Coming Soon & Recently Published Guidance Documents

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.

GAMP® 5 (Second Edition) Guide

Coming Soon: 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. 

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Good Practice Guide: Membrane-Based Water for Injection Systems

Coming Soon: 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.

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms (Bound)

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. 

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Guide: Change Management System

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.

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ISPE Good Practice Guide: Controlled Temperature Chambers 2nd Edition

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:

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Guide: ATMPs - Autologous Cell Therapy

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). 

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Good Practice Guide: Good Engineering Practice 2nd Edition

Published: October 2021

Good Practice Guide: Good Engineering Practice 2nd Edition

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement.

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GAMP Good Practice Guide: Enabling Innovation

Published: September 2021

GAMP Good Practice Guide: Enabling Innovation

The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management provides information to support the adoption of new and improved approaches to software engineering, data management, and “as a Service” offerings (XaaS), including the use of supporting tools. 

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Good Practice Guide: IMP Reverse Logistics

Published: August 2021

Good Practice Guide: IMP Reverse Logistics

The pharmaceutical industry has developed standards and best practices in almost every aspect of a trial. There is, however, one area that lacks foundational best practices: that of medicinal product accountability, reconciliation, and return for destruction, otherwise known as reverse logistics.

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APQ Guide: Management Responsibilities & Review (MRR)

Published: July 2021

APQ Guide: Management Responsibilities & Review (MRR)

ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. 

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