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Because ISPE draws on so many professionals from throughout the pharmaceutical industry, one can learn from those people during meetings, conferences, and training courses. That is what's great about ISPE.
Robert Tribe, Past Chairman
PIC/S, Australia
Watch the Video:
True Stories: What it means to be an ISPE Member - (WMV, 16 MB)
(Click to begin, or right-click to download and view later)
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Publications |
ISPE offers you the strategic and tactical resources you need to stay ahead. ISPE Technical Publications are indispensable references for global regulators as well as industry professionals.
Our technical publications take the collective knowledge of leading thinkers on manufacturing best practices, regulatory compliance and international trends and package it in an easy-to-use format you can easily apply to your work.
Select ISPE publications available for immediate download. Learn more...
Publications Overview
| Pharmaceutical Engineering® |
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Considered to be the number-one member benefit, the Society's esteemed magazine is published bi-monthly for members-only. Feature articles provide practical application and specification information on the design, construction, supervision, and maintenance of process equipment, plant systems, instrumentation, and facilities. Departments and features include technical articles, case studies, industry and people, global regulatory news, technology trends, validation, ISPE update, industry interviews, new products and literature, classified advertising as well as advertising by leading suppliers to healthcare manufacturers.
 Indicates content available to ISPE Members only.
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| Journal of Pharmaceutical Innovation |
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The Journal of Pharmaceutical Innovation is a new, international scientific peer-reviewed Journal intended for the publication of research and review manuscripts emphasizing new and innovative methods and techniques used by pharmaceutical professionals serving all aspects of the industry including Manufacturing, Applied Pharmaceutical Science and Technology in Process and Product Understanding and Control.
 Indicates content available to ISPE Members only.
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| ISPEAK® |
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ISPE's Members-only electronic newsletter features regulatory news, as well as information on upcoming ISPE events, local Chapter and international Affiliate activities, professional opportunities and Member news.
Archives of the printed version of ISPEAK, which was discontinued January 2006, are available for Members only.
Indicates content available to ISPE Members only.
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| Baseline® Pharmaceutical Engineering Guides |
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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. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. Additionally, they address GMP and non-GMP regulations and detail facility commissioning and qualification.
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| GAMP® Publications |
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Reflecting current regulatory expectations and good practices, the GAMP 5 Guide and the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.
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| ISPE Good Practice Guides (GPGs) |
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ISPE Good Practice Guides (GPGs) provide information or advise 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. GPGs address technical areas related to facilities and pharmaceutical manufacturing, and may highlight topics that propose how to meet the intent of a specific aspect of a GMP.
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| CPIPSM Study Guide |
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| The Study Guide provides the CPIP applicant with a detailed description of the knowledge elements that will be included in the CPIP examination.
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| Clinical Trial & Investigational Products Publications |
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ISPE's Clinical Trial Materials and Investigational Medicinal Products resources have been created to familiarize new investigational trial materials professionals with the terms and related information they need to be successful in their field. These are excellent tools to bring employees up to speed quickly and efficiently - saving your company valuable resources. They also serve as useful references for experienced professionals. As many US pharmaceutical and biotechnology companies provide clinical trial materials throughout the world, it is imperative to understand other country regulations.
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| GMP Products |
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The GMP Institute (GMPI), founded in 1977 to help companies comply with FDA's GMP regulations, was acquired by ISPE in 2000. The philosophy of the GMPI is simple - GMP makes good business sense because it helps a company to implement practices assuring the quality of their products. The products listed in this section are original to the GMP Institute.
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| Other Technical Publications |
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Informa Healthcare Publications
ISPE Members receive a 20 percent discount on publications from Informa Healthcare and its affiliated publishers, Marcel Dekker and CRC Press Publications.
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(PDF, 559 KB)
