WHO_TRS_961（15个附录翻译的集中）

小付FY

周末查资料，索性就把这15个附录，论坛有的，集中在一起了，方便大家查阅！

1, 4, 6 ,8 ,11 ,15 中文翻译暂时没有（主要是Julia大神翻译的），其他的都全了。（英文是全的）
至于目录就用“有道”大概翻译了下，见下信息（6个没有翻译中文的，有道翻译的目录可能不准确）

Annex 1
Release procedure of International Chemical Reference Substances
附件 1：国际化学参考附件
Annex 2
WHO good practices for pharmaceutical microbiology laboratories
世界卫生组织药品微生物实验室管理规范
Annex 3
WHO good manufacturing practices: main principles for pharmaceutical products
WHO GMP 主要原理
Annex 4
WHO good manufacturing practices for blood establishments (jointly with the
Expert Committee on Biological Standardization)
血液制品良好管理规范
Annex 5
WHO guidelines on good manufacturing practices for heating, ventilation and
air-conditioning systems for non-sterile pharmaceutical dosage forms
非无菌制剂的加热通风和空调系统的生产质量管理规范的补充指导原则
Annex 6
WHO good manufacturing practices for sterile pharmaceutical products
无菌药品良好管理规范
Annex 7
WHO guidelines on transfer of technology in pharmaceutical manufacturing
WHO 药品生产技术转移的指导原则
Annex 8
Good pharmacy practice: standards for quality of pharmacy services (joint
FIP/WHO)
药房服务质量标准良好管理规范
Annex 9
Model guidance for the storage and transport of time- and temperature-sensitive
pharmaceutical products (jointly with the Expert Committee on Biological
Standardization)
时间温度敏感的药物贮运指南
Annex 10
Procedure for prequalification of pharmaceutical products vi
药品的预认证程序
Annex 11
Guidelines on submission of documentation for prequalification of innovator
finished pharmaceutical products approved by stringent regulatory authorities
提交资格预审文件的指南
创新者药物成品经过严格的监管当局批准
Annex 12
Prequalification of quality control laboratories. Procedure for assessing the
acceptability, in principle, of quality control laboratories for use by United
Nations agencies
化验室预确认程序
Annex 13
WHO guidelines for preparing a laboratory information file
世界卫生组织准备实验室信息档案的指导原则
Annex 14
WHO guidelines for drafting a site master file
工厂主文件准备指南
Annex 15
Guidelines on submission of documentation for a multisource (generic) finished
product: general format: preparation of product dossiers in common technical
document format
指南提交的文档源(通用)成品:一般格式:
制备产品技术文档格式档案共同之处

麦田.守望

Annex 5 Technical supplements to Model guidance for the storage and transport of time‑ and temperature‑sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011), Annex 9 属于2015年第49号报告（无内容？！）。发的翻译稿是草案（QAS）哦。

Supplement 1 Selecting sites for storage facilities
Supplement 2 Design and procurement of storage facilities
Supplement 3 Estimating the capacity of storage facilities
Supplement 4 Building security and fre protection
Supplement 5 Maintenance of storage facilities
Supplement 6 Temperature and humidity monitoring systems for fxed storage areas
Supplement 7 Qualifcation of temperature-controlled storage areas
Supplement 8 Temperature mapping of storage areas
Supplement 9 Maintenance of refrigeration equipment
Supplement 10 Checking the accuracy of temperature control and monitoring devices
Supplement 11 Qualifcation of refrigerated road vehicles
Supplement 12 Temperature-controlled transport operations by road and by air
Supplement 13 Qualifcation of shipping containers
Supplement 14 Transport route profling qualifcation
Supplement 15 Temperature and humidity monitoring systems for transport operations
Supplement 16 Environmental management of refrigeration equipment

http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/


补充内容 (2017-2-28 13:49):
做冷链运输验证可以参考

麦田.守望

lzw0813 发表于 2021-7-30 20:09
链接打不开

https://www.who.int/teams/health ... elines/distribution
附件是网页快照

zyychen

感谢分享！

zcwzy

功德无量谢谢呵呵呵。。

pineweek

多谢分享，拿去学习了

mql6863

谢谢分享。

adou

谢谢分享，认真学习！

lingzhi

谢谢分享啊

丈文水鹿

谢谢楼主分享

小付FY

cheng9gong 发表于 2016-8-7 09:20
解压后打不开啊

要一起解压才行

selinahan

谢谢分享！

1982tao

谢谢分享。

胜利者

谢谢

jasmine

谢谢楼主的分享

safsaf

这几天在研究WHO，谢谢分享

scslk0045

谢谢分享，认真学习！

yxds8g

谢谢分享。

wuyxwuyx

谢谢分享..........

北重楼

蛮全的，慢慢学习一下

cheng9gong

解压后打不开啊