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...
Guidance Docs
The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.
Guidance Docs
03 May 2022
News & Press Releases
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.
Guidance Docs
This Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment requirements for each system to function as part of an integrated process train. While most of the units are well-understood and used in batch manufacturing, the Guide considers the changes in physical and automation requirements that will allow each unit to work in concert as part of a successful continuous manufacturing platform. Operations unique to CM, loss-in-weight feeding and continuous blending, are discussed, including how these systems affect upstream and downstream operations.
Guidance Docs
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
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...
iSpeak Blog
The ATMPs - Autologous Cell Therapy Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current...
iSpeak Blog
ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in December. The international team of experts working on the revision felt it was time to update the Guide due to the increasing complexity of...
iSpeak Blog
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical...