ISPE Publications

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ISPE PublicationsISPE publications are invaluable resources for GMP best practices, technical information, emerging pharmaceutical industry trends, and industry and ISPE news.

Concept Papers

ISPE periodically offers concept papers authored by groups (such as ISPE’s Communities of Practice (CoP)) seeking to establish or clarify a concept, and to determine the level of interest in the concept discussed. The outcome may lead to a Guidance Document. See all Concept Papers

Discussion Papers

ISPE periodically offers discussion papers authored by groups seeking feedback on ideas or initiating debate. The outcome may lead to a concept paper or Guidance Document. See all Discussion Papers

GMP Mini Regulation Handbooks

These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines.See all Mini Regulation Handbooks

GMP Posters

ISPE offers a variety of inspirational posters that can be hung in common areas to remind employees of the importance of maintaining GMP standards. See all GMP Posters

Investigational Products (IP) Publications

ISPE's Clinical Trial Materials and Investigational Medicinal Products resources have been created to bring new investigational trial materials professionals quickly up to speed with the terms and related information they need to be successful in their field. See all IP Publications

Pest Control Handbook

This document addresses the fundamental concepts, policies, and practices for the control and management of pests in pharmaceutical manufacturing sites. Revision coming soon.

Pharmaceutical Engineering Knowledge Briefs

These concise summary documents provide easy-to-read overviews of industry-specific subjects. Knowledge Briefs are available at a variety of levels from Basic to Advanced. See all Knowledge Briefs

White Papers

ISPE offers several white papers developed to help educate the industry on specific topics and provide guidance to facilitate solutions. See all White Papers


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