蒲公英独家网络首发：ISPE Baseline Vol 7-MaPP

库拉赛尅伊姬谷

     继昨天发布蒲公英独家网络首发重磅资料：ISPE baseline volume4-Water and Steam System 2 之后的又一重磅资料，也是蒲友在找的资料，ISPE Baseline Vol 7-MaPP是ISPE有关风险管理的指南，此版本为电子扫描版，清晰度还可以，经过技术处理可以自由复制，有需要的蒲友可以自行下载，如果需要中文版本的，我们要寄希望于论坛啦@蒲公英



Table of Contents
1 Introduction ..................................................................... .................................... .... ............ 7
1.1 Approach to Identify Highly Hazardous Drugs .................................................................... ......................... 8
1.2 Risk ManagemenUAssessment Model to Address the Controls to Comply with 21 CFR 211.42(c) ............ 8
1.3 How the Approach Fits Into Cleaning Va lidation .... ...... ...... ............................................................ ...... ........ 9
1.4 Background ....... .... ..................... ....................................................... .................................... ............. ..... .. ... 9
1.5 Scope of this Guide .. .... .......... .................................................................................................................... 10
1.6 Current Situation ................................... .......... ... ...................... ....................................... ................ .. ....... .. 1 0
1.7 How to Use this Guide .............................. .................... .. .. ...... ............. .............. .............. .... .......... ............ 11
2 Concepts and Regulatory Philosophy ............................................................................ 13
2.1 Overview of the Risk Management Approach .. ................. ............... .... ................ .. .. .. ........ ......... ... ............ 14
2.2 Acceptable Risk ... ......... .. .. .. ........ ....................................... .. ... ....... ........ ......... ...... ....... .... ..... .. ..... ......... ..... 15
2.3 The GMP and Industrial Hygiene Balance ............ .. .. .. .............. .. .................... ......... .. ............. .. ........ ......... 16
3 Quality System Requirements ......................................................................................... 19
3.1 GxP Quality Policies ....................................................................................................................... .. ......... 19
3.2 GxP Quality Standards ......... ... ..... .. ........... ..... ...... ... ... ........... ... .. .................. .. ... ............................ .. .......... 20
3.3 Gap Analysis ......... ... ....................... ........... ..... ...... .. ....... .... .... ...... ........... ...... ....... .... .. ................................ 20
3.4 Auditing of Quality Systems .... ......................................... ...... .................................................................... 20
3.5 Application to Cross-Contamination ...... ... .... ..... ....... .... ... .. .............. ...... .............................. .. ........ ............. 20
3.6 The Logic Diagram .... ..... .......... ............ .... ........ ... ..... .. ... .... .. ........ .......... ................ .. .............. ... ..... ......... .... 21
4 Risk Assessment ....................... ....................................................................... ................ 31
5 Risk Identification ................................................................. ............................................ 33
5.1 Definition of Hazard ........................... .. .......... .............................................. .. .. ........................... ............... 33
5.2 Hazard Continuum and Prioritization for Risk Assessment.. .. .. .......... ... ...... .. ............................................. 34
5.3 Establishing Health-Based Exposure Limits ............................................ ...................... .. .......... .. .. ............ 35
5.4 Setting Health-Based Safety Thresholds/Acceptance Limits ........ ....... ................. .. .. ..... .. .... ......... .. ...... ..... 42
5.5 Setting Occupational Exposure Limits (OELs) ............... .............. ........ .. ... ............ ... ...... .. ........ ... ... ....... ..... 46
6 Risk Analysis .................. .................. ............. .................................................................... 47
6.1 Holistic Approach to Risk Analysis ................................................. .. ................ ......... ........................... .. .... 48
6.2 Tools ............ .... ..... ........... .......... .......... ............. .... ........... .................. ... ...................................................... 48
6.3 Routes for Cross-Contamination ...................................................................... ... ... .... .......... .... ....... ..... .. .... 50
6.4 Probability of Occurrence ....... ........... ...... ........ .... .................... .................... ........ .......... ........... ....... ... .... .... 55
6.5 Product Exposure Risk in Non-Product Contact Areas ....... .. ..... .. .............................................................. 60
6.6 Detection ........... ............. ... ...................................................... ....................... ..... .... ... ... ................... ... .. ..... 61
7 Risk Evaluation ................................................................................................................. 63
7.1 Cleaning Process Performance Capability ........................................... ....................... .. ............................ 64
7.2 Cleaning Evaluation for New Products .. ......... ........... ...... ........... .... ..... .. ....................... ........................... .. 64
7.3 Residue on Non-Product Contact Surfaces ...... ... ......................... ...... ............................. ... ....................... 64
8 Risk Control. ..................................................................... ................ ............ ..................... 67
8.1 Holi stically Balanced Approach ..... ...... .......... .. ....... ............. .......... ........... ....................... .......... ..... .......... .. 68
9 Risk Reduction .................................................................................................................. 71
9.1 Hierarchy of Risk Reduction ...................................................................................................................... 72
9.2 Risk Reduction: Routes of Exposure ...................................... .... ............................................................... 73
9.3 The Role of Pharmaceutical Research and Development in Risk Reduction .. .. ...... .................................. 76
9.4 Process and Related Technologies ................................................... ................. .. .. ... .. .. ............................. 77
9.5 The Role of Facility Engineering in Risk Reduction .......................... .......... .... ......................................... .. 79
9.6 HVAC .. .............................................................................. ....... ...... .... .......................................... ... ... ........ 84
9.7 Containment Related Technologies .. ........ ..... ...... ............... ..... ................. .................. ..... .. ........ ..... ........... 85
9.8 Personal Protective Equipment (PPE) and Gowning ............................... .. .. ...... .. ......... ............ .... ............. 86
10 Risk Acceptance ............................................................................................................... 87
11 Risk Management Tools ................................................................................................... 89
11 .1 Risk Ranking or Risk Matrix ....................................................................................................................... 90
11 .2 Failure Mode and Effects Analysis (FMEA) ............................................................................................... 91
12 Risk Review ....................................................................................................................... 95
13 Risk Communication ............................ ............................................................................ 97
13.1 Summary Document Template ....................................................................... ........ .................................... 98
14 Appendix 1- Risk-MaPP Application Examples .......................................................... 101
14.1 lntroduction .. ....................... ........... ........... ..... ....... .............. .......... ................ .. ......... ................................ 101
14.2 Scenario 1 (Obviously Acceptable) .... .............................. ......... ... ........ ..................................... ............... 102
14.3 Scenario 2 (Obviously Unacceptable) ............................................... ............... .. ... .. .......................... ....... 105
14.4 Scenario 3 (Apparently Acceptable (but was not)) .............................................................. ............ .. .... ... 107
14.5 Scenario 4 (Apparently Unacceptable (but was)) ..................... ............... .. ....................................... .. ..... 117
14.6 Logic Diagram ............................................................................................. ............................. .. .............. 128
15 Appendix 2- Bibliography ............................................................................................. 129
15.1 References ............................................................................................................................................... 129
15.2 Reading List ......................................................................... .. .................................................................. 133
16 Appendix 3 - Glossary ................................................................................................... 137
16.1 Abbreviations and Acronyms .. ................................................................................................................. 137
16.2 Definitions .. ................... .... ............................................................. .... ......... ... .. ............. ... ........................ 141

附件下载：
ISPE Baseline Vol 7-MaPP.pdf (35.14 MB, 下载次数: 7185, 售价: 8 金币)

2013-6-6 11:15 上传

点击文件名下载附件

友情链接：
蒲公英独家网络首发重磅资料：ISPE baseline volume4-Water and Steam System 2
https://www.ouryao.com/thread-137876-1-1.html

麦田.守望

ISPE Baseline Volume 7
Risk-Based Manufacture of Pharmaceutical Products
First Edition / September 2010
来自：Pharmout GMP Library（已关闭）


补充内容 (2016-10-24 13:25):
与楼主的不是同一版本

paul3122

沙发沙发啦~~!!!第一次哦!

库拉赛尅伊姬谷

比我还快{:soso_e127:}

蒲公英

蒲公英在此，请与我联系，将中文版发送到邮箱chinapat@foxmail.com     我们会与您配合完成，感谢支持

库拉赛尅伊姬谷

蒲公英 发表于 2013-6-6 11:26
蒲公英在此，请与我联系，将中文版发送到邮箱     我们会与您配合完成，感谢支持

额 本人也在祈求中文版本，把英文版本的传上来共享，也是希望借助论坛的力量，人多力量大嘛

paul3122

库拉赛尅伊姬谷 发表于 2013-6-6 11:24
比我还快

这两天论坛真是重磅不断啊~!!
还在期待哦~~ISPE还有很多书籍！比如固体制剂和API，还有Process gas~~

野性之吻

真好 要是有中文版的就好了

毒手药王

要是有中文版的就好了，支持首发

dml8888

好东东，收藏了！！

吱吱

楼主辛苦，下载收藏

红茶.

不是人，是神啊。。。。。。。。。。

windli

thanks a lot

开羽

蒲公英越来越壮大了，这两天真是惊喜不断。

helloyou

太好了，非常感谢楼主！！非常感谢！

helloyou

我就喜欢原版的书，没有翻译！看起来爽！

helloyou

原版的 ！好呀！

paullix

下来学习，谢谢

风之惑2012

很不错的资料，感谢分享~

pgylac2

感谢分享  很好的资料

bluekimi

这样的书真是值得收藏 多谢楼主分享