Guidance Documents

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

June 13, 2018
Ten years after its publication, the ISPE GAMP ® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP computerized system compliance and validation for companies and suppliers and...
May 31, 2018
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 est...
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 an...
March 02, 2018
On Monday, 30 October, Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, and ISPE OSD Baseline ® Guide Steering Committee Manager, led “Understanding the Architectural, HVAC, and Risk Management Considerations for OSD Facilities,”...
January 24, 2018
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 “Yo...
April 20, 2017
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,...
April 03, 2017
James (Jim) McGlade Science Client Leader BHDP Architecture Jim is a tireless volunteer who is always willing to jump in and lend a hand, whether it’s presenting an award, moderating a session, or taking on a major project like helping to write a gui...
March 15, 2017
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 c...
February 01, 2017
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 Articl...
January 11, 2017
The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases has just been published and is a “first of its kind” document to address an issue that has been costing the pharmaceutical industry millions of dollars every ye...
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