Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations.
ISPE has more than 65 Guidance Documents covering a wide variety of topics. Below are the coming soon and latest Guides.
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Coming Soon: December 2022
Good Practice Guide: Containment
Containment involves many different disciplines, concepts, and technologies to protect the product, people, facility, and environment. One of the objectives of this Guide is to consolidate this knowledge into one document that describes and discusses the methodologies, processes, and technologies commonly used in the pharmaceutical industry.
Published: November 2022
APQ Guide: Cultural Excellence
Cultural excellence is fundamental to the delivery of sustained quality and performance improvement. It acts as the foundation for the PQS elements described in ICH Q10. The ISPE APQ Guide: Cultural Excellence provides a systematic approach to assessing and advancing an organization’s culture of quality.
Published: September 2022
APQ Guide: Process Performance and Product Quality Monitoring System
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.
Published: July 2022
GAMP® 5 (Second 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.
Published: May 2022
Good Practice Guide: Membrane-Based Water for Injection Systems
Membrane-based based technologies for producing WFI have been in existence for over 20 years but have only recently been widely accepted around the globe. The recent acceptance of these technologies by the European Pharmacopoeia along with most other pharmacopeias has served as the driving force behind this Guide.
Published: March 2022
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 requirements for each system to function as part of an integrated process train.
Published: February 2022
APQ Guide: Change Management 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.
Published: December 2021
Good Practice Guide: Controlled Temperature Chambers 2nd Edition
The Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance. The most significant changes are:
Published: November 2021
Guide: ATMPs - Autologous Cell Therapy
Advanced Therapy Medicinal Product (ATMP) therapies include cells, engineered tissues, or the manipulation of the patient’s genome. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals).