Guidance Documents

Information about ISPE's Guidance Documents, white papers, Knowledge Briefs and other written technical guidance.

November 09, 2018
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Single-Use Technology . This Guide provides a roadmap for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. "Single-use...
October 25, 2018
ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...
April 16, 2018
ISPE announced the release of their latest Guide, ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities (Third Edition) . This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities...
iSpeak Blog
The GCP sector continues to experience significant global growth, even as the management of trials has become ever more complex and technology-driven. The current market size for global (bio)pharmaceutical research and development spending was an...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of December 2017. Start off your week by catching up on what the pharmaceutical industry was reading in December. FDA, Data Integrity, and the Dreaded Twenty-Five Words “Your...
iSpeak Blog
The ISPE GAMP® Guide: Records and Data Integrity provides you with principles and practical guidance on meeting current expectations for the management of GxP regulated records and data—ensuring that they are complete, consistent, secure, accurate, and...
iSpeak Blog
James W. McGlade Director, Project Management Longfellow Real Estate Partners, LLC Jim is a tireless volunteer who is always willing to jump in and lend a...
iSpeak Blog
The pharmaceutical, biopharmaceutical, and medical device industries have grown increasingly global in nature, a trend that will only continue.  How companies sell their products around the world and share information with both internal and external...
iSpeak Blog
It’s time for another edition of the Reading Roundup featuring the top blog posts from January 2017. Start off your weekend by kicking back and catching up on what the pharmaceutical industry was reading in January. Cast Your Vote for the 2016 Article...
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