[ISPE] All guide Documents Catalog

paul3122 · 发表于 2013-8-18 12:57:04

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http://www.ispe.org/index.php/ci_id/4351/la_id/1.htm
GAMP[size=0.85em]® 5

[size=1.3em]GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance.

[size=1.3em]GAMP 5:[size=1.3em]A Risk-Based Approach to Compliant GxP Computerized Systems

GAMP[size=0.85em]® Good Practice Guides

[size=1.3em]Reflecting current regulatory expectations and good practices, the the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.

[size=1.3em]A Risk-Based Approach to Calibration Management (Second Edition)
[size=1.3em]A Risk-Based Approach to Electronic Records and Signatures
[size=1.3em]A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
[size=1.3em]A Risk-Based Approach to GxP Process Control Systems (Second Edition)
[size=1.3em]A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5
[size=1.3em]A Risk-Based Approach to Testing of GxP Systems (Second Edition)
[size=1.3em]Electronic Data Archiving
[size=1.3em]Global Information Systems Control and Compliance
[size=1.3em]IT Infrastructure Control and Compliance
[size=1.3em]Legacy Systems
[size=1.3em]Manufacturing Execution Systems – A Strategic and Program Management Approach
[size=1.3em]GAMP Good Practice Guides Under Development

ISPE Baseline[size=0.85em]® Pharmaceutical Engineering Guides for New and Renovated Facilities

[size=1.3em]Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.

[size=1.3em]Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals
[size=1.3em]Volume 2: Oral Solid Dosage Forms (Second Edition)
[size=1.3em]Volume 3: Sterile Product Manufacturing Facilities (Second Edition)
[size=1.3em]Volume 4: Water and Steam Systems (Second Edition)
[size=1.3em]Volume 5: Commissioning and Qualification
[size=1.3em]Volume 6: Biopharmaceutical Manufacturing Facilities
[size=1.3em]Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
[size=1.3em]Baseline Guides Under Development

ISPE Baseline[size=0.85em]® Pharmaceutical Engineering Guides for New and Renovated Facilities

[size=1.3em]Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.

[size=1.3em]Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals
[size=1.3em]Volume 2: Oral Solid Dosage Forms (Second Edition)
[size=1.3em]Volume 3: Sterile Product Manufacturing Facilities (Second Edition)
[size=1.3em]Volume 4: Water and Steam Systems (Second Edition)
[size=1.3em]Volume 5: Commissioning and Qualification
[size=1.3em]Volume 6: Biopharmaceutical Manufacturing Facilities
[size=1.3em]Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
[size=1.3em]Baseline Guides Under Development

ISPE Guides

[size=1.3em]ISPE’s Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance.

[size=1.3em]ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
[size=1.3em]ISPE Guides Under Development

ISPE Good Practice Guides

[size=1.3em]ISPE Good Practice Guides (GPGs) provide information or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.

[size=1.3em]ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
[size=1.3em]ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
[size=1.3em]ISPE Good Practice Guide: Booklet Labels
[size=1.3em]ISPE Good Practice Guide: Cold Chain Management
[size=1.3em]ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems
[size=1.3em]ISPE Good Practice Guide: Comparator Management
[size=1.3em]ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
[size=1.3em]ISPE Good Practice Guide: Good Engineering Practice
[size=1.3em]ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
[size=1.3em]ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
[size=1.3em]ISPE Good Practice Guide: Interactive Response Technology
[size=1.3em]ISPE Good Practice Guide: Maintenance
[size=1.3em]ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water System
[size=1.3em]ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
[size=1.3em]ISPE Good Practice Guide: Process Gases
[size=1.3em]ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry
[size=1.3em]ISPE Good Practice Guide: Quality Laboratory Facilities
[size=1.3em]ISPE Good Practice Guides Under Development

PQLI[size=0.85em]® Guides

[size=1.3em]Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.

http://www.ispe.org/multimedia/p ... ublicationsCatalog/

paul3122 · 发表于 2013-8-18 12:59:45

抢个沙发，这些书籍中：
论坛已经有一部分了：
水与蒸汽系统，工艺用气系统，固体制剂，无菌制剂等……
再接再厉哦~~

yan1302 · 发表于 2013-8-19 09:30:20

哪个战友有这本啊？ A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

syhorchid · 发表于 2013-8-19 09:31:54

地板

cylpmw · 发表于 2013-9-27 16:47:50

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胜利者 · 发表于 2013-9-28 20:27:50

谁能分享ISPE正版PDF的密码和水印解除？

ZhAng_超_~ · 发表于 2013-10-18 09:36:46

请问楼主，你的衔接是很好的，但是我点击了，去了，是叫我买书啊，否则看不了，下载不了，请问楼主有下载的分享吗？

sony8086 · 发表于 2013-10-18 15:51:13

解密去水印，简单了，有软件的

luislu · 发表于 2017-5-11 16:55:25

这点进去都能下载吗？

meiyududu · 发表于 2017-5-11 20:39:13

谢谢分享。。。

魑魅 · 发表于 2018-2-7 14:02:54

下载收费的，就是ISPE的官网

预知子 · 发表于 2018-2-23 13:37:38

收集目录来了

jane_zj · 发表于 2018-4-13 13:06:59

先收集目录，再慢慢找资源吧

小金库 · 发表于 2022-8-3 19:06:12

感谢分享

[ISPE] All guide Documents Catalog

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