Guidance Documents

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

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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...
Press Releases
05 June 2019
ISPE announced the release of their latest guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records . This guide features the expectations and requirements for data integrity and quality management in GMP facilities. Industry...
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Hear from two of the guide contributors, Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, on what you will take-away from purchasing this guide including practical and regulatory guidance...
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Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
Press Releases
28 March 2019
ISPE announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation . This guide provides professional insights for fundamental principles, process lifecycle approaches...
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...
Press Releases
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...
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
21 February 2018
ISPE announced the launch of their new online Guidance Documents Portal . For the first time, the entire library of Guides—including GAMP ® 5—can be accessed and searched online. In addition, the Society has made access to select ISPE Good Practice...