Guidance Documents

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

Video

GAMP® 5 Guide, 2nd Edition: Why It's Needed

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...
Video

GAMP® 5 Guide, 2nd Edition: What's News

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...
Video

GAMP® 5 Guide, 2nd Edition: Top Takeaways

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...
GAMP 5 2nd Edition
Guidance Documents

Launch new GAMP5 2nd Edition in Benelux!

11 October 2022
News & Press Releases
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...
Guidance Documents
Guidance Docs

APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

APQ
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.
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
iSpeak Blog
Should Your Company Switch to Continuous Manufacturing?

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...

Guidance Documents
Guidance Docs

GAMP 5 Guide 2nd Edition

GAMP
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.
Is a Membrane-Based Water for Injection System Right for Your Facility?
iSpeak Blog
Is a Membrane-Based Water for Injection System Right for Your Facility?

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...

ISPE Provides New Guidance on Membrane-Based Water for Injection Systems
Guidance Documents

ISPE Provides New Guidance on Membrane-Based Water for Injection Systems

13 June 2022
News & Press Releases
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...