欧盟GMP（完整版）含附录，具体见目录

Gorgeous

Introduction
Part I - Basic Requirements for Medicinal Products
•    Chapter 1 Pharmaceutical Quality System  (66 KB)(Deadline for coming into operation: 31 January 2013)
Chapter 1 Quality Management (revision February 2008) (29 KB)
•    Chapter 2 Personnel (20 KB)
•    Chapter 3 Premise and Equipment (34 KB)
•    Chapter 4 Documentation (Revision January 2011) - Coming into operation by 30 June 2011 (33 KB)NEW
•    Chapter 5 Production (50 KB)
•    Chapter 6 Quality Control  (33 KB)
•    Chapter 7 on Outsourced activities (21 KB) (Deadline for coming into operation: 31 January 2013)
Chapter 7 Contract Manufacture and Analysis (22 KB)
•    Chapter 8 Complaints and Product Recall  (18 KB)
•    Chapter 9 Self Inspection (11 KB)
Part II - Basic Requirements for Active Substances used as Starting Materials
•    Basic requirements for active substances used as starting materials (452 KB)
Part III - GMP related documents
•    Site Master File  (33 KB)
•    Q9 Quality Risk Management  
•    Q10 Note for Guidance on Pharmaceutical Quality System  
•    MRA Batch Certificate (101 KB)
•    Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (40 KB)
Annexes
Table Eudralex
Annex 1    Manufacture of Sterile Medicinal Products  (122 KB)

Annex 2    Manufacture of Biological active substances and Medicinal Products for Human Use (171 KB) (Deadline for coming into operation: 31 January 2013)
Manufacture of Biological Medicinal Products for Human Use (30 KB)

Annex 3    Manufacture of Radiopharmaceuticals (68 KB)

Annex 4    Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products (14 KB)

Annex 5    Manufacture of Immunological Veterinary Medicinal Products (43 KB)

Annex 6    Manufacture of Medicinal Gases  (48 KB)

Annex 7    Manufacture of Herbal Medicinal Products (23 KB)

Annex 8    Sampling of Starting and Packaging Materials (20 KB)

Annex 9    Manufacture of Liquids, Creams and Ointments (13 KB)

Annex 10    Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation (17 KB)

Annex 11    Computerised Systems (revision January 2011)  (22 KB)

Annex 12    Use of Ionising Radiation in the Manufacture of Medicinal Products (50 KB)

Annex 13    Manufacture of Investigational Medicinal Products (67 KB)

Annex 14    Manufacture of Products derived from Human Blood or Human Plasma (50 KB) - May 2011

Annex 15    Qualification and validation  (136 KB)

Annex 16    Certification by a Qualified person and Batch Release (41 KB)   

Annex 17    Parametric Release (124 KB)

Annex 19    Reference and Retention Samples (24 KB)

Glossary
•    Glossary (27 KB)
Other documents related to GMP
•    Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures
•    Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) (94 KB)

补充内容 (2014-2-17 09:31):
http://ec.europa.eu/health/files ... fs-en/cap7en_en.pdf

lujiao330

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
可以直接在这个网站上下载的哦。
不过楼主整理好的用起来更方便。

凌空飞翔

英文版！有中文版吗？

Gorgeous

凌空飞翔 发表于 2013-1-10 11:59
英文版！有中文版吗？

这个真没有~~

jjb2005

英文原版？很给力!感谢分享！

制药设备

@piao0923@韩湘子 @GmpForEver 应该有用

liuqygood2005

多谢分享。

观沧海

{:soso_e181:}

伯乐

可惜看不懂:

jszy

谢谢楼主分享

无为

提供一个中文版就更好了{:soso_e113:}

youkudianying

谢谢分享                       

liu_20080101

看不懂，还是要支持一下

zeal602

谢谢楼主分享。。。。

地平线

我英语差，没看懂，楼主你教教吧！

言若

全英文的，看来要好好学习英语了！！！

轰天乌驹

十分感谢,谢谢分享

天长

要好好学习英语了

胜利者

谢谢分享

lslhcc

英文看不懂啊、、、求中文