API工艺合规检查指南

潇湘子 · 发表于 2013-3-14 08:15:24

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ACTIVE PHARMACEUTICAL INGREDIENT (API) PROCESS INSPECTION

Table of Contents
PART I - BACKGROUND .............................................................................................................4
General: ..............................................................................................................................4
Scope of APIs Covered by this Program: ........................................................................5
PART II - IMPLEMENTATION.....................................................................................................6
Objective:............................................................................................................................6
Program Management Instructions:................................................................................7
Inspection Planning: ..........................................................................................................8
Profile Classes: ...................................................................................................................8
Types of Inspections: .........................................................................................................9
PART III - INSPECTIONAL ..........................................................................................................9
Inspection Approaches: ...................................................................................................10
Full Inspection Option: .......................................................................................10
Abbreviated Inspection Option: .........................................................................11
Compliance Inspections: .....................................................................................12
Selecting Systems for Coverage:.....................................................................................12
Preparing the Inspection Strategy: ................................................................................12
Special Inspection Reporting Instructions: ...................................................................13
Special Instructions for Foreign Drug Inspections:......................................................14
PART IV – ANALYTICAL ..........................................................................................................15
PART V - REGULATORY/ADMINISTRATIVE STRATEGY..................................................15
PART VI - REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS.......................19
References: .......................................................................................................................19
Program Contacts:...........................................................................................................20
PART VII - CENTER RESPONSIBILITIES................................................................................21
APPENDIX A: Description of Each System and Areas of Coverage ............................22

琼台仙境 · 发表于 2013-3-14 08:24:29

{:soso_e100:}

youranzide · 发表于 2013-3-14 08:27:21

谢谢楼主分享

sunwng · 发表于 2013-3-14 08:28:44

{:soso_e109:}发个中文的行不

总统特使 · 发表于 2013-3-14 08:38:12

有中文的吗？？

liuqygood2005 · 发表于 2013-3-14 08:50:40

多谢分享。

windli · 发表于 2013-3-14 10:03:24

谢谢分享！！！！

缶極泰筙 · 发表于 2013-3-14 10:49:23

好东西啊学习了啊

lxf0556 · 发表于 2013-3-14 16:07:33

纯英文的，不耐===

李丁花 · 发表于 2013-3-15 09:17:44

有中文的吗？

开门-关门 · 发表于 2013-3-15 09:21:16

纯英文的看起来费劲啊，理解不了

潇湘子 · 发表于 2013-3-15 18:42:44

李丁花发表于 2013-3-15 09:17
有中文的吗？

暂时木有

334352444 · 发表于 2013-3-19 08:47:02

下载学习，谢谢分享

zzh908 · 发表于 2013-3-19 09:51:30

好资料，谢谢！

xz414123 · 发表于 2019-7-17 12:28:56

感谢学习下

小金库 · 发表于 2022-8-3 19:19:41

谢谢分享，学习

API工艺合规检查指南

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