应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 WHO. The 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 向39位WHO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 对39位WHO专家委员介绍制药准备的规格问题 对39位WHO专家委员介绍药业准备的规格问题 对39位WHO专家委员介绍药业准备的规格问题 | 24-28 October 2005 |
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Working document QAS/04.068/Rev.2 page 3
GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS
CONTENTS目录
| 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 |
天狗吃月亮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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