Guides

This Guide serves as a valuable resource for both new facilities and the modernization or expansion of existing operations. It was developed by global industry experts and written for facility owners, process engineers, project managers, quality professionals, architects, engineering and construction teams, equipment suppliers, and regulatory specialists. This comprehensive resource provides practical guidance for GMP facility design, process integration, contamination control, risk management, scale-up, sustainability, and regulatory compliance and is an essential reference for organizations supporting the next generation of therapeutic manufacturing.

The revised ICH Q9(R1) has redefined expectations for Quality Risk Management, and this new ISPE Guide will show how to apply these principles and tools. Grounded in regulatory guidance and industry experience, this Guide supports more effective QRM, a stronger Pharmaceutical Quality System (PQS) and improved product availability for patients.

The ISPE Guide: ATMPs – Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle provides an in-depth analysis of validation activities, including analytical methods, equipment, processes, cleaning, and supply chain. It covers how to identify, assess, and mitigate risks unique to ATMPs, enabling implementation of risk-based validation strategies.

This ISPE Sustainability Guide is a foundational document that presents key principles and concepts to reinforce sustainable practices in the pharmaceutical industry, based on global and local guides, including existing regulations. Although intended for Small and Medium Sized Entreprises (SME) at the start of their sustainability journey, larger organizations may also use this Guide to support their sustainability strategy.

The ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies provides an overview of FDA regulations and guidance necessary for conducting safe compounding to help pharmacies understand the requirements of FD&C Act Section 503A. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA.

This Guide focuses primarily on allogeneic cell therapies, specifically manufacturing facility development and design. Allogeneic cell therapies have unique challenges due to the small manufacturing scale, limitations in scale-up, the need to manufacture multiple lots of products concurrently, and the need for flexibility to accommodate a varied and evolving product portfolio. This Guide covers common challenges with allogeneic cell therapy facilities, design concepts specific to allogeneic cell therapy facilities, and GMP layout and architectural design development. Key aspects of the allogeneic cell therapy manufacturing process, including sampling, QC, and process understanding, are presented.

The ISPE Guide: ATMPs - Recombinant AAV Comparability and Lifecycle Management considers requirements and guidance for recombinant Adeno-Associated Virus (rAAV) manufacturing and comparability from the US FDA, EU EudraLex Volume 4 Part IV, EMA Q&A, and ICH Q5E. Drawing on a team of industry experts with global experience, the Guide provides current understanding and best practices on rAAV comparability exercises, offering manufacturers a standardized approach for developing process and product comparability strategies. It provides considerations for evaluating rAAV vector products comparability pre and post-change to the manufacturing process and proposes strategies to address the unique challenges posed by this new class of products.

The ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities aims to help facilities understand the FD&C Act Section 503B requirements. This ISPE Guide combines FDA regulations and recommendations with pharmaceutical industry standards, providing a go-to document for any size 503B facility. The compounding process is covered, from the importance of CGMPs to establishing a Quality system (including qualifying suppliers and vendors), receipt of raw materials/active ingredients, and shipping of the finished drug product.

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). ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest.

The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.