ICHQ7(中英文)

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH H ARMONISED T RIPARTITE G UIDELINE

G OOD M ANUFACTURING P RACTICE G UIDE FOR A CTIVE P HARMACEUTICAL

I NGREDIENTS

Q7

Current Step 4 version

dated 10 November 2000

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

中英文对照

Q7

Current Step 4 version

G OOD M ANUFACTURING P RACTICE G UIDE FOR A CTIVE P HARMACEUTICAL

I NGREDIENTS

ICH Harmonised Tripartite Guideline

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH

Table of Contents 目录

1. INTRODUCTION 1. 前言

1.1 Objective 1.1 目的

1.2 Regulatory Applicability 1.2 法规的适用性

1.3 Scope 1.3 范围

2. QUALITY MANAGEMENT 2.质量管理

2.1 Principles 2.1 总则

2.2 Responsibilities of the Quality Unit(s) 2.2 质量部门的责任

2.3 Responsibility for Production Activities 2.3 生产的职责

2.4 Internal Audits (Self Inspection) 2.4 内部审计（自检）

2.5 Product Quality Review 2.5 产品质量回顾

3. PERSONNEL 3. 人员

3.1 Personnel Qualifications 3.1人员资格

3.2 Personnel Hygiene 3.2 个人卫生

3.3 Consultants 3.3 顾问

4. BUILDINGS AND FACILITIES 4. 建筑和设施

4.1 Design and Construction 4.1 设计和建造

4.2 Utilities 4.2 公用设施

4.3 Water 4.3 水

4.4 Containment 4.4 特殊限制

4.5 Lighting 4.5 照明

4.6 Sewage and Refuse 4.6 污物和废弃物

4.7 Sanitation and Maintenance 4.7 卫生和维护

5. PROCESS EQUIPMENT 5. 工艺设备

5.1 Design and Construction 5.1 设计和建造

5.2 Equipment Maintenance and Cleaning 5.2 设备维护和清洁

5.3 Calibration 5.3 校验

5.4 Computerized Systems 5.4 计算机控制系统

6. DOCUMENTATION AND RECORDS 6. 文件和记录

6.1 Documentation System and Specifications 6.1 文件系统和质量标准

6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录

6.3 Records of Raw Materials,Intermediates, 6.3 原料、中间体、原料药的标签和包装材料的记录

API Labeling and Packaging Materials

6.4 Master Production Instructions 6.4 主生产指令（主生产和控制记录）

(Master Production and Control Records)

6.5 Batch Production Records 6.5 批生产记录（批生产和控制记录）

(BatchProduction and Control Records)

6.6 Laboratory Control Records 6.6 实验室控制记录

6.7 Batch Production Record Re view 6.7 批生产记录审核

7. MATERIALS MANAGEMENT 7. 物料管理

7.1 General Controls 7.1 一般要求

7.2 Receipt and Quarantine 7.2 接收和待验

7.3 Sampling and Testing of Incoming Production Materials 7.3 来料的取样与检测

7.4 Storage 7.4 储存

7.5 Re-evaluation 7.5 再评价

8. PRODUCTION AND IN-PROCESS CONTROLS 8. 生产管理和生产过程控制

8.1 Production Operations 8.1 生产管理

8.2 Time Limits 8.2 时限

8.3 In-process Sampling and Controls 8.3 生产过程中的取样和控制

8.4 Blending Batches of Intermediates or APIs 8.4 中间体或原料药的混批

8.5 Contamination Control 8.5 污染控制

9. PACKAGING AND IDENTIFICATION 9. 原料药和中间体的包装和贴签

LABELING OF APIs AND INTERMEDIATES

9.1 General 9.1 通则

9.2 Packaging Materials 9.2 包装材料

9.3 Label Issuance and Control 9.3 标签发放与管理

9.4 Packaging and Labeling Operations 9.4 包装和贴签管理

10. STORAGE AND DISTRIBUTION 10.储存和分发

10.1 Warehousing Procedures 10.1 入库程序

10.2 Distribution Procedures 10.2 分发程序

11. LABORATORY CONTROLS 11.实验室管理

11.1 General Controls 11.1通则

11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的检测

11.3 Validation of Analytical Procedures 11.3 分析方法的验证

11.4 Certificates of Analysis 11.4 检验报告

11.5 Stability Monitoring of APIs 11.5 原料药的稳定性考察

11.6 Expiry and Retest Dating 11.6 有效期和复验期

11.7 Reserve/Retention Samples 11.7 留样

12. VALIDATION 12.验证

12.1 Validation Policy 12.1 验证方针

12.2 Validation Documentation 12.2 验证文件

12.3 Qualification 12.3 确认

12.4 Approaches to Process Validation 12.4 工艺验证的方法

12.5 Process Validation Program 12.5 工艺验证的程序

12.6 Periodic Review of Validated Systems 12.6 对已验证的系统的定期回顾

12.7 Cleaning Validation 12.7 清洗验证

12.8 Validation of Analytical Methods 12.8 分析方法的验证

13. CHANGE CONTROL 13.变更控制

14. REJECTION AND RE-USE OF MATERIALS 14.物料的拒收和再利用

14.1 Rejection 14.1 拒收

14.2 Reprocessing 14.2 返工

14.3 Reworking 14.3 重新加工

14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收

14.5 Returns 14.5 退货

15. COMPLAINTS AND RECALLS 15.投诉与召回

16. CONTRACT MANUFACTURERS16.协议生产商（包括实验室）

(INCLUDING LABORATORIES)

17. AGENTS, BROKERS, TRADERS, DI STRIBUTORS, 17.代理商、经纪人、贸易商、经销商、重新包装者REPACKERS, AND RELABELLERS和重新贴签者

17.1 Applicability 17.1 适用性

17.2 Traceability of Distributed APIs and Intermediates 17.2 已分发的原料药和中间体的可追溯性

17.3 Quality Management 17.3 质量管理

17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4 原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5 稳定性

17.6 Transfer of Information 17.6 信息的传达

17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理

17.8 Handling of Returns 17.8 退货的处理

18. Specific Guidance for APIs Manufactured by Cell 18. 用细胞繁殖/发酵生产的原料药的特殊指南

Culture/Fermentation

18.1 General 18.1 总则

18.2 Cell Bank Maintenance and Record Keeping 18.2 细胞库的维护和记录的保存

18.3 Cell Culture/Fermentation 18.3 细胞繁殖/发酵

18.4 Harvesting, Isolation and Purification 18.4 收取、分离和精制

18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤

19. APIs for Use in Clinical Trials 19. 用于临床研究的原料药

19.1 General 19.1 总则

19.2 Quality 19.2 质量

19.3 Equipment and Facilities 19.3 设备和设施

19.4 Control of Raw Materials 19.4 原料的控制

19.5 Production 19.5 生产

19.6 Validation 19.6 验证

19.7 Changes 19.7 变更

19.8 Laboratory Controls 19.8 实验室控制

19.9 Documentation 19.9 文件

20. Glossary 20. 术语

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.

本文件旨在提供在适当的体系下为了控制生产原料药的质量而实施的药品生产质量管理规范（GMP）的指南。它也有助于帮助确保活性药物成分（APIs）符合其应有的质量和纯度要求。

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.

本指南中的“生产”定义为包括物料接收、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。

表 1: 本指南在原料药生产中的应用

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.

2.10 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.

2.11 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.

2.12 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 asingle 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, andregulatory 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.

2.51 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 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）

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.

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 ofmanufacture. 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:

●Receipt, identification, sampling, and quarantine of incoming materials, pending release or rejection

●Quarantine before release or rejection of intermediates and APIs

●Sampling of intermediates and APIs

●Holding rejected materials before further disposition (e.g., return, reprocessing or destruction)

●Storage of released materials

●Production operations

●Packaging and labeling operations

●Laboratory operations

4.14 以下活动应当有指定区域或其它控制系统：

●来料的接收、鉴别、取样和待验，等待放行或拒收；

●中间体和原料药放行或拒收前的待验；

●中间体和原料药的取样

●不合格物料处理（如退货、返工或销毁）前的贮存；

●已放行物料的贮存；

●生产操作；

●包装及贴标签操作；

●实验室操作。

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 beseparate 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

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。the laboratory and its operations do not adversely affect the production process,intermediate, or API.

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 itsintended 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.

4.31 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 cleaningprocedures 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 preventcross-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.

4.72 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 fitne ss 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:

●Assignment of responsibility for cleaningof equipment

●Cleaning schedules, including, whereappropriate, sanitizing schedules

● A complete description of the methods andmaterials, including dilution of cleaningagents used to clean equipment

●When appropriate, instructions for disassembling and reassembling eacharticle of equipment to ensure proper cleaning

●Instructions for the removal or obliteration of previous batch identification

●Instructions for the protection of clean equipment from contamination prior to use

●Inspection of equipment for cleanliness immediately before use, if practical

●Establishing the maximum time that may elapse between the completion of processing and equipment cleaning, when appropriate

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：

●设备清洗职责分配；

●清洗计划，必要时包括消毒计划；

●方法和材料的详尽描述，包括用于清洗设备的清洗剂的稀释方法；

●为确保正确的清洗，根据具体情况还应当包括包装设备拆卸和安装的方法；

●拿走或抹掉上一批的标识；

●使用前防止已清洁的设备被污染；

●如果可行，使用前对设备进行检查；

●根据情况，规定生产结束和清洗之间允许的最大时间间隔。

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 calibrationcriteria 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 Specifications6.1 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、控制记录和销售记录）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 PackagingMaterials

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 identific ation number; the number allocated on receipt;and the date of receipt

●The results of any test or examination preformed and the conclusions derived from this

●Records tracing the use of materials

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；

●所进行的任何测试或检查结果，以及由此得出的结论；

●跟踪物料使用的记录；

●Documentation of the examination and review of API labeling and packaging materials for conformity with established specifications

●The final decision regarding rejected raw materials, intermediates, or API labeling and packaging materials

●检查和审核原料药的标签和包装材料与规定标准符合度的证明文件；

●拒收原料、中间体或原料药的标签和包装材料的最终决定。

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。

6.41 Master production instructions should include:

●The name of the intermediate or API being manufactured and an identifying document reference code, if applicable

● A complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics

●An accurate statement of the quantity or ratio of each raw material or intermediate to be used, including the unit of measure. Where the quantity is not fixed, the calculation for each batch size or rate of production should be included. Variations to quantities should be included where they are justified

●The production location and major production equipment to be used

●Detailed production instructions, including the:

- sequences to be followed

- ranges of process parameters to be used

- sampling instructions and in-process controls with their acceptance criteria,where appropriate

- time limits for completion of individual processing steps and/or the total process, where appropriate

- expected yield ranges at appropriate phases of processing or time

●Where appropriate, special notations and precautions to be followed, or cross-references to these

●The instructions for storage of the intermediate or API to ensure its suitability for use, including the labeling and packaging materials and special storage conditions with time limits, where appropriate.

6.41 生产工艺规程应当包括：

●要生产的中间体或原料药的名称，如有可能，写明文件编号；

●完整地列出原料和中间体的足以区分任何质量特性的名称或代码；

●准确说明所用的每种原料或中间体的投料量或投料比，包括计量单位。如果投料量不是固定的，应当写明每批的批量或产率的计算方法。还应当包括经证明是合理的量的偏差；

●生产地点及使用的主要设备；

●详细的生产规程，包括：

- 操作顺序，

- 工艺参数的范围，

- 取样方法，过程控制及其认可标准，

- 某些情况下，要说明完成某一工序和/或整个工艺过程的时间，

- 在某一工艺阶段或时间的预期产率。

●根据情况，写明注意事项、要遵循的预防措施，或它们的相互参照；

●中间体或原料药的适宜贮存规定，包括标签、包装材料，某些情况下写明特殊的贮存条件、时间限制，以确保其使用。

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。

6.52 Documentation of completion of each significant step in the batch production records(batch production and control records) should include:

6.52 在批生产记录（批生产记录和控制记录）中提供每一重要步骤完成的证明，应当包括：

●Dates, and when appropriate, times

●Identify of major equipment (e.g., reactors,driers, mills, etc.) used

●Specific identification of each batch,including weights, measures, and batch numbers of raw materials, intermediates, or

any reprocessed materials used during manufacturing

●Actual results recorded for critical processparameters

●Any sampling performed

●Signatures of the persons performing and directly supervising or checking each critical step in the operation

●In-process and laboratory test results

●Actual yield at appropriate phases or times

●Description of packaging and label for intermediate or API

●Representative label of API or intermediate if made commercially available

●Any deviation noted, its evaluation,investigation conducted (if appropriate) or reference to that investigation if stored separately ●Results of release testing

●日期，某些情况下还有时间；

●主要设备（如反应釜，干燥器，磨粉机等）的标识；

●每一批的识别特征，包括原料、中间体或任何用于生产的返工物料的重量、计量单位、批号；

●记录关键工艺参数的实际值；

●取样；

●每个关键步骤的操作者和直接指导者或检查者的签名；

●过程控制和实验室的测试结果；

●适当阶段或时间的实际产率；

●中间体或原料药的包装材料和标签的描述；

●原料药或中间体的商业标签的样张；

●发现的任何偏差，进行的评估、调查（视情况而定），和索引到单独存放的调查报告；

●放行测试的结果。

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。

6.61 Complete records should also be maintained for:

●Any modifications to an established analytical method

●Periodic calibration of laboratory instruments, apparatus, gauges, and recording devices

●All stability testing performed on APIs

●Out-of-specification (OOS) investigations

6.61 应当保存完整的下列记录：

●既定的分析方法的任何修改；

●实验室仪器、设备、仪表和记录装置的定期校验；

●原料药的所有稳定性测试；

●不合格的调查。

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.

6.72 在批放行前，所有偏差，调查和不合格报告都应当作为批记录的一部分进行审核。

6.73 The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company.

6.73 质量部门可将发放中间体的职责和权力委派给生产部门，运往生产商控制范围以外的中间体除外。

7. MATERIALS MANAGEMENT 7. 物料管理

7.1 General Controls 7.1 控制通则

7.10 There should be written procedures describing the receipt, identification,quarantine, storage, handling, sampling, testing,and

approval or rejection of materials.

7.10 应当有书面程序阐明物料的接收、鉴别、待验、贮存、搬运、取样、测试和批准或拒收。

7.11 Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.

7.11 原料药和/或中间体生产商应当有对关键原料供应商的评估系统。

7.12 Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the quality unit(s). 7.12 应当根据已确定的规格从经过质量部门核准的一个或多个供应商处购买物料。

7.13 If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer.

7.13 如果关键物料的供应商不是该物料的生产商，原料药或中间体的生产商应当获知该物料生产商的名称和地址。

7.14 Changing the source of supply of critical raw materials should be treated according to Section 13, Change Control.

7.14 关键原料的供应商的变更应当参照第13 章“变更控制”进行。

7.2 Receipt and Quarantine 7.2 接收和待验

7.20 Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labeling (including correlation between the name used by the supplier and the in-house name, if these are different), container damage,broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined, or tested, as appropriate, and released for use.

7.20 一旦收到物料而尚未验收，应当目测检查物料每个或每组包装容器的标签是否正确（包括如果供应商所用名称与内部使用的名称不一致，应当检查其相互关系）、容器是否损坏、密封处和开启证据有无破裂或污染。物料应当存放的待验区，直至它们被取样、检查或酌情测试，并放行使用。

7.21 Before incoming materials are mixed with existing stocks (e.g., solvents or stocks in silos),they should be identified as correct, tested, if appropriate, and released. Procedures should be available to prevent discharging incoming materials wrongly into the existing stock.

7.21 在进厂的物料与现有的库存（如储仓中的溶剂或货物）混合之前，应当确认货是否对、必要时进行测试并放行。应当有程序来防止把来料错放到现有的库存中。

7.22 If bulk deliveries are made in nondedicated tankers, there should be assurance of no cross-contamination from the tanker. Means of providing this assurance could include one or more of the following:

●certificate of cleaning

●testing for trace impurities

●audit of the supplier

7.22 对于非专用槽车运送的大宗物料，应当确保没有来自槽车的交叉污染。可用以下的一种或几种方法来提供这种保证：

●清洁证书

●残留物的测试

●供应商审计

7.23 Large storage containers and their attendant manifolds, filling, and discharge lines should be appropriately identified.

7.23 大的储存容器及其随附的管路、填充和排放管都应当适当标明。

7.24 Each container or grouping of containers(batches) of materials should be assigned and identified with a distinctive code, batch, or receipt number. This number should be used in recording the disposition of each batch. A system should be in place to identify the status of each batch.

7.24 每个或每组物料容器（几批）的物料都应当指定并标上编号、批号或接收号。此号码应当用于记录每批的处置情况。应当有一个识别每批状态的系统。

7.3 Sampling and Testing of Incoming Production Materials

7.3 进厂物料的取样与测试

7.30 At least one test to verify the identity of each batch of material should be conducted,with the exception of the materials described below. A supplier’s certificate of analysis can be used in place of performing other tests,provided that the manufacturer has a system in place to evaluate suppliers.

7.30 除了7.32 中指出的物料，对于每批物料至少要做一个鉴别试验。在生产商对供应商有一套审计体系的前提下，供应商的分析报告可以用来替代其他项目的测试。

7.31 Supplier approval should include an evaluation that provides adequate evidence(e.g., past quality history) that the manufacturer can consistently provide material meeting specifications. Complete analyses should be conducted on at least three batches before reducing in-house testing. However, as a minimum, a complete analysis should be performed at appropriate intervals and compared with the certificates of analysis.Reliability of certificates of analysis should be checked at regular intervals.

7.31 对供应商的核准应当包括一次评估，提供足够的证据（如过去的质量记录）证明该生产商始终都能提供符合质量标准的物料。在减少内部测试之前至少应当对三批物料作全检。然而，最低限度每隔一定时间应当进行一次全检，并与分析报告进行比较。分析报告的可靠性应当定期进行检查。

7.32 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer’s certificate of analysis is obtained, showing that these raw materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers should

help in establishing the identity of these materials. The lack of on-site testing for these materials should be justified and documented.

7.32 工艺助剂、有害或剧毒的原料、其它特殊物料、或转移到公司控制范围内的另一个部门的物料不用测试，前提是能取得生产商的分析报告，证明这些原料符合规定的质量标准。对容器、标签和批号记录进行目测检查应当有助于鉴别这些原料。对这些物料不作现场测试应当说明理由，并用文件证明。

7.33 Samples should be representative of the batch of material from which they are taken.Sampling methods should specify the number of containers to be sampled, which part of the container to sample, and the amount of material to be taken from each container. The number of containers to sample and the sample size should be based on a sampling plan that takes into consideration the criticality of the material,material variability, past quality history of the supplier, and the quality needed for analysis.

7.33 取样应当能代表被取的那批物料。取样方法应当规定：取样的容器数，取样部位，每个容器的取样量。取样容器数和取样量应当根据取样方案来决定。取样方案的制定要综合考虑物料的重要程度、变异性、供应商过去的质量情况，以及分析需用量。

7.34 Sampling should be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials.

7.34 应当在规定的地点，用规定的方法取样，以避免取样的物料被污染，或污染其它物料。

7.35 Containers from which samples are withdrawn should be opened carefully and subsequently reclosed. They should be marked to indicate that a sample has been taken.

7.35 被取样的容器应当小心开启，随后重新密封。这些容器应当做标记表明样品已抽取。

7.4 Storage 7.4 储存

7.40 Materials should be handled and stored in a manner to prevent degradation,contamination, and cross-contamination.

7.40 物料的搬运和贮存应当防止降解、污染和交叉污染。

7.41 Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate, suitably spaced to permit cleaning and inspection.

7.41 纤维板桶、袋子或盒装物料应当离地贮存，并根据情况留出适当空间便于清洁和检查。

7.42 Materials should be stored under conditions and for a period that have no adverse effect on their quality, and should normally be controlled so that the oldest stock is used first.

7.42 物料应当在对其质量没有不良影响的条件下和时限内贮存，而且通常应当加以控制，做到先进先出。

7.43 Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use.

7.43 某些装在适当容器中的物料可以存放在室外，只要识别标签保持清晰，而且容器在开启和使用前进行适当清洁。7.44 Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorized use in manufacturing.

7.44 不合格物料应当做标识，并用隔离系统控制，已防止未经许可而用于生产。

7.5 Re-evaluation 7.5 重新评估

7.50 Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after prolonged storage or exposure to heat or humidity).

7.50 应当根据情况对物料进行重新评估以便确定其使用的适合性（例如长期存放或暴露于热或潮湿的环境中）。

8. PRODUCTION AND IN-PROCESS CONTROLS

8. 生产和过程控制

8.1 Production Operations 8.1 生产操作

8.10 Raw materials for intermediate and API manufacturing should be weighed or measured under appropriate conditions that do not affect their suitability for use. Weighing and measuring devices should be of suitable accuracy for the intended use.

8.10 用于生产中间体和原料药的原料应当在适宜的条件下称重或测量，以便不影响其使用的适合性。称重和测量装置应当有适合于其用途的精度。

8.11 If a material is subdivided for later use in production operations, the container receiving the material should be suitable and should be so identified that the following information is available:

●Material name and/or item code

●Receiving or control number

●Weight or measure of material in the new container

●Re-evaluation or retest date if appropriate

8.11 如果某物料分出一部分留待以后的生产操作中使用，应当用适合的容器来盛装该物料，并应当标明下列信息：

●物料的名称和/或货号；

●接收号或控制号；

●新容器中物料的重量或计量；

●如有必要，标明复验期。

8.12 Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.

8.12 关键的称重、测量或分装操作应当有人作证或接受相应的控制。使用前，生产人员应当确认该物料是要生产的中间体或原料药的批记录中指定的。

8.13 Other critical activities should be witnessed or subjected to an equivalent control.

8.13 其它关键活动应当有人作证或接受相应的控制。

8.14 Actual yields should be compared with expected yields at designated steps in the production process. Expected yields with appropriate ranges should be established based on previous laboratory, pilot scale, or manufacturing data. Deviations in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.

8.14 在生产过程中的指定步骤，实际收率应当与预计的收率作比较。具有合适范围的预计收率应当根据以前的实验室、中试规模或生产的数据来确定。应当调查与关键工艺步骤有关的收率偏差，以确定其对相关批号最终质量的影响或潜在影响。

8.15 Any deviation should be documented and explained. Any critical deviation should be investigated.

8.15 任何偏差都应当记录，并作解释。任何关键的偏差应当作调查。

8.16 The processing status of major units of equipment should be indicated either on the individual units of equipment or by appropriate documentation, computer control systems, or alternative means.

8.16 应当标明主要设备的生产状态，可以标在每个设备上，或者用文件、计算机控制系统或其它替代的方法。

8.17 Materials to be reprocessed or reworked should be appropriately controlled to prevent unauthorized use.

8.17 对需要进行返工或重新加工的物料应当适当地加以控制，防止未经许可就使用。

8.2 Time Limits 8.2 时限

8.20 If time limits are specified in the master production instruction (see 6.40), these time limits should be met to ensure the quality of intermediates or APIs. Deviations should be documented and evaluated. Time limits may be inappropriate when processing to a target value (e.g., pH adjustment, hydrogenation, drying to predetermined specification) because completion of reactions or processing steps are determined by in-process sampling and testing.

8.20 如果生产工艺规程（见6.40）中规定了时限，应当遵守这些时限，以保证中间体和原料药的质量。所有偏差都要有记录并解释原因。在加工到一个目标值时（例如，调节pH、氢化、干燥到预定标准），时限可能就不合适了，因为反应或加工步骤的完成是取决于过程中的取样和测试的。

8.21 Intermediates held for further processing should be stored under appropriate conditions to ensure their suitability for use.

8.21 留作进一步加工的中间体应当在适宜的条件下储存，以保证其适宜于使用。

8.3 In-process Sampling and Controls 8.3 工序间的取样和控制

8.30 Written procedures should be established to monitor the progress and control the performance of processing steps that cause variability in the quality characteristics of intermediates and APIs. In-process controls and their acceptance criteria should be defined based on the information gained during the developmental stage or from historical data.

8.30 应当制定书面程序来监测会造成中间体和原料药质量特性变异的工艺步骤的进程，并控制其生产情况。工序间控制及其接受标准应当根据项目开发阶段或者以往的生产数据来确定。

8.31 The acceptance criteria and type and extent of testing can depend on the nature of theintermediate or API being manufactured, the reaction or process step being conducted, and the degree to which the process introduces variability in the product’s quality. Less stringent in-process controls may be appropriate in early processing steps, whereas tighter controls may be appropriate for later processing steps (e.g., isolation and purification steps).

8.31 综合考虑所生产中间体和原料药的特性，反应类型，该工序对产品质量影响的程度大小等因素来确定可接受的标准，检测类型和范围。前期生产的中间体控制标准可以松一些，越接近成品，中间控制的标准越严（如分离，纯化）。

8.32 Critical in-process controls (and critical process monitoring), including control points and methods, should be stated in writing and approved by the quality unit(s).

8.32 关键的中间控制（和工艺监测），包括控制点和方法，应当书面规定，并经质量部门批准。

8.33 In-process controls can be performed by qualified production department personnel and the process adjusted without prior quality unit(s) approval if the adjustments are made within pre-established limits approved by the quality unit(s). All test and results should be fully documented as part of the batch record.

8.33 中间控制可以由合格的生产部门的人员来进行，而调节的工艺可以事先未经质量部门批准，只要该调节在由质量部门批准的预先规定的限度以内。所有测试及结果都应当作为批记录的一部分全部归档。

8.34 Written procedures should describe the sampling methods for in-process materials,intermediates, and APIs. Sampling plans and procedures should be based on scientifically sound sampling practices.

8.34 应当制定书面程序，说明中间物料、中间体和原料药的取样方法。取样方案和程序应当基于科学合理的取样实践。8.35 In-process sampling should be conducted using procedures designed to prevent contamination of the sampled material and other intermediates or APIs. Procedures should be established to ensure the integrity of samples after collection.

8.35 工序间取样应当按能防止污染所取的样品、其它中间体或原料药的程序进行。应当制定保证样品收集后的完整性的程序。

8.36 Out-of-specification (OOS) investigations are not normally needed for in-process tests that are performed for the purpose of monitoring and/or adjusting the process.

8.36 生产操作中的正常监控过程和工艺调节过程中出现的超出标准的偏差（OOS），通常情况不需要调查。

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然后进入“中文（简体）输入法 - 输入法/非输入法切换”，取消“启用按键顺序”前的勾。一路都确定后推出设置。 再次进入设置，进入“在不同的输入语言之间切换”，把右边那个打上勾。确定后退出。

完美解决了无法使用ctrl+shift以及ctrl+space切换输入法的问题。

产品包装中英文(外贸)

Window box:纸盒，（上面有个透明胶片的窗口，类似于玩具包装） Blister card 吸塑罩 Blister pack:吸塑包装 Sleeve:套茼包装 Skin pack:单面吸卡包装（是产品放在一张卡上，然后用一张塑料膜吸在产品表面） Clip strip:挂条 color box彩盒 litho label:胶装标签 color paper and shrinking 彩标+收缩膜 brown box with picture 棕盒+贴彩图 double blister 气泡袋 hanger 内码标 hangtag 吊牌 head card 头卡（香港人叫横头卡，透明胶袋包装用，钉在袋头） jar 瓶装 PDQ display:paper window box 展示盒 plastic hook 吸盘 polybag/polybag with header 带头卡 PVC bag shrinking 收缩膜包装 pallet 托盘 瓦椤纸箱Corrugated Carton 木箱Wooden Case 板条箱Crate 木条箱Wooden 竹条箱Bamboo Crate 胶合板箱三层夹板箱3--Ply Plywood Case 镀锡铁皮胎木箱Tin Lined Wooden Case 塑料透明盒Plastic Transparency Box 苯乙烯盒Styrol袋Bag(Sack) 草袋Straw Bag 麻袋Gunny Bag／新麻袋New Gunny Bag 尼龙袋Nylon Bag 塑料袋Poly Bag 塑料编织袋Polywoven Bag 纤维袋Fibre Bag 玻璃纤维袋Glass Fibre Bag 玻璃纸袋Callophane Bag 防潮纸袋MoistureProof Pager Bag 乳胶袋子Emulsion Bag 锡箔袋Fresco Bag 特大袋Jumbo Bag 单层完整袋子Single Sound Bag 桶Drum 木桶Wooden Cask 大木桶Hogshead 小木桶Keg 粗腰桶(琵琶桶) Barrel 胶木桶Bakelite Drum 塑料桶Plastic Drum 镀锌铁桶Galvanized Iron Drum 镀锌闭口钢桶Galvanized Mouth Closed Steel Drum 镀锌开口钢桶Galvanized Mouth Opened Steel Drum 铝桶Aluminum Drum 麻布包Gunny Bale(Hessian Cloth Bag)

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方法3：点“开始→运行”，键入“msconfig”，单击“确定”或回车，运行“系统配置实用程序”，在“启动”里把“Ctfmon.exe”选中，单击“确定”，然后注销或重新启动应该就可以了。这是因为Ctfmon.exe控制Alternative User Input Text Processor (TIP)和Microsoft Office语言条，提供语音识别、手写识别、键盘、翻译和其它用户输入技术的支持。这个程序没有启动也会造成输入法图标不显示。 最后提示一下，没有输入法图标，用快捷键一样可以操作输入法。Ctrl+Space（空格键）是在中、英文输入法之间切换；按Ctrl+Shift 组合键可以依次显示系统安装的输入法。

中文操作说明书

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1.1.1 模式选择键 机床有四种工作模式“点动模式”，“手动模式”，“半自动模式”，“全自动模式” (见 Fig. 3, 从作到右) Fig. 3: 模式选择键 在点动模式下，动作的速度和压力都很低，螺杆不能动作；在手动模式下，手动点击各动作时，机床按页面上设置的参数进行动作；在半自动模式下，机床按设定的参数工作一个循环后，停止在模具打开的状态；在全自动模式下，机床按设定的参数进行循环工作。 提示： 机床正常运行时可通过切换到半自动模式来停机，这样比较方便。 1.1.2 机械手按钮 一个完整的机械手（料头夹持，机械手，可放置的机械手）可以通过一下相关的按钮进行机械手的开关和相应手动动作。 Fig. 4: 机械手按钮 通过不断点击“单级模式”，每一序列中设置的动作都可以一步步执行，按“归位”按钮可以开始一个完整的循环。 料头夹持 / 机械手 开 / 关 料头夹持 / 机械手 相关位置 料头夹持 / 机械手 单步模式 机械手 归位

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另外，在翻译过程中最好以“段落”或者“长句”作为翻译的基本单位，这样才不会造成“只见树木，不见森林”的误导。 注： 1、Google翻译：https://www.wendangku.net/doc/eb12285466.html,/language_tools google，众所周知，谷歌里面的英文文献和资料还算是比较详实的。我利用它是这样的。一方面可以用它查询英文论文，当然这方面的帖子很多，大家可以搜索，在此不赘述。回到我自己说的翻译上来。下面给大家举个例子来说明如何用吧 比如说“电磁感应透明效应”这个词汇你不知道他怎么翻译， 首先你可以在CNKI里查中文的，根据它们的关键词中英文对照来做，一般比较准确。 在此主要是说在google里怎么知道这个翻译意思。大家应该都有词典吧，按中国人的办法，把一个一个词分着查出来，敲到google里，你的这种翻译一般不太准，当然你需要验证是否准确了，这下看着吧，把你的那支离破碎的翻译在google里搜索，你能看到许多相关的文献或资料，大家都不是笨蛋，看看，也就能找到最精确的翻译了，纯西式的！我就是这么用的。 2、CNKI翻译：https://www.wendangku.net/doc/eb12285466.html, CNKI翻译助手，这个网站不需要介绍太多，可能有些人也知道的。主要说说它的有点，你进去看看就能发现：搜索的肯定是专业词汇，而且它翻译结果下面有文章与之对应（因为它是CNKI检索提供的，它的翻译是从文献里抽出来的），很实用的一个网站。估计别的写文章的人不是傻子吧，它们的东西我们可以直接

英文汉字巧切换

第11课英文汉字巧切换教学目标： 1. 知识目标： 知道英文和汉字需要在不同的状态下输入，掌握切换输入状态的方法，了解如何在“智能ABC输入法”中输入特殊字符。 2. 能力目标： 体验两种输入状态的作用以及切换的技巧，加深对输入法的理解。 3. 情感目标： 培养学生学习文字输入的热情和探究意识，提高学生的文字信息处理能力。 重点和难点 教学重点：切换英文和汉字的输入状态。 教学难点：输入特殊的字符。 教学方法： 任务驱动法，自主探究法，小组合作。 教学准备：多媒体课件。 教学过程： 一、动漫故事导入： 同学们喜欢听歌吗？听听这首歌是什么。（生答）今天《熊出没》中的人物来陪我们了，看看他们在做什么吧。课件播放光头强与熊大熊二对话，引入闯关任务：第一关：输入水果单词比赛。 苹果apple 香蕉banana 桔子orange 桃子peach 梨子pear 葡萄grape 熊二看到这么多好吃的水果，非常高兴，可是自己不会打字，就想到找小朋友们帮忙。小朋友们仔细观察上面的单词，发现有汉字，也有英文，这就需要切换输入法，这就是我们今天要学习的内容。引入课题：英文汉字巧切换。 二、合作闯关，学习新知： 1、先闯第一关，输入单词。

启动记事本或写字板，准备输入。提醒学生注意打字姿势。 （输入完成的小组组员可以为自己小组赢得一颗星，得星办法：用笔在老师事先准备好的表格中画一颗星。） 请一同学演示并讲解他的操作方法，并给自己小组加星星。 注意：学生有可能使用搜狗输入法，搜狗输入法可直接输入汉语和英文，也可使用shift切换。智能ABC和搜狗拼音输入法的不同。 输入法种类：智能ABC，全拼输入法，搜狗拼音输入法，五笔输入法，QQ拼音输入法等多种，各有各的优点。 使用时，根据自己的情况选择自己喜欢的输入法。 老师提示切换中英文输入状态的方法：Ctrl键+空格。 利用Ctrl键+空格，试一试： 男孩boy 女孩girl 妈妈mother 爸爸father 叔叔uncle 阿姨aunt 学校school★ 学生自主尝试，师巡回指导，纠正个别学生的坐姿及打字指法。 学生在输入过程中发现在“学校school”后面加了★，★该怎么输入呢？ 2、第二关：特殊符号的输入 出示光头强任务：输入下列特殊符号： ●◎■☆§※★ 学生合作学习，探究特殊符号的输入方法。 师巡回指导。 请一学生演示操作,并讲述步骤。 这一关过后，小组仍可得到星星。 查看小组得星情况，表扬得星多的小组，鼓励其他小组。 3、第三关：输入水果食物儿歌。 听儿歌，并把儿歌歌词输入到记事本中。 播放儿歌，出示儿歌内容，学生开始输入。师巡回指导。 输入完成的小组添星星。 学生输入完毕，闯关成功。

UP2000(2)中文操作

4.點取CANCEL（取消）按鈕,表示不要從磁片存入機器內硬碟機。 File transfer complete. 1 files transferred Press NEXT to Continue. File transfer complete. (程式檔案存入到磁片已完成) 1 files transferred(一個程式檔案存入到磁片) Press NEXT to Continue. (按NEXT繼續) ※因程式檔案多寡,所顯示程式檔案訊息不同 8.Save Timing File將目前程式檔案有關時間參數存入到磁片 ※此功能是將目前生產程式檔案內,有關時間參數存入到磁碟片中,如印刷完一片所需時間、等待時間等等…..

Utilities 1.Load Board載入PC板於中心點位置及視覺系統位置,頂到鋼板位置

※ Load Board 進板指令集是將PC 板送進機器內,Z AXIS 將會升高到不同高度,當你在下拉 式選項Utilities 中選擇時,螢幕上會出現手動進板(Manual Load Board)的螢幕如上圖。 1. 鋼板高度(Stencil Height)：將PC 板上升至鋼板的高度,這是可以查看PC 板 是否完全密和頂到鋼板及PC 板與鋼板有無對位。 2. 鏡頭高度(Vision Height)：將PC 板上升至視覺影像高度,這是可以查看PC 板Mark 點是否錯誤。 3. 定位工具高度(Tooling Height)：將PC 板上升至定位工具高度,這是可以查 看PC 板吸真空是否定位良好及調整支撐 PIN(Support PIN)位置。 4. Begin ：開始送板到印刷區位置並依照上述設定上升高度 5. Detent ：載入PC 板向前與向後於中心點位置 6. Exit ：跳出手動進板的畫面,回到主畫面 2. Stencil Height 測PCB 板到鋼板厚度 This utility will the set STENCIL height. (要開始使用偵測鋼板高度) Press NEXT to Continue, or EXIT to Quit. (按NEXT 繼續, 按EXIT 離開) 你按NEXT 之後，出現下列訊息及視窗： CAUTION, The machine is now going to (警告,機器現在要移動,內部不能有 move. STAY CLEAR.任何東西,需清除) This utility will the set STENCIL height. Press NEXT to Continue, or EXIT to Quit. CAUTION, The machine is now going to move. STAY CLEAR. Press NEXT to Continue, or EXIT to Quit.

产品中英文描述

1. 型号: BM2033 2. 名称: 双USB车充 3. DC输入: 12V~24V/10A(MAX) 4. DC输出USB-L: 5V/600mA 5. DC 输出USB-H:5V/1A 6. 尺寸: 43*33*68mm (直径:20.5mm) 7. 材料: ABS 8. 功能1: 车充 功能2: 给手机,iPhone, iPad充电 9.包装: 白盒 1. ITEM: BM2033 2. NAME: CAR CHARGER 3. DC input: 12V~24V/10A (MAX) 4. DC output (USB-L): 5V/600 mA 5. DC output (USB-H): 5V/1A 6. Size: 43*33*68mm (Φ 20.5mm) 7. Material: ABS 8. Function 1: car charger Function 2: Charging mobile phone, iPhone, iPad 9. Package: white box BM2087WT 1.名称: 太阳能充电器&暖手器 2.太阳能板:5.0V/70mA 0.35W 3.锂电池: 1200mAh(±5%) 4.DC输入: 5V 500mA 5.DC 输出:5V 300 ~ 500mA 6.尺寸: 95*44*11mm

7.材料: 铝壳 8.功能1: 给手机充电 功能2: 照明 功能3: 暖手 9.配件: Nokia 6101, Micro USB, Mini USB, IPHONE, Extended or USB cable 10.包装: 白盒 https://www.wendangku.net/doc/eb12285466.html,: Solar Charger & Warmer 2.Solar: 5.0V/70mA 0.35W 3.Li battery: 1200mAh(±5%) 4.DC input: 5V 500mA 5.DC output: 5V 300 ~ 500mA 6.Size: 95*44*11mm 7.Material: Aluminum 8.function1: charging mobile phone function2: torch function3: warm hand 9.Accessories: Nokia 6101, Micro USB, Mini USB, IPHONE, Extended or USB cable 10.Packing: White box BM2087PS 1.名称: 太阳能充电器 2.太阳能板:5.0V/70mA 0.35W 3.锂电池: 800mAh(±5%) 4.DC输入: 5V 500mA 5.DC 输出:5V 300 ~ 500mA 6.尺寸: 95*44*11mm 7.材料: 铝壳 8.功能1: 给手机充电 功能2: 电池电量检测 9.配件: Nokia 6101 Micro USB, Mini USB iPhone, USB cable, Extended cable 10. 包装: 白盒 https://www.wendangku.net/doc/eb12285466.html,: Solar Charger

彩妆产品中英文对照

【女生必备彩妆用品的常用英文】MISSBIG专业彩 妆 彩妆: cosmetics 遮瑕膏: concealer 修容餅:Shading powder 粉底: foundation (compact,stick) 粉饼: pressed powder 散粉:loose powder 闪粉:shimmering powder/glitter 眉粉: brow powder 眉笔:brow pencil 眼线液(眼线笔):liquid eye liner, eye liner 眼影: eye shadow 睫毛膏: mascara 唇线笔: lip liner 唇膏: lip color/lipstick(笔状 lip pencil,膏状 lip lipstick,盒装 lip color/lip gloss) 唇彩: lip gloss/lip color

腮红: blush 卸妆水: makeup remover 卸妆乳: makeup removing lotion 指甲: manicure/pedicure 指甲油: nail polish/color/enamel 去甲油:nail polish remover 护甲液:Nail saver 发: hair products/accessories 洗发水: shampoo 护发素: hair conditioner 锔油膏: conditioning hairdressing/hairdressing gel /treatment 摩丝: mousse 发胶: styling gel 染发: hair color 冷烫水: perm/perming formula 卷发器: rollers/perm rollers 工具: cosmetic applicators/accessories

英文汉字巧切换

英文汉字巧切换 Company number【1089WT-1898YT-1W8CB-9UUT-92108】

第11课英文汉字巧切换 教学目标： 1.知识目标： 知道英文和汉字需要在不同的状态下输入，掌握切换输入状态的方法，了解如何在“智能ABC输入法”中输入特殊字符。 2.能力目标： 体验两种输入状态的作用以及切换的技巧，加深对输入法的理解。 3.情感目标： 培养学生学习文字输入的热情和探究意识，提高学生的文字信息处理能力。 重点和难点 教学重点：切换英文和汉字的输入状态。 教学难点：输入特殊的字符。 教学方法： 任务驱动法，自主探究法，小组合作。 教学准备：多媒体课件。 教学过程： 一、动漫故事导入： 同学们喜欢听歌吗？听听这首歌是什么。（生答）今天《熊出没》中的人物来陪我们了，看看他们在做什么吧。课件播放光头强与熊大熊二对话，引入闯关任务：第一关：输入水果单词比赛。 苹果apple香蕉banana桔子orange 桃子peach梨子pear葡萄grape 熊二看到这么多好吃的水果，非常高兴，可是自己不会打字，就想到找小朋友们帮忙。小朋友们仔细观察上面的单词，发现有汉字，也有英文，这就需要切换输入法，这就是我们今天要学习的内容。引入课题：英文汉字巧切换。 二、合作闯关，学习新知： 1、先闯第一关，输入单词。 启动记事本或写字板，准备输入。提醒学生注意打字姿势。

（输入完成的小组组员可以为自己小组赢得一颗星，得星办法：用笔在老师事先准备好的表格中画一颗星。） 请一同学演示并讲解他的操作方法，并给自己小组加星星。 注意：学生有可能使用搜狗输入法，搜狗输入法可直接输入汉语和英文，也可使用shift切换。智能ABC和搜狗拼音输入法的不同。 输入法种类：智能ABC，全拼输入法，搜狗拼音输入法，五笔输入法，QQ拼音输入法等多种，各有各的优点。 使用时，根据自己的情况选择自己喜欢的输入法。 老师提示切换中英文输入状态的方法：Ctrl键+空格。 利用Ctrl键+空格，试一试： 男孩boy女孩girl妈妈mother爸爸father 叔叔uncle阿姨aunt学校school★ 学生自主尝试，师巡回指导，纠正个别学生的坐姿及打字指法。 学生在输入过程中发现在“学校school”后面加了★，★该怎么输入呢？ 2、第二关：特殊符号的输入 出示光头强任务：输入下列特殊符号： ●◎■☆§※★ 学生合作学习，探究特殊符号的输入方法。 师巡回指导。 请一学生演示操作,并讲述步骤。 这一关过后，小组仍可得到星星。 查看小组得星情况，表扬得星多的小组，鼓励其他小组。 3、第三关：输入水果食物儿歌。 听儿歌，并把儿歌歌词输入到记事本中。 播放儿歌，出示儿歌内容，学生开始输入。师巡回指导。 输入完成的小组添星星。 学生输入完毕，闯关成功。 查看小组得星情况，表扬得星多的小组，鼓励其他小组。 熊大熊二非常高兴，光头强只能履行自己的诺言。

要上传产品名称中英文对照1

要上传产品名称中英文对照1

1）烘干机设备系列：Dryer Equipment Series 转筒烘干机Rotary dryer 煤泥烘干机Coal Slime Rotary Dryer 沙子烘干机Sand Rotary Dryer 生物肥烘干机Bio-Fertilizer Dryer 高湿物料烘干机High Humidity Material Dryer 2)回转窑系列：Rotary Kiln Series 回转窑Rotary Kiln 冶金回转窑Metallurgy Rotary Kiln 石灰回转窑Lime Rotary Kiln 水泥回转窑 Cement Rotary Kiln 活性石灰生产线Active Lime Production Line 输送设备系列Conveyor Series 输送机系列Conveyor 皮带输送机Belt Conveyor 斗式提升机 Bucket Elevator 振动给料机Vibrating Feeder 螺旋输送机Screw Conveyor 链式输送机Chain Conveyor 卧式给料机Horizontal Feeder 3)除尘设备系列：Dust Catcher Equipment 脱硫除尘器Desulfurization Dust Catcher 袋式脉冲除尘器Beg Pulse Dust Catcher 单筒旋风除尘器Monocular Cyclone Dust Catcher 静电除尘器Static Electricity Dust Catcher

湿式除尘器wet-type dust catcher 双筒旋风除尘器Binocular,Cyclone Dust Catcher 4)煤气发生炉系列：Coal Gasifier Series 两段式煤气发生炉Double-Stage Coal Gasifier QM-1型煤气发生炉QM-1 Coal Gasifier QM-2型煤气发生炉QM-2 Coal Gasifier 喷煤机Coal Spraying Machine 单段煤气发生炉 Single-Stage Coal Gasifier 5）冷却机设备系列Cooling Machine Series 冷却机Cooling Machine 6）破碎设备系列Crushing Equipment Series 对辊破碎机2-Roller Crusher 颚式破碎机Jaw crusher 锤式破碎机Hammer crusher 立式复合破碎机Vertical Combination Crusher 齿辊破碎机Gear-Roller Crusher 反击破碎机Impact crusher 7）选矿设备系列Ore Dressing Equipment Series 球磨机Energy Saving Ball Mill 浮选机Floatation separator洗砂机Sand Washing

产品介绍(中英文)

上海驰赢机械制造有限公司 Shanghai Chiying Machine Manufacturing Co., Ltd. 一．CYF型彩钢夹芯复合流水线 1.CYF型生产线采用先进的生产工艺以气，电，机械为一体，是加工和平隔热彩钢夹芯板的专用机械设备。 2.CYF型生产线工作速度采用电脑控制无极调速，使该生产线运行速度稳定，操作简单。 3.CYF型生产线根据用户的需求，长度由电脑定位控制。该系统定位精确，且在触摸屏上定时显示，并自动计数。 4.CYF型多功能复合机生产流水线，配套制度的成型，可以生产多种板型。 5.瓦楞复合机的板型可以根据用户的需要进行设计和修改，以满足不同用户的需要。 Compound production line for CYF color-steel sandwich plate 1.CYF production line adopts advanced technology integrating pneumatic, electric and mechanical technologis. It is the special machine for the production of the heat insulated coler-steel sandwich plates. 2.The operation speed of CYF production line is stepless computer-controlled to realize the stable operation speed and simple operation of the production line. 3.The length of the CYF production line can be controlled by the computer system based on the user’s requirements. The computer system has precise orientation and has timed display on the touch screen. And it has automatic counting and correcting. 4.CYF multiple-function compound production line is equipped with the molding machine and can produce 10 types of plates. 5.The shapes of the corrugated compound plates can be designed and modified according to user’s requirements so as to satisfy needs of different users. 设备概况： CYF型彩钢夹芯板复合流水线设备，能一次性复合瓦楞型复合板，全套流水线由装料开卷系统、成型系统、切割装置、复合系统（压筋、涂胶、加温、复合、卷边、开槽、整边、气动、自动切断）组成，整个过程由电脑控制，是生产工业厂房，仓库等房面板和墙板不可缺少的设备。 Equipment summary: CYF color-steel sandwich plate compound production line can compound the corrugated compound plates for once. The whole set production line is composed of the feed unrolling system, molding system, cutting device, compounding system (rib pressing, glue coating, heating, compounding, flanging, notching, trimming, pneumatic and automatic cutting). The whole process is computer-controlled. It is the necessary equipment for producing the faceplates and wallboards for industrial workshops and warehouses.

中英文产品质量保证书

中英文产品质量保证书 日期：2014-04-01 the product quality guarantee english： the products we provided to the shandong rizhao huagui technology limited company are in accord with the country's related standards and the industry standards. we guarantee five years' free repair. we promise the color of the lacquer not fade away in five years, the lacquer not peel off in two years. company name:(seal of the full name of material company) tel:1 date:2014-04-01 第二篇：产品质量保证书 产品质量保证书 河南省双宝科技实业有限公司自成立以来，一直将产品质量定位为公司参与市场竞争的核心，正是这个成功的定位和双宝公司全体员工强烈的产品质量意识，使双宝公司以成为中国电测、监控行业的知名企业。 公司根据产品质量要求，建立了严密的质量检验体系。公司对与产品质量有关的所有环节进行严格控制与管理，建立了科学的检验规程，并对检验指标进行了量化，责任到人，确保公司持续稳定生产合格的产品。 公司从原材料严格把关，杜绝三无产品，选用国内外名牌厂家的产品，建立严格的产品工艺指标，并与供方建立良好的供求关系。 双宝公司建立了定期的员工质量培训制度，学习质量管理的新知识、新信息，树立每一个员工的质量意识，规范自己行为，小到一个焊点、一根电线，大到一台整机都做到一丝不苟、精益求精。质检部门建立了规范的检验规程，具备先进完善的检测设备和手段，并严格按照规程检验，作好产品7天老化实验，不让一台不合格产品出厂。 公司产品每年都经过河南省技术检测所检测，各项性能指标全部一次检测合格。我们将不懈的努力为用户提供满意的产品和服务。 产品质量保证书