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...
Press Releases
17 January 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...
iSpeak
09 November 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...
Press Releases
25 October 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...
Press Releases
16 April 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...
Press Releases
20 July 2017
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) . This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management)...
iSpeak Blog
It’s time for another edition of the Reading Roundup featuring the top blog posts from March 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in March. Data Integrity and Your...
iSpeak Blog
Malik Belattar, chair of the ISPE Disposables Steering Committee and Pharma Biot’Expert’s representative, invites you to join the discussion about several important topics related to disposables. The ISPE Communities of Practice (CoP) has highlighted...
iSpeak Blog
Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), offers insight about what brought on the update and what core takeaways you’ll get from the new edition of this Guide. Key concepts of the OSD...
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...