Guidance Documents

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

iSpeak Blog
The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
January 17, 2019
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition . This Guide provides industry good practices for successful and efficient execution of technology transfer projects. “Transfer of...
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...
December 09, 2015
What you need to know and how to apply it! Use promo code 2015YearEnd on or before 15 January 2016 during check out to claim your special discount on the bound versions of these ISPE Guidance Documents : Baseline ® Guide: Active Pharmaceutical...
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...