Guidance Documents

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

APQ

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

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...

GAMP

GAMP 5 Guide 2nd Edition

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
Media & Press Releases

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

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...
ISPE Provides New Guidance on Continuous Manufacturing of Oral Solid Dosage Forms
Media & Press Releases

ISPE Provides New Guidance on Continuous Manufacturing of Oral Solid Dosage Forms

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...
APQ Guide: Change Management (CM) System
iSpeak Blog
New ISPE APQ Guide Helps Companies Improve Change Management Systems

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.

ISPE Provides New Guidance on Change Management Systems
Media & Press Releases

ISPE Provides New Guidance on Change Management Systems

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...
APQ

APQ Guide: Change Management (CM) System

The change management system is a fundamental element of the PQS described in ICH Q10. Effective change management enables quality improvement and ensures a continued state of control. The ISPE APQ Guide: Change Management System provides a quality management framework for assessing and advancing change management systems.
Video

Advancing Pharmaceutical Quality

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ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances...