FDA无菌工艺检查STERILE DRUG PROCESS INSPECTIONS

潇湘子

FDA 2012年11月新发布执行的文件哦：DRUG QUALITY ASSURANCE——STERILE DRUG PROCESS INSPECTIONS

TABLE OF CONTENTS
PART I BACKGROUND...................................................................................................4
PART II IMPLEMENTATION.............................................................................................5
2.1 Objective.......................................................................................................5
2.2 Program Management Instructions..............................................................5
A. Strategy...............................................................................................5
B. Inspection Planning.............................................................................6
C. Profile Reporting.................................................................................6
PART III INSPECTIONAL...................................................................................................7
3.1 Types of Sterilization....................................................................................7
A. Terminal sterilization...........................................................................7
B. Aseptic processing..............................................................................7
3.2 Reporting......................................................................................................8
3.3 Inspection Approaches.................................................................................9
3.4 System Inspection Coverage.....................................................................11
3.5 Quality System...........................................................................................11
3.6 Facilities and Equipment System...............................................................13
A. Facilities............................................................................................13
B. Equipment.........................................................................................14
3.7 Materials System........................................................................................19
3.8 Production System.....................................................................................21
3.9 Packaging and Labeling System................................................................27
3.10 Laboratory Control System.........................................................................27
3.11 Sampling.....................................................................................................29
PART IV ANALYTICAL.....................................................................................................30
PART V REGULATORY/ADMINISTRATIVE STRATEGY..............................................31
PART VI REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS...................33
6.1 References.................................................................................................33
6.2 Attachments................................................................................................34
6.2 Contacts.....................................................................................................34
PART VII CENTER RESPONSIBILITIES..........................................................................36
ATTACHMENT A .................................................................................................................A

zdlxcb

谢谢分享

liuqygood2005

学习下，多谢

红茶.

FDA又更新好东西。

胜利者

这个可以www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125409.pdf

smalltrees

谢谢分享。

youngzhou

多谢楼主分享。

zzh908

谢谢了。下载了。

devoter2000

谢谢分享，下载学习

黎明曙光

这个有中文版吗目前

litao8702

好东西，对C&Q很有指导意义

小胖子和小瘦子

真是好东西啊

小金库

谢谢楼主大公无私分享！