯全集：第1卷[M]. 北京：人民出版社，1956. [3] [英]蔼理士.性心理学[M]. 潘光旦译注.北京：商务印书馆，1997. （二）论文集 示例 [1] 伍蠡甫.西方文论选[C]. 上海：上海译文出版社，1979. [2] 别林斯基.论俄国中篇小说和果戈里君的中篇小说[A]. 伍蠡甫.西方文论选：下册[C]. 上海：上海译文出版社，1979. 凡引专著的页码，加圆括号置于文中序号之后。 （三）报纸文章 示例 [1] 李大伦.经济全球化的重要性[N]. 光明日报，1998-12-27，（3） （四）期刊文章 示例 [1] 郭英德.元明文学史观散论[J]. 北京师范大学学报（社会科学版），1995（3）. （五）学位论文 示例 [1] 刘伟.汉字不同视觉识别方式的理论和实证研究[D]. 北京：北京师范大学心理系，1998. （六）报告 示例 [1] 白秀水，刘敢，任保平. 西安金融、人才、技术三大要素市场培育与发展研究[R]. 西安：陕西师范大学西北经济发展研究中心，1998. （七）、对论文正文中某一特定内容的进一步解释或补充说明性的注释，置于本页地脚，前面用圈码标识。 参考文献的类型 根据GB3469-83《文献类型与文献载体代码》规定，以单字母标识： M——专著（含古籍中的史、志论著） C——论文集 N——报纸文章 J——期刊文章 D——学位论文 R——研究报告 S——标准 P——专利 A——专著、论文集中的析出文献 Z——其他未说明的文献类型 电子文献类型以双字母作为标识： DB——数据库 CP——计算机程序 EB——电子公告
室内设计中英文对照
常用室内设计词汇-中英文对照 室内设计-interior design 室内设计师- interior designer 建筑-architecture 建筑师-architect 景观-landscape 家具-furniture 灯光-lighting 照明-illumination 家居设计-residential design 商业设计-commercial design 软装-FF&E（furniture fixture and equipment) 人体工程学-ergonomics 空间-space 精品酒店-boutique hotel 草图-draft or sketch 规格-specification 汇报或讲解-presentation 渲染或着色-rendering 透视-perspective 规范-code 对称-symmetry 不对称-asymmetry 轴线-axis 空间篇 住宅类 客厅，起居室—living room 餐厅-dinning room 玄关-foyer 卧室-bedroom 主卧-master bedroom 次卧-second bedroom 客卧-guest bedroom 厨房-Kitchen 厨岛kitchen island 书房-study room 衣帽间-cloakroom 卫生间-bathroom , toilet , bath 储藏室-storage 楼梯-stair 阳台-balcony 花园-garden 露台-patio 商业类 1办公类 接待处- reception 候客区-waiting Area or lounge 会议室（小型的）-meeting room or seminar 会议室（大型的）-conference room 办公室- office 经理办公室manager office 开放式的工作区-work area 多功能室-multi-function room 2酒店类 入口-entrance 出口-exit 大堂-lobby 前厅-vestibule 过道-corridor 休闲区,等候区-lounge 宴会厅-ballroom 客房-guestroom 套间-suite 行政套房-executive suite 总统套房-presidential suite 健身中心—fitness center or gym 瑜伽-yoga 泳池-swimming pool Spa 咖啡厅-cafe 酒吧-bar 餐厅-restaurant 备餐-pantry 电梯-elevation or lift 卫生间-restroom 男-men's 女women's 影院-cinema 商务中心-business center 行李间-luggage store 盥洗室-lavatory 3其他类 天花-ceiling 长廊-pavilion 零售店-retail store 大厅(堂）-hall 展览-gallery
学生成绩报告单模板
范塘小学学生成绩报告单 姓名 申诗龄 学校 范塘小学 班别 三年级 学 科 科目 品德与生活 语文 数学 英语 音乐 体育 美术 成绩 寒假寄 语 当冬日的阳光普照大地的时候，当春节的脚步渐渐临近的时候，寒假已悄然而至，我们将暂时分开一段时间，你们让老师多了一份牵挂，为了让你们拥有一个愉快而有意义的寒假，度过一个文明、祥和、欢乐的春节，老师在这里要给你们一些温馨提示哟! 请大家记住我们的约定： 1、认真完成寒假作业，注意书写要认真规范。 2、合理安排自己的休息时间，每天早睡早起，不要做一只赖床的“小懒虫”哟! 3、坚持锻炼身体，每天坚持2个小时的体育锻炼到户外活动。 4、放假在家注意安全，要远离火、开水、注意用电安全;不要燃放烟花 班主任评语 班主任： 通知 按上级通知，本学期定于公历2018年2月7日开始放寒假，下学期定于农历正月十六日上午报到，下午上课。来校时，务必带齐寒假作业。
港口中学学生成绩报告单 姓名 汪洁 学校 港口中学 班别 五年级 学 科 科目 品德与生活 语文 数学 英语 音乐 体育 美术 成绩 89 81 89 85 90 90 95 寒假寄 语 当冬日的阳光普照大地的时候，当春节的脚步渐渐临近的时候，寒假已悄然而至，我们将暂时分开一段时间，你们让老师多了一份牵挂，为了让你们拥有一个愉快而有意义的寒假，度过一个文明、祥和、欢乐的春节，老师在这里要给你们一些温馨提示哟! 请大家记住我们的约定： 1、认真完成寒假作业，注意书写要认真规范。 2、合理安排自己的休息时间，每天早睡早起，不要做一只赖床的“小懒虫”哟! 3、坚持锻炼身体，每天坚持2个小时的体育锻炼到户外活动。 4、放假在家注意安全，要远离火、开水、注意用电安全;不要燃放烟花 班主任评语 你为人正直诚恳，尊敬老师，团结同学，关心班集体，待人有礼，能认真听从老师的教导。学习刻苦努力，成绩优良。天才出自勤奋，希望你在新学期里严格要求自己，你的聪明加上勤奋好学才会令你成功。 班主任：汪立平
中英文论文对照格式
英文论文APA格式 英文论文一些格式要求与国内期刊有所不同。从学术的角度讲，它更加严谨和科学，并且方便电子系统检索和存档。 版面格式
表格 表格的题目格式与正文相同，靠左边，位于表格的上部。题目前加Table后跟数字，表示此文的第几个表格。 表格主体居中，边框粗细采用0.5磅；表格内文字采用Times New Roman，10磅。 举例： Table 1. The capitals, assets and revenue in listed banks
图表和图片 图表和图片的题目格式与正文相同，位于图表和图片的下部。题目前加Figure 后跟数字，表示此文的第几个图表。图表及题目都居中。只允许使用黑白图片和表格。 举例： Figure 1. The Trend of Economic Development 注：Figure与Table都不要缩写。 引用格式与参考文献 1. 在论文中的引用采取插入作者、年份和页数方式，如"Doe (2001, p.10) reported that …" or "This在论文中的引用采取作者和年份插入方式，如"Doe (2001, p.10) reported that …" or "This problem has been studied previously (Smith, 1958, pp.20-25)。文中插入的引用应该与文末参考文献相对应。 举例：Frankly speaking, it is just a simulating one made by the government, or a fake competition, directly speaking. (Gao, 2003, p.220). 2. 在文末参考文献中，姓前名后，姓与名之间以逗号分隔；如有两个作者，以and连接；如有三个或三个以上作者，前面的作者以逗号分隔，最后一个作者以and连接。 3. 参考文献中各项目以“点”分隔，最后以“点”结束。 4. 文末参考文献请按照以下格式：
室内设计 外文翻译 外文文献 英文文献 自然 简约—对室内设计现象分析
室内设计外文翻译外文文献英文文献自然简约—对 室内设计现象分析 附件2:外文原文 Natural simplicity - on interior design Analysis Abstract: The natural, simple interior design show is a way of life, it allows us closer to nature, more emphasis on functionality, more concerned about life itself. create a poetic space. Keywords: minimalism; space; grade; interior design; feeling Ancient times, Chinese wooden framework architecture of ancient India, the Orient, Europe, building caves in ancient Greece, ancient Rome and so on decorative stone building closely integrated with the components, with the main building, however. dissolved into Europe in the early seventeenth century Baroque times and the mid-eighteenth century the Rococo era, began with the interior decoration of the main building separated from the main building external and internal fitting-out period in the use of the mismatch, thus leading to the main building and interior decoration of the separation, in the construction of the French court architecture and aristocratic mansion, the new occupation "decorative artisan" was born, the building's internal frequency continuous modification, fixed the main building, the replacement building, "clothing" the time has come. Baroque-style architecture of
实验报告封面
(此文档为word格式，下载后您可任意编辑修改！) 建筑材料试验报告 专业： 班级： 学号： 姓名： 成绩：
河南城建学院 土木工程与材料工程系建材实验 序言 实验报告是实验者最后交出的成果，是对实验资料的总结，因此应按照要求（具体见实验规则）及时认真地书写。 本报告册中带*的项目专科生不作要求。实验报告中的“问题分析”项目主要包括本实验误差产生的原因分析（误差过大时才书写）、在实验中所观察到的异常现象及其产生原因分析等内容。主义论据要清晰明了，没有问题则不要勉强。 附：实验报告评分标准
建材实验室 2010年11月 目录 1、材料密度试验…………………………………………… （1） 2、材料表观密度试验…………………………………… （4）
3、材料堆积密度试 验 (7) 4、水泥细度试验…………………………………………… (10) 5、砂的筛分析试验………………………………………… （13) 6、混凝土拌合物试验……………………………………… （17） 7、混凝土抗压强度试验…………………………………… (21) 8、混凝土抗折强度试验…………………………………… (24) 9、混凝土劈裂抗拉强度试验……………………………… (27) 10、水泥胶砂试件成型试验………………………………… (30) 11、水泥胶砂强度试验……………………………………… (32) 12、沥青试样制备试验………………………………………
(36) 13、沥青针入度试验………………………………………… (38) 14、沥青延度试验…………………………………………… (41) 15、沥青软化试验…………………………………………… (44) 16、钢筋试验………………………………………………… （47） 17、新拌筑砂浆试验………………………………………… (52) 18、砂浆抗压强度试验……………………………………… (55) 19、普通粘土砖试验………………………………………… (59) 20、水泥净浆的SEM实验（设计 性）…………………………… 21、水泥稠度凝结时间安定性（设计 性）…………………………
3英文文献及翻译格式示例
哈尔滨工业大学毕业设计（论文） 英文原文（原文也可以直接将PDF版打印） ASSESSING CREDIT OR DETERMINING QUANTITY? THE EVOLVING ROLE OF RATING AGENCIES Lynnette D. Purda* This version: April 21, 2011 Abstract Over the past ten years, credit rating agencies have come under intense criticism from both practitioners and academics, first for their failure to identify problems resulting in bankruptcies at Enron and Worldcom and second for providing overly optimistic ratings for structured finance products. While many investors question the value of rating agencies in light of these criticisms, they have proven remarkably resilient. This paper provides a brief background on how rating agencies secured competitive advantages in evaluating credit quality. It then reviews the empirical evidence on the information content of ratings given these advantages. I argue that the information content of ratings stems from two intertwined sources: 1) information related to credit quality and 2) information related to the firm’s ability to access debt. Based on this evidence, I suggest that the dominant role for ratings today is as a benchmark for financial contracting. In this way, ratings remain influential in establishing the supply and demand of debt securities. 译文 评级机构的发展的作用评估信用还是决定数量？ 本文：2011.4.21 摘要 在过去的十年，信用评级机构一直处于来自实践者和学者的激烈的批评中，首先他们未能发现问题，导致安然和世通破产；其次对结构性金融产品提供过于乐观的评级。虽然许多投资者因为这些批评对评级机构的价值提出了质疑，但他们仍然被证明是相当有活力的。这篇文章首先在评估机构如何在信用评级质量中获得竞争优势提供一个简单地背景介绍，然后考虑到这些优势回顾了一些信息内容方面的评级经验证据。个人认为信息内容的评级来自两种交织在一起（错综复杂）的来源：1）和信贷质量相关的信息；2)和公司获取债务资本能力相关的信息。以此为据，我建议当前评级的主导作用是作为基准的金融收缩。以这种方式，在建立债券的供应和需求方面评级仍然是有效的。 - -1
室内设计中英文翻译
毕业设计英文资料翻译 Translation of the English Documents for Graduation Design Interior Design Susan Yelavich Interior design embraces not only the decoration and furnishing of space, but also considerations of space planning, lighting, and programmatic issues pertaining to user behaviors, ranging from specific issues of accessibility to the nature of the activities to be conducted in the space. The hallmark of interior design today is a new elasticity in typologies, seen most dramatically in the domestication of commercial and public spaces. Interior design encompasses both the programmatic planning and physical treatment of interior space: the projection of its use and the nature of its furnishings and surfaces, that is, walls, floors, and ceilings. Interior design is distinguished from interior decoration in the scope of its purview. Decorators are primarily concerned with the selection of furnishings, while
实验报告册封面
河南省高等教育自学考试 实验报告册 机电一体化工程专业（本科） 《机电一体化系统设计》 助考院校：_______________ 考生姓名：_______________ 准考证号：_______________ 河南科技大学高等教育自学考试办公室 ______年_____月
注意事项 1、各助考单位可就近选择定点实验单位安排考生完成实验任务。定点实验单位必须根据自身实验条件，开出某一门课程的全部实验，并要求考生将这一门课程全部实验一次性全部完成。若定点实验单位不能开出课程全部实验，则考生必须另选其它定点单位完成这一门课程的实验。一门课程实验不允许考生跨单位分项完成，否则，实验成绩不予承认。 2、要求考生选择这一门课程至少3个实验，要求独立完成。 3、考生在实验前应认真预习实验指导书的有关内容，遵守实验操作规程，确保人身和设备安全，认真做好每一个实验，并独立完成实验报告，有问答题的实验，必须认真回答，不能空项。填写实验报告，必须使用黑或兰黑钢笔（插图可用铅笔），要求字迹整洁。 4、实验指导教师应按指导书要求，指导考生完成试验并认真批阅实验报告。确定初评成绩。填写您所负责的某一门课程的实验报告评分栏，加盖实验单位印章。 5、考生做实验时，应持本报告册。完成实验后由考绩所在助学单位统一送到主考学校。考核合格者的发给“实验环节考核合格证书”，作为考生取得毕业资格的依据之一。
目录 一、实验一：三相异步电动机正反转控制―――――――――1 二、实验二：PLC控制三相异步电动机变频调速――――――4 三、实验报告评分栏――――――――――――――――――7
小学生成绩报告单评语
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学士学位证书及毕业证英文翻译模板
学士学位证书及毕业证英文翻译模板 BACHELOR’S DE GREE CERTIFICATE This is to certify that Ms. Wang Danli, born in October 1977, has studied in the Department of Law, xxx University with a specialty of Law from September 1996 to June 2000. Upon completing and passing all the required courses of the 4-year undergraduate program, she is granted graduation. In accordance with the academic degree act of the People’s Republic of China, the aforesaid student is awarded the Bachelor’s Degree in Law. xxx Chairman of Degree Appraising Committee of xx University June 30, 2000 Certificate No.: 103354003888 [ Last edited by rachel4176 on 2005-6-22 at 21:14 ] 毕业证书翻译模板 DIPLOMA This is to certify that Ms. Wang Lan, born on February 29, 1980, has studied in the Department of Foreign Languages,xxxUniversity with a specialty of English from September 1997 to June 2000. Upon completing and passing all the required courses of the 4-year undergraduate program, she is granted graduation. xx President of xx University Registration No.: 298168015 Date Issued: June 30, 2000
室内设计英语词汇中英文翻译
客厅 Livingroom 卧室 Bedroom 书房 Study 阁楼 Loft 楼梯 Stair 楼梯间 Stir Well 玄关 Entrance 卫生间 Bathromm 厨房 Kitchen ground plan 平面图 floor, storey 层 ground floor 第一层 (美作:first floor) flat 套 (美作:apartment) stair well 楼梯间 lift shaft (美作:elevator shaft) fire escape 防火梯 staircase 楼梯 goods lift 公务电梯 (美作:freight elevator) central heating 暖气 ventilation shaft 通风井 air conditioning 空调 air-conditioned 带空调的 flooring (一块)地板 floorboard 地板(总称) parquet 木条地板 herringbone parquet 人字形木条地板 tile 瓷砖 terrazzo 磨石子地 wall 墙 main wall 承重墙 partition wall 隔断墙 plastering 抹灰 skirting board 壁脚板 to whitewash 粉刷 facade 建筑物正面 window 窗 basement 地下室 penthouse 遮檐,披屋 attic, garret 阁楼 kitchen 厨房 dining room 饭厅 living room 起居室 lounge 吸烟室,大厅 bathroom 浴室 toilet 卫生间chimney 烟囱 fireplace 壁炉 gutter 排水沟 drainpipe 雨水管,落水管 ceiling 天花板 flat roof, roof garden 屋顶平台,屋顶花园 roof 屋瓦顶 tile, roof tile 瓦 sand 沙 cement 水泥 mortar 灰泥 plaster 石膏 concrete 混凝土 reinforced concrete, prestressed concrete 钢筋混凝土 gravel 碎石 brick 砖 slate 石板 marble 大理石 beam 梁,木梁 girder 钢梁 corrugated iron 波状钢 timber 木料,木材 pipes 钢管 wiring 电器设备 promoter 创办人 architect 建筑师 quantity surveyor 施工技术员 draftsman 绘图员 civil engineer 道路工程师 builder 建筑工人 foreman 工头 master builder 营造商,建筑工程队队长 (master) bricklayer 泥瓦匠,砌砖工匠 hodman, hod carrier 小工 plasterer 抹灰工 welder 焊工 joiner 工匠 electrician 电工 glazier 玻璃工匠 plumber 管道技工 plumber's mate 管道工 painter, decorator 油漆工 crane driver 吊车司机
学生成绩报告单及评语
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室内设计外文翻译
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地质雷达实验报告封面报告
地质雷达实验报告封面 报告 Document number：PBGCG-0857-BTDO-0089-PTT1998
地质雷达实验报告 成绩： 系别：资源勘查与土木工程系 专业班级： 姓名： 学号： 指导教师： 年月日
实验项目名称：地质雷达的操作及应用 同组学生姓名： 实验地点：结构检测实验室91110 实验日期：年月日 实验目的 （1）了解地质雷达基本构造、性能和工作原理。 （2）掌握地质雷达的操作步骤和使用方法。 实验原理及方法 通过发射天线向地下发射宽频带高频电磁波。在传播过程中，当遇到存在电性差异的地下介质或目标体时，雷达波会发生反射返回地面，并由接收天线接收，并以波或图像的形式，存储在电脑中。 仪器设备 OKO-2俄罗斯地质雷达。
实验步骤 （1）连好数据线； （2）打开主机和天线上的电源开关； （3）运行采集软件； （4）设置参数； （5）数据采集并保存数据； （6）关机、拆线。 数据处理 主要包括两个方面：即增益和滤波。增益的目的是放大深部信号的增幅，使较弱的信号能被识别，滤波的种类很多，一般包括中值滤波、平均值滤波、带通滤波和巴特沃斯带通滤波等等。 注意事项 在运用雷达过程中，须掌握雷达工作的三个重要参数：环境电导率、介电常数和探测频率。 环境电导率σ是表征介质导电能力的参数，它决定了电磁波在介质中的穿透深度，其穿透深度随电导率的增加而减小，当介质的电导率σ>10-2S/m时，电磁波衰减极大，难于传播，雷达方法不宜使用，如：湿粘土、湿页岩、海水、海水冰、湿沃土、金属物等。
介电常数是影响应用效果的另一个重要因素，它决定了高频电磁波在介质中的传播速度，并且反射信号的强弱也取决于介电常数的差异。电磁波在介质中的传播速度可采用下式近似考虑： r C V ε≈ 式中： C ─ 电磁波在真空中的传播速度，C =ns （光速）， r ε─ 介质的相对介电常数。 介质的介电常数主要受介质的含水量以及孔隙率的影响，相对介电常数与水含量的关系曲线，相对介电常数的范围为：1（空气）~81（水），多数干燥的地下介质，其相对介电常数值均小于10。 探测频率不但是制约探测深度的一个关键因素，同时也决定了探测的分辨率；探测频率越高，探测深度越浅，探测的垂直分辨率和水平分辨率越高。高频 电磁波在传播过程中发生衰减，其衰减的程度随电磁波频率的增加而增加，这也是造成探测频率越高，探测深度越浅的原因。因此，在实际工作时，必须根据目标体的探测深度选用合理的探测频率。 附图（不少于6张图片）
英文文献及中文翻译撰写格式
关于毕业设计说明书（论文）英文文献及中文翻译撰写格式 为提高我校毕业生毕业设计说明书（毕业论文）的撰写质量，做到毕业设计说明书（毕业论文）在内容和格式上的统一和规范，特规定如下: 一、装订顺序 论文（设计说明书）英文文献及中文翻译内容一般应由3个部分组成，严格按以下顺序装订。 1、封面 2、中文翻译 3、英文文献（原文） 二、书写格式要求 1、毕业设计（论文）英文文献及中文翻译分毕业设计说明书英文文献及中文翻译和毕业论文英文文献及中文翻译两种，所有出现相关字样之处请根据具体情况选择“毕业设计说明书” 或“毕业论文”字样。 2、毕业设计说明书（毕业论文）英文文献及中文翻译中的中文翻译用Word 软件编辑，英文文献用原文，一律打印在A4幅面白纸上，单面打印。 3、毕业设计说明书（毕业论文）英文文献及中文翻译的上边距:30mm；下边距:25mm；左边距:3Omm；右边距:2Omm；行间距1.5倍行距。 4、中文翻译页眉的文字为“中北大学2019届毕业设计说明书” 或“中北大学××××届毕业论文”，用小四号黑体字，页眉线的上边距为25mm；页脚的下边距为18mm。 5、中文翻译正文用小四号宋体，每章的大标题用小三号黑体，加粗，留出上下间距为：段前0.5行，段后0.5行；二级标题用小四号黑体，加粗；其余小标题用小四号黑体，不加粗。 6、文中的图、表、附注、公式一律采用阿拉伯数字分章编号。如图1.2，表2.3，附注3.2或式4.3。 7、图表应认真设计和绘制,不得徒手勾画。表格与插图中的文字一律用5号宋体。
每一插图和表格应有明确简短的图表名，图名置于图之下，表名置于表之上，图表号与图表名之间空一格。插图和表格应安排在正文中第一次提及该图表的文字的下方。当插图或表格不能安排在该页时，应安排在该页的下一页。 图表居中放置，表尽量采用三线表。每个表应尽量放在一页内，如有困难，要加“续表X.X”字样，并有标题栏。 图、表中若有附注时，附注各项的序号一律用阿拉伯数字加圆括号顺序排，如:注①。附注写在图、表的下方。 文中公式的编号用圆括号括起写在右边行末顶格，其间不加虚线。 8、文中所用的物理量和单位及符号一律采用国家标准，可参见国家标准《量和单位》(GB3100~3102-93)。 9、文中章节编号可参照《中华人民共和国国家标准文献著录总则》。