Guidance Documents

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

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.
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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...
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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 process/facility attribute alignment and how that changes in the ATMP space.


 

Press Releases
21 January 2022
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) . This Guide was written to meet changing industry practices, as global...
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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 Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...

Press Releases
09 December 2021
ISPE announced the release of the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy , a first-of-its-kind guide about the development and design of manufacturing facilities for ATMPs. ATMP therapies include cells...
Press Releases
05 November 2021
ISPE announces the release of its latest Guide in November 2021, ISPE Good Practice Guide: Good Engineering Practice (Second Edition) . The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under...
Published: June 2019 Pages: 212 Table of Contents Special Pricing for Emerging Economies The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach