GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS

更新时间:2023-08-03 11:12:31 阅读: 评论:0

Working document QAS/04.068/Rev.2
RESTRICTED
WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE
GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS
药制品良好的经销规则
This document has followed the steps given in the schedule on page 2 herein. It竞选班长 has been very widely distributed and numerous comments have been incorporated.
此文件遵循第二页给出的步骤。此文件已被广泛发布且融合了大量的评论
Plea address any comments and/or corrections you may have on thereon to
Dr S. Kopp, Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland, fax: (+41 22) 791 4730
or e-mail: kopps@who.int, with a copy to bonnyw@who.int, by 20 October 2005.
请把您的评论或者修正意见发给Dr S. Kopp,地址为Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland,传真为(+41 22) 791 4730,邮箱为:。同时还要在2005年10月20日前把上述邮件发到bonnyw@who.int,
© World Health Organization 2005
All rights rerved.
This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft.  The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations象棋古谱concerned staff and member organizations) without the permission of WHOThe draft should not be displayed on any website.
Plea nd any 旗帜鲜明request for permission to:
Dr Sabine Kopp, Quality Assurance & Safety: Medicines (QSM), Department of Medicines Policy and Standards
(PSM), World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730;    e-mails:  kopps@who.int; bonnyw@who.int
The designations employed and the prentation of the material in this draft do not imp喝醋有什么好处ly
the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreeh3c配置命令ment.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endord or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
The World Health Organization does not warrant that the information contained in this draft is complete and correct and shall not be liable for any damages incurred as a result of its u.

Working document QAS/04.068/Rev.2 page 2
SCHEDULE FOR THE ADOPTION PROCESS OF DOCUMENT QAS/04.068/REV.2: GOOD DISTRIBUTION PRACTICES (GDP)
FOR PHARMACEUTICAL PRODUCTS
文件的采用过程计划
药制品的良好经销规则
早安正能量问候语
Deadline截止日
First draft prepared and mailed for comments
撰写首稿后将其邮寄以获取评论
January 2004
Deadline for receipt of comments
接受评论的截止日
31 March 2004
Collation of comments
收集评论
May 2004
Revision of draft document
修订草拟文件
October 2004
Prentation to Thirty-ninth WHO Expert Committee on
Specifications for Pharmaceutical Preparations
39WHO专家委员介绍制药准备的规格问题
25-29 October 2004
Mailing of first revision for comment
邮寄首个修订本以获取评论
March 2005
Collation of comments
收集评论
April 2005
Discussion in consultation
共同谈论协商
May 2005
Revision of draft document
修订草拟文件
June-July 2005
Mailing of cond revision for comment
邮寄第二次修订本以获取评论
September 2005
Collation of comments
收集评论
September-October 2005
Prentation to Fortieth WHO Expert Committee on
Specifications for Pharmaceutical Preparations
39WHO专家委员介绍制药准备的规格问题
39WHO专家委员介绍药业准备的规格问题
39WHO专家委员介绍药业准备的规格问题
24-28 October 2005

Working document QAS/04.068/Rev.2 page 3
GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS
CONTENTS目录
天狗吃月亮
page
1.
Introduction介绍……………………………………………………
3
2.
Scope of the document文件范围……………………………...…
5
3.
Glossary术语……………………………………………………….
5
4.
Organization and management 组织和管理…………………..
10
5.
Personnel人员…………………………………………………...
11
6.
Quality management质量管理……………………………………….
12
7.
Premis, warehousing and storage经营场地,储仓…..
13
8.
Vehicles and equipment 车辆和设备………………………………
16
9.
Containers and container labelling容器和容器标签…………………
17
10.
Dispatch 分派……………………………………………………
18
11.
Transportation 凹凸不平and products in transit ……………………………..
20
12.
Documentation ……………………………………………………..
21
13.
Repackaging and relabelling ……………………………………….
23
14.
Complaints …………………………………………………………
23
15.
Recalls ……………………………………………………………...
23
16.
Rejected and returned products …………………………………….
24
17.
Counterfeit pharmaceutical products ……………………………….
25
18.
Importation ………………………………………………………….
25
19.
Contract activities …………………………………………………..
26
20.
Self-inspection ……………………………………………………...
26
21.
Bibliography ………………………………………………………..
26

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