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.
Published: April 2024
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.
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.
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.
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.
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.
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.
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.