EUGMP正文中英文旧版本

FOREWORD

The Pharmaceutical Industry of the European Community maintains high standards of Quality Assurance in the development, manufacture and control of medicinal products. A system of Marketing Authorisation ensures that all medicinal products are assessed by a Competent Authority to ensure compliance with contemporary requirements to safety, quality and efficacy. A system of Manufacturing Authorisation ensures that all products authorised on the European market are manufactured only by authorised manufacturers, whose activities are regularly inspected by the Competent Authorities. Manufacturing Authorisations are required by all pharmaceutical manufacturers in the European Community whether the products are sold within or outside of the Community.

欧盟的制药工业在医药产品的研发、生产和质量控制的全过程中均保持着高标准的质量保证活动。市场授权系统保证所有的医药产品都要接受有权机构的评估，保证符合当前的安全、质量和有效性的要求。市场授权系统保证所有允许上市的医药产品均由授权的生产商生产，有权机构定期检查生产商的生产活动。所有在欧盟内生产商必需获得市场授权，不论其产品是否在欧盟内销售。

Two directives laying down principles and guidelines of good manufacturing practice(GMP) for medicinal products where adopted by the Commission in 1991, the first for medicinal products for human use (Directive 91/356/EEC), the second one for veterinary use(Directive 91/412/EEC). Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice which will be used in assessing applications for Manufacturing authorisations and as a basis for inspection of manufacturers of medicinal products.

1991年欧盟理事会通过了两个法令，规定了医药产品的生产质量管理规范（GMP）的原则和指导方针。第一个法令是关于人体用药（Directive 91/356/EEC），第二个法令是关于兽用药（Directive 91/412/EEC）。公布的生产质量管理规范指南中，有详细的原则和指导方针，将用于生产授权申请的评估和检查医药生产商的最基本要求。

The principles of GMP and the detailed guidelines are applicable to all operations which require the authorisation referred to in Article 16 of and Article 24 of Directive 81/851/EEC as modified. They are also relevant for all other large scale pharmaceutical manufacturing processes, such as that undertaken in hospitals, and for the preparation of products for use in clinical trails.

参照修订版Directive 81/851/EEC中文件第16和第24，详细的GMP原则和指导方针适用于需获得市场授权的生产商的全部活动，也有其他广泛的与制药生产的相关过程如在医院的活动，以及产品的临床试验。

All member States and the Industry itself are agreed that the GMP requirements applicable to the manufacture of veterinary medicinal products are the same those applicable to the manufacture of medicinal products for human use. Certain detailed adjustments to the GMP guidelines are set out

in two annexes specific to veterinary medicinal products and to immunological veterinary medicinal products.

所有的成员国以及制药工业业界均同意适用于兽用药生产的GMP要求与人体用药的GMP 要求一致。GMP指导方针的相应细节的调整在法令的两个附件兽用药和兽用免疫药中有具体规定。

The Guide is presented in chapters, each headed by a principle. Chapter 1 on Quality Management outlines the fundamental concept of Quality Assurance as applied to the manufacture of medicinal products. Thereafter each chapter has a principle outlining the Quality Assurance objectives of that chapter and a text which provides sufficient detail for manufacturers to be made aware of the essential matters to be considered when implementing the principle.

本指南按章展开，每一章介绍一个原则并以其为标题。第1章关于质量管理，列出了医药产品生产质量保证的基本理念。此后每一章均关于一个原则，列出相应的质量保证目标并有文字阐述具体的要求，以使生产商在实施GMP原则时清楚知道必须遵循的基本要素。

In addition to the general matters of Good Manufacturing Practice outlined the 9 chapters of this guide, a series of annexes providing detail about specific areas of activity is included. For some manufacturing processes, different annexes will apply simultaneously (e.g. annex on sterile preparations and on radiopharmaceuticals and/or on biological medicinal products).

作为对9章介绍的GMP一般要素的补充，本指南包括了一系列的附件，提供的具体活动领域的要求。对一些生产工艺，不同的附件可同时适用（如灭菌制剂和放射性药品以及生物制品）。

A glossary of some terms used in the Guide has been incorporated after the annexes.

附件后有词汇表，给出了本指南所使用的一些词汇的解释。

The first edition of the Guide was published in 1989, including an annex on the manufacture of sterile medicinal products.

本指南的第一版公布于1989年，包含了一个关于无菌医药产品的附件。

The second edition was published in January 1992; including the Commission Directive 91/356 of 13 June 1991 and 91/412 of 23 July 1991 laying down the principles and guidelines on good manufacturing practice for medicinal products for human use as well as for veterinary medicinal products. The second edition also included 12 additional annexes.

第二版公布于1992年1月，包括了理事会91年6月13日的法令Directive 91/356和91年7月23日的法令Directive91/412，规定了人用药和兽用药的GMP的原则和指导方针。

The basic requirements in the main guide have not been modified. 14 annexes on the manufacture

of medicinal products have been included in this third edition.

第3版指南的基本要求未做修改，还包括了14个关于医药生产的附件。

The Guide is not intended to cover security aspects for the personnel engaged in manufacture. This may be particularly important in the manufacture of certain medicinal products such as highly active, biological and radioactive medicinal products, but they are governed by other provisions of Community or national law.

本指南不预包含有关从事生产的人员安全内容。这可能对于某些医药产品的生产，如高活性、生物制品和放射性医药产品，是非常重要的，但这些方面由欧盟其他法令或国家法律管理。

Throughout the Guide it is assumed that the requirements of the Marketing Authorisation relating to the safety, quality and efficacy of the products, are systematically incorporated into all the manufacturing, control and release for sale arrangements of the holder of the Manufacturing Authorisation.

本指南认为，获得市场授权的产品其安全、质量和有效性要求，是在授权生产商的系统的生产、质量控制和放行活动中实现的。

The manufacture of medicinal products has for many years taken place in accordance with guidelines for Good Manufacturing Practice and the manufacture of medicinal products is not governed by CEN/ISO standards. Harmonised standards as adopted by the European standardisation organizations CEN/ISO may be used at industry’s discretion as a tool for implementing a quality system in the pharmaceutical sector. The CEN/ISO standards have been considered but the terminology of these standards has not been implemented in this third edition of the Guide.

根据GMP指导方针而不是欧盟标准化组织的标准生产医药产品已历时多年。欧盟标准化组织制定的统一的标准可以作为医药工业实施的质量体系的判断工具。CEN/ISO标准已被考虑但尚未纳入本第三版指南以实施。

It will be regularly revised.

本指南会被定期修订。

TABLE OF CONTENTS

TABLE OF CONTENTS (i)

CHAPTER 1 QUALITY MANAGEMENT (1)

Principle (1)

Quality Assurance (1)

Good manufacturing Practice for Medicinal Products (GMP) (3)

Quality Control (5)

CHAPTER 2 PERSONNEL (7)

Principle (7)

General (7)

Key Personnel (8)

Training (11)

Personnel Hygiene (12)

CHAPTER 3 PREMISES AND EQUIPMENT (15)

Principle (15)

Premises (15)

General (15)

Production Area (16)

Storage Areas (18)

Quality Control Area (19)

Ancillary Areas (20)

Equipment (20)

CHAPTER 4 DOCUMENTATION (23)

Principle (23)

General (23)

Documents required (25)

Specifications (25)

Specifications for starting and packaging material (25)

Specifications for intermediate and bulk products (26)

Specifications for finished products (27)

Manufacturing Formula and Processing Instructions (27)

Packaging Instructions (29)

Batch Processing Records (30)

Batch Packaging Records (31)

Procedures and records (33)

Receipt (33)

Sampling (34)

Testing (35)

Other (35)

CHAPTER 5 PRODUCTION (37)

Principle (37)

General (37)

Prevention of cross-contamination in production (39)

Validation (41)

Starting materials (41)

Processing operations: intermediate and bulk products (43)

Packaging materials (44)

Packaging operations (45)

Finished products (47)

Rejected materials, recovered and returned materials (48)

CHAPTER 6 QUALITY CONTROL (50)

Principle (50)

General (50)

Good Quality Control Laboratory Practice (51)

Documentation (51)

Sampling (53)

Testing (54)

CHAPTER 7 CONTRACT MANUFACTURE AND ANALYSIS (57)

Principle (57)

General (57)

The Contract Giver (58)

The Contract Acceptor (58)

The Contract (59)

CHAPTER 8 COMPLAINTS AND PRODUCT RECALL (61)

Principle (61)

Complaints (61)

Recalls (62)

CHAPTER 9 SELF INSPECTION (64)

Principle (64)

CHAPTER 1 QUALITY MANAGEMENT 质量管理Principle

原理

The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place any patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporation Gooding Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality Aussrance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).

授权的生产者必须保证其生产出的产品不仅满足预定使用目的，而且符合其授权的市场范围，同时不得销售任何因安全性、质量或有效性不足而具有风险的专利产品。实现这一质量目标，既是公司的高级管理层的职责，也需要公司各级各部门员工以及公司的供应商和分销商的承诺和参与。为可靠地实现这一质量目标，必须建立一个经系统设计并正确实施的质量保证体系，也要包含生产质量管理规范和质量控制的内容。该体系必须形成完整的文件并监测其有效性。质量保证体系的每一环节应配制充足的各类资源：胜任的人员，合适和充足的生产环境、设备和设施。授权的生产者和质保人员还负有额外法律责任。

1.1The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control

are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.

质量保证、生产质量管理规范和质量控制的基本理念是相互联系的。为强调三者间的相互联系以及他们在药品生产和质量控制中所具有的根本重要性，下面对这三个概念进行一一说明。

Quality Assurance

质量保证

1.2Quality Assurance is a wide ranging concept which covers all matters which individually or

collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.

质量保证是一组内容广泛的理念，包括了一切单独影响或整体影响产品质量的因素，是为了实现药品质量能满足预定使用目的这一目标而采取的所有措施的总和。因此，质量保证不仅包括了生产质量管理规范，也包括本指导方针未提及的其他因素。

The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:

适于药品制造的质量保证体系必须保证：

i.medicinal products are designed and developed in a way that takes account of the

requirements of Good Manufacturing Practice and Good Laboratory Practice;

药品的设计、开发遵循生产质量管理规范和非临床研究质量管理规范的要求；

ii.Production and control operations are clearly specified and Good Manufacturing Practice adopted;

一切生产和质量控制活动是明确而具体规定的，且采用了生产质量管理规范；

iii.managerial responsibilities are clearly specified;

管理者职责是明确而具体的；

iv.arrangement are made for the manufacturer, supply and use of the correct starting and packaging materials;

采取措施，提供正确的原材料和包装材料用于生产；

v.all necessary controls on intermediate products and any other in-process controls and validations are carried out;

实施所有必须的对中间品的质量控制和任何其他中间控制，并做验证；

vi.the finished products is correctly processed and checked, according to the defined procedures;

产成品的生产和检验应根据规定的程序；

vii.medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the

requirements of the marketing Authorisation and any other regulations relevant to the

production, control and release of medicinal products;

任何药品的销售或提供，必须经质保人员的审核以确认该批号产品的生产和质量

控制符合授权的市场范围，满足与药品生产、质量控制和产品放行相关的法规要

求。

viii.satisfactory arrangements exits to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained

throughout their shelf life;

在仓储、运输和后续销售过程中，应尽可能多的采取较为满意的措施，保证药品

在有效期内的质量；

ix.there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system.

有自查程序和/或质量审计程序，来定期评价质量保证体系的有效性和适用性。Good manufacturing Practice for Medicinal Products (GMP)

药品生产质量管理规范(GMP)

1.3Good manufacturing Practice is that part of Quality Assurance which ensures that products are

consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:

生产质量管理规范是质量保证的一部分，主要是保证产品的生产和质量控制一贯地符合质量标准，以适于其预定使用目的并满足授权市场或产品质量标准的要求。生产质量管理规范包括了生产和质量控制的内容，其基本要求如下：

i.all manufacturing process are clearly defined, systematically reviewed in the light of

experience and shown to be capable of consistently manufacturing medicinal

products of the required quality and complying with their specifications;

一切生产工艺应予以明确定义，并在实际运用中经系统性的评价，以证明能够

满足持续生产具有高质量、符合质量规范的药品；

ii.critical steps of manufacturing processes and significant changes to the process are validated;

生产工艺的关键步骤和重要的工艺变更必须经过验证；

iii.all necessary facilities for GMP are provided including:

除必要的生产设备外，还应包括以下：

a.appropriately qualified and trained personnels;

适当地具有资格的经培训的人员；

b.adequate premises and space;

适宜的生产环境和空间

c.suitable equipment and services;

合适的机器和服务；

d.correct material, containers and labels;

正确的物料，容器和标识；

e.approved procedures and instructions;

批准的程序和工作指导书；

f.suitable storage and transport;

适宜的存储和传送；

iv.instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;

应有书面的工作指导书和程序，且语言表达条理、明确，如果可能每台设备应

有专门的文件；

v.operators are trained to carry out procedure correctly;

操作人员是经过培训能够正确执行程序；

vi.records are made, manually and/or by recording insruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated.

在生产中，由人工和/或由记录仪器做好记录，以证明按照程序和工作指导书规

定的步骤都一一被执行，而且产品符合质量要求。任何重要的偏差要完整记录，

并做调查。

vii.the distribution (wholesaling) of the products minimises any risk to their quality;

产品的分销（整个销售）过程应把任何影响质量的风险尽可能降到最低；

viii. a system is available to recall any batch of product, from sale or supply;

应有一个产品召回体系，从销售或供应环节；

https://www.sodocs.net/doc/a52451883.html,plaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and

to prevent reoccurrence.

调查对市场上销售的产品的投诉，找出产生质量瑕眦的原因并采取适当针对措

施以避免不合格产品再度出现。

Quality Control

1.4Quality control is that part of Good Manufacturing Practice which is concerned with sampling,

specifications and testing, and which the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that material are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.

质量控制是生产质量管理规范的一部分，主要内容是抽样、质量标准和检测，通过一定的组织、文件和放行程序来保证：原料在经放行允许使用前和产品在经放行允许销售和供应前，所有必需和相关的测试已完成，且其质量是满意的。

The basic requirements of Quality Control are that:

i.adequate facilities, trained personnel and approved procedures are available for

sampling, inspecting and testing starting materials, packaging materials, intermediate,

bulk, and finished products, and where appropriate for monitoring environmental

conditions for GMP purposes;

对原材料、包装材料、中间品、半成品和成品的抽样和检测，应有充足的设备，

培训的人员和批准的程序，以及适当的根据GMP要求对环境条件的监测；

ii.samples of starting materials, packaging materials, intermediate product, bulk products and finished products are taken by personnel and by methods approved by

Quality Control;

相应的人员对原材料、包装材料、中间品、半成品和成品的抽样应根据质量控

制批准的程序；

iii.test method are validated;

测试方法是经验证的；

iv.records are made, manually and/or by recording instruments, which demonstrated that all the required sampling, inspecting and testing procedures were actually carried out.

Any deviations are fully recorded and investigated;

人工和/或仪器做好记录，以证明所需的抽样、检验和测试程序已确实完成。任

何偏差应完整地记录并做调查；

v.the finished products contain active ingredients complying with the qualitative and quantitative composition of the Marketing Authorisation, are of the purity required, and are enclosed within their proper containers and correctly labeled;

成品中含有的活性成份的质和量应符合授权市场的成份要求，达到相应的纯度，并装在合适的容器里，贴上正确的标识；

vi.records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification.

Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviation from specified procedures;

原材料、包装材料、中间品、半成品和成品的检验和测试均应做记录，并根据

质量标准正式评价。产品评价包括对生产相关文件的回顾评估，以及根据具体

程序对偏差的评估。

vii.no batch of product is released for sale or supply prior to certification by a Qualified Person that it is in accordance with the requirements of the Marketing Authorisation;

只有在质保人员确认产品质量符合授权市场的要求后，一批产品才能够放行用

于销售或供应；

viii.sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.

有足够的原材料和产品留样以备日后产品检验之需，留样的产品应是同样的最

终包装规格除非原包装规格太大。

CHAPTER 2 PERSONNEL 人员

Principle

原理

The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affects them and receive initial and continuing training, including hygiene instructions, relevant to their needs.

一个满意的质量保证体系的建立和保持，以及药品的正确生产均依赖于人的作用。因此，必须具有充足的有资格的人员来完成由生产者的职责所规定的各项任务。每个人应明确知晓个人职责，并有相应书面记录。所有人员应掌握生产质量管理规范的基本原理，接受岗前培训，并根据他们的需要，给予继续的培训如卫生学知识。

General

概述

2.1The manufacturer should have an adequate number of personnel with the necessary

qualifications and practical experience. The responsibilities placed on one individual should not be so extensive as to prevent any risk to quality.

生产者应有充足数量的具有资格和和实际经验的人员。个人所承担的职责不应是无限的以防止带来任何质量风险。

2.2The manufacturer must have an organisation chart. People in responsible positions should

have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.

生产者必须有组织机构图。承担职责的人员应有具体的职位和书面的工作说明，通过充分的授权以实现其职责。可能因具有较满意资格，某些人员会被授以指定职责的管理者代表。在生产质量管理规范实施过程中，不能有职责空白或未职责不清、职责重复。

Key Personnel

关键人员

2.3Key personnel include the head of Production, the head of Quality Control, and if at least one

of these persons are not responsible for the duties described in Article 22 of Directive 75/319/EEC, the Qualified Person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large oragnisations, it may be necessary to delegate some of the functions listed in 2.5, 2.6 and 2.7.

关键人员包括生产负责人和质量控制负责人，若至少其中一人不承担Directive 75/319/EEC中第22篇文件规定的职责，需有指定的质保人员承担该职责。一般而言，关键人员应是全职的工作人员。生产和质量负责人必须相互独立。在大型的组织中，可能需要有专门指定人员承担2.5, 2.6 和2.7项职责。

2.4The duties of the Qualified Person(s) are fully described in Article 22 of 75/319/EEC, and can

be summarised as follows:

质保人员的职责在Directive 75/319/EEC中文件第22中有明确规定，现概括如下：

a)for medicinal products manufactured within the European Community, a Qualified Person

must ensure that each batch has been produced and tested/checked in accordance with the directives and the marketing authorisation(1);

在欧盟生产的医药产品，必须有质保人员保证每一批产品的生产和测试/检验均符合法案和市场授权的要求；

b)for medicinal products manufactured outside the European Community, a Qualified

Person must ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1(b) of Article 22;

在欧盟之外生产的医药产品，质保人员必须保证每一批进口的产品已在相应的进口国通过了文件第22第一段b中具体规定的所有测试。

c) a Qualified Person must certify in a register or equivalent document, as operations are

carried out and before any release, that each production batch satisfies the provisions of Article 22.

1According to Directive 75/319/EEC and the Ruling (Case 247/81) of the Court of Justice of the European Communities, medicinal products which have been properly controlled in the EU by a Qualified Person do not have to be recontrolled or rechecked in any other Member State of the Community.

根据Directive 75/319/EEC和欧盟最高法院的决定（文件247/81），由成员国的质保人员正确地临控下生产的医药产品，在欧盟任一成员国，不需要接受再控制或检测。

质保人员必须在记录或相应文件中证明，在每一批产品放行前，所有文件第22中规

定项确实已经完成。

2.5The head of the production Department generally has the following responsibilities:

生产部负责人主要具有以下责任：

i.to ensure that products are produced and stored according to the appropriate

documentation in order to obtain the required quality;

保证产品的生产和储存是按照适当的文件要求以获得要求的质量；

ii.to approve the instructions relating to production operations and to ensure their strict implementation;

批准与生产操作相关的工作指导书，并保证其严格的执行；

iii.to ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department;

保证在生产记录送至质控部前，已由授权的人审核和签名；

iv.to check the maintenance of his department, premises and equipment;

检查其部门的环境和设备的维护状况；

v.to ensure that the appropriate validations are done;

保证有关的验证已完成；

vi.to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

保证部门的人员接受必须的岗前和继续培训，且根据实际需要作相应调整。

2.6the heads of the Quality Control Department generally has the following responsibilities:

质控部负责人主要具有以下责任：

i.to approve or reject, as he sees fit, starting materials, packaging materials, and

intermediate, bulk and finished products;

如他认为合适，批准或拒绝原料、包装材料、中间品、半成品和成品的放行；

ii.to evaluate batch records;

评估批生产记录；

iii.to ensure that all necessary testing is carried out;

保证所有必需的检测已完成；

iv.to approve specifications, sampling instructions, test methods and other Quality Control procedures;

批准质量标准，抽样指令，测试方法和其他质量控制程序；

v.to approve and monitor any contract analysts;

批准并监督每一签约的分析人员；

vi.to check the maintenance of his department, premises and equipment;

检查其部门的环境和设备的维护状况；

vii.to ensure that the appropriate validation are done;

保证有关的验证已完成；

viii.to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

保证部门的人员接受必须的岗前和继续培训，且根据实际需要作相应调整。

2.7the heads of Production and Quality Control generally have some shared, or jointly exercised,

responsibilities relating to quality. These may include, subject to any national regulations:

生产和质控的负责人主要有以下与产品质量有关的相互分工或一起履行的职责，依不同国家法律法规有所不同，但可包括以下：

-the authorisation of written procedures and other documents, including amendments;

书面程序和其他文件以及修订文件的签署生效；

-the monitoring and control of the manufacturing environment;

生产环境的监测和控制；

-plant hygiene;

工厂卫生；

-process validation;

工艺验证；

-training;

培训；

-the approval and monitoring of suppliers of materials;

批准和监测物料供应商；

-the approval and monitoring of contract manufacturers;

批准和监测合同转包商；

-the designation and monitoring of storage conditions for materials and products;

物料和产品的仓储条件的规定和监测；

-the retention of records;

记录的保存；

-the monitoring of compliance with the requirements of Good Manufacturing Practice;

与生产质量管理规范要求的一致性的监测

-the inspection, investigation, and taking of samples, in order to monitor factors which may effect product quality.

检验、调查和取样以监测可能影响产品质量的因素。

Training

培训

2.8The manufacturer should provide training for all the personnel whose duties take them into

production areas or into control laboratories (including the technical, maintenance and

cleaning personnel), and for other personnel whose activities could affect the quality of the product.

生产者应提供培训，包括所有因职责之需进入生产或试验室区域的人员（包括技术人员、维护保养人员和清洁人员）以及其他人员其行为可能影响产品质量。

2.9Besides the basic training on the theory and practice of Good Manufacturing Practice, newly

recruited personnel should receive training appropriate to the duties assigned to them.

Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of the Production or the head of Quality Control, as appropriate. Training records should be kept.

除基本生产质量管理规范的原理和实际操作培训外，新员工应接受岗位职责的培训。提供继续培训，并定期评估培训的实际有效性。培训计划应是可获取的，有关计划应由生产或质控负责人批准。保存培训的记录。

2.10Personnel working in areas where contamination is hazard, e.g. cleaning areas or areas where

highly active, toxic, infectious or sensitising materials are handled, should be given special training.

在存在交叉污染风险的区域工作的人员，应接受专门培训；这些区域比如清洗间或处理高活性、毒性、传染性及光敏性物料的区域。

2.11Visitors or untrained personnel should, preferably, not be taken into the production and

quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.

参观人员或未经培训的人员最好不要进入生产和质控区域。如果无法避免，他们应事先接受相关培训，特别是对人员卫生和规定洁净衣的内容。他们应被密切监督。

2.12The concept of Quality Assurance and all the measures capable of improving its

understanding and implementation should be fully discussed during the training sessions.

质量保证的理念和所有能加强对其理解和实施的措施应在培训课程里一一讨论。Personnel Hygiene

人员卫生

2.13Detailed hygiene programmes should be established and adapted to the different needs within

the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene

programmes should be promoted by management and widely discussed during training sessions.

应建立具体的卫生程序并适应工厂的不同需要。这些程序应包括与健康、卫生行为和着装规范。每一进入生产和控制区域的人员应理解和严格执行这些程序。卫生程序应由管理层制订并在培训课程里进行广泛地讨论。

2.14All personnel should receive medical examination upon recruitment. It must be the

manufacturer’s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer’s knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personnel health.

所有人员在进入公司时应体检。生产者的职责之一是必须有相应指令保证其掌握与产品质量相关的健康知识。在第一次体检后，必要时仍应做职业健康和个人健康的检查。

2.15Steps should be taken to ensure as far as is practicable that no person affected by an

infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.

采取相关尽可能实行的措施保证患传染病或体表有伤口的员工不从事医药产品的生产。

2.16Every person entering the manufacturing areas should wear protective garments appropriate

to the operations to be carried out.

每一进入生产区的人员应根据程序穿着合适的保护洁净服。

2.17Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or

personnel medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden.

生产区应禁止任何吃东西、喝酒、咀嚼或吸烟的行为，禁止存放食品、饮料或香烟以及个人药物。总之，生产区或其他可能对产品造成不良影响的区域内的任何不卫生的行为都是禁止的。

2.18Direct contact should be avoided between the operator’s hands and the exposed product as

well as with any part of the equipment that comes into contact with the products.

操作人员的手不能直接接触产品以及接触产品表面的设备。

2.19Personnel should be instructed to use the hand-washing facilities.

应教导人员正确使用洗手设施。

2.20Any specific requirements for the manufacture of special groups of products, for example

sterile preparations, are covered in the annexes.

对特殊类别的产品如无菌制剂的具体生产要求，见附件。