Guidance Documents

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

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Maintaining the principles and framework of the first edition published in 2008, the much-anticipated ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition): Provides updates to...
Affiliates/Chapters News & Press Releases
11 October 2022
More than 80 delegates joined GAMP CoP Benelux event on October 11th, hosted by Pivot Park - Oss (NL) and sponsored by Vivenics. Data integrity in new technologies was discussed during interactive roundtable discussions. Experts from industry told...
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of the PQS described in ICH Q10. An effective PPPQMS ensures a state of control is maintained and facilitates continual improvement. The ISPE APQ Guide: PPPQMS provides a quality management framework for assessing and advancing an organization’s PPPQMS.
iSpeak Blog

As the benefits of continuous manufacturing became more apparent in the pharmaceutical industry, companies looked for ways to incorporate the technology into their manufacturing processes. In 2017 The ISPE Oral Solid Dosage (OSD) Community of Practice (CoP) formed a working team to advance the use of continuous manufacturing in the pharmaceutical industry and to increase the long-term...

Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.
iSpeak Blog

For nearly a century, production of Water for Injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies. In 2017, the European Pharmacopoeia joined the US, Japan, and many other regulatory...

Press Releases
13 June 2022
ISPE announced the release of the ISPE Good Practice Guide: Membrane-Based Water for Injection Systems. This Guide provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based water for injection (WFI) systems...
Press Releases
03 May 2022
ISPE announced the release of the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms . This Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment...
iSpeak Blog

What is the current state of your organization’s Change Management (CM) System? The effective management of change throughout the product lifecycle enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency.

Press Releases
30 March 2022
ISPE announced the release of the ISPE APQ Guide: Change Management System . This Guide provides a quality management framework for assessing and advancing change management (CM) system maturity level by evaluating documentation, change/scope...