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 latest Guides published.


ISPE Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Published: December 2021

ISPE 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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Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Published: May 2021

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

The ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry discusses how KM can enable a more effective PQS. The first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with QRM to enable better risk-based decisions, and shows how KM can enhance nearly every element of the PQS across the product lifecycle.

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Good Practice Guide: Maintenance 2nd Edition

Published: January 2021 

Good Practice Guide: Maintenance 2nd Edition

Since the first edition of this Guide, the ICH Q9 risk-based approach has been widely adopted worldwide. This edition reflects alignment with the risk-based approach with respect to maintenance and the pharmaceutical industry as a whole. Updates to this edition include consolidating basic and good practice categories, adding clarification on terminology for users, and updating examples.

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