Guidance Documents

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

News & Press Releases
14 July 2020
ISPE announced the release of its latest guide, I SPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It . The Guide was cultivated by leading experts to help pharmaceutical organizations achieve and...
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The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing...
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Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process...
News & Press Releases
03 February 2020
ISPE announced the release of its latest guide, ISPE Good Practice Guide: HVAC & Process Equipment Air Filters . This guide provides readers with a better understanding of current technologies and their application as it relates to current...
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A Road Map to Implement Single-Use Technology Single-use technology (SUT) has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly...
News & Press Releases
23 October 2019
ISPE announced the release of its latest guide, ISPE Baseline® Guide: Water and Steam Systems (Third Edition) . This guide provides in-depth guidance for the design, construction, operation, and lifecycle management of water and steam systems...
News & Press Releases
01 July 2019
ISPE announced the release of their latest guide, ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) . This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and...
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Calibration Management Attachments