Guidance Documents

Whether you are exploring continuous biomanufacturing (CBM) for the first time or optimizing an existing platform, this new Guide provides the insights needed to stay ahead. It covers everything from regulatory considerations and lifecycle management to the integration of future technologies that are redefining the future of drug substance manufacturing. This Guide is about enabling smarter, faster, and more flexible manufacturing, without compromising on safety or quality. It is a roadmap for those ready to lead the next wave of innovation in biomanufacturing operations.

This Guide provides a comprehensive framework and set of good practices to support holistic digital enablement in Pharma 4.0™. It is geared toward a wide range of stakeholders involved in the digital transformation journey, offering insights into best practices for aligning and optimizing digital initiatives in a flexible, scalable approach.

This Guide delivers practical, expert-driven insights into the selection and qualification of equipment for cellular therapy manufacturing. Focused on autologous and allogeneic therapies, it addresses key challenges in aseptic processing, automation, and scalability. Aligned with global regulatory standards, it supports both manufacturers and vendors in advancing closed, automated, and cost-effective solutions that improve patient outcomes.

Continuous manufacturing (CM) for oral solid dosages (OSD) is growing but the rate of adoption has been slowed down by infrastructure and cross-functional challenges. This Guide offers practical strategies for CM control, covering process modeling, spectroscopy, sampling, statistics, and regulations. It aims to streamline implementation, support lifecycle management, and encourage industry adoption by removing barriers during development and enhancing commercialization success.

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.

Technological innovations in Artificial Intelligence (AI) provide new opportunities for the life sciences, and offer new ways to approach challenges in GxP regulated processes. While such approaches offer promising advancements, additional responsibilities are also introduced that require thoughtful decision-making to ensure effective use of emerging technology.

This ISPE GAMP® Guide: Artificial Intelligence is the single source for a holistic interpretation on effectively developing and using AI-enabled computerized systems in GxP areas, while safeguarding patient safety, product quality, and data integrity. It reviews existing guidance and expectations on good practices and presents additional concepts for areas not covered by guidance. Offering a robust, cost-effective approach when applied with expertise and good judgement, the framework presented in this Guide helps to ensure that AI-enabled computerized systems are of high-quality, effective, fit for their intended use, and compliant with applicable regulations. Key principles and practices relevant to the design, development, operation, and use of AI are also discussed.

This updated Guide offers comprehensive guidance on designing and operating pharmaceutical water storage and distribution systems that utilize ozone for sanitization. It outlines key principles for implementing an effective sanitization approach. Using ozone as the primary sanitizing agent in a pharmaceutical water distribution system offers a wide range of operating and cost advantages. Their significance varies depending upon the site and project. Like all sanitization methods, ozone technology imposes specific requirements on system design and operation.

This Guide aims to clarify GMP HVAC issues that are critical to the safety, identity, strength, purity, and quality of pharmaceuticals, biopharmaceuticals, advanced therapy medicinal products, and medical devices, from raw materials to finished products. It covers HVAC control and monitoring requirements and addresses GEP issues related to sustainability, economics, and environmental health and safety. The Guide provides best practices for implementing international regulatory and industry guidance, with appendices containing industry examples and templates for the reader’s reference.

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.