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.

Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies

Coming Soon

Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies

Struggling to understand 503A compounding regulations? This Guide is your go-to resource for compounding sterile and nonsterile preparations. Combining information from multiple USP chapters with industry good practices, this ISPE Guide provides the reader with the tools for implementing safe compounding practices.

 

Guide: ATMPs - Allogeneic Cell Therapy

Published: January 2024

Guide: ATMPs - Allogeneic Cell Therapy

The development, regulatory path, facility design, qualification, and manufacture of ATMPs present significant challenges to manufacturers, engineers, and suppliers. The GMP regulations are evolving as novel processes are presented and manufacturing paradigms are being tested. This Guide addresses facility engineering issues that are most applicable at the time of publication, as based on the experience of the authors.

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Published: January 2024

Guide: ATMPs - rAAV Comparability & Lifecycle Management

The ICH Q5E principles for demonstrating comparability of biological products are not fit for purpose for ATMPs, resulting in different approaches across the industry. The ISPE Guide: ATMPs - Recombinant AAV Comparability and Lifecycle Management provides current understanding and best practices on rAAV comparability exercises, offering manufacturers a standardized approach for developing process and product comparability strategies.

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Baseline Guide Volume 8: Pharma 4.0™ (First Edition)

Published: December 2023

Baseline Guide Volume 8: Pharma 4.0™ (First Edition)

Questions on starting or re-starting your digital transformation? We’ve got answers. Digital transformation stalled? Deciding where to start your transformation journey? We can help. Research shows that 70% of digital transformations fall short of their objectives. We can help you turn that around.

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Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Third Edition)

Published: November 2023

Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Third Edition)

This Guide presents concepts that reflect how these changes affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.

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Good Practice Guide: Process Gases (Second Edition)

Published: October 2023

Good Practice Guide: Process Gases (Second Edition)

Presenting recent advances in construction materials and updates on current good practices, this edition is aligned with the latest guidance, such as the newly revised Annex 1 and the ISPE Baseline® Guide: C&Q (Second Edition). Topics discussed include contaminant reduction, sustainability requirements, and medical gases regulations.

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Guide: 503B Compounding – Regulatory Basis & Industry Good Practices for Outsourcing Facilities

Published: August 2023

Guide: 503B Compounding – Regulatory Basis & Industry Good Practices for Outsourcing Facilities

Struggling to understand 503B outsourcing facilities regulations? This Guide is your go-to resource for practical guidance on aseptic practices and facilities appropriate for your scale of manufacturing. Combining information from applicable regulations and guidances with industry good practices, this ISPE Guide provides the reader with the tools and rationale for implementing effective processes.

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