Good Practice Guides

This revision is a comprehensive guide to pharmaceutical utility sampling, addressing the complexities of collecting representative samples from water, steam, compressed air, and process gases, outlining the differences of sampling for “process control” as opposed to sampling for “quality control”. This Guide applies to manufacturers of pharmaceuticals, medical devices, biologics, cosmetics, and related products as well as equipment manufacturers and vendors.

The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.

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.

This Guide addresses pharmaceutical water and steam systems C&Q by both science and risk-based as well as traditional approaches to increase understanding of GMP water and steam systems in the pharmaceutical and biopharmaceutical industries. It is intended to assist in the integration of the capital project management process, the C&Q process, best practices for defining the PQ approach and the ongoing operation into the Quality Risk Management (QRM) validation lifecycle.

The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain.

This Guide considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. However, the transition from traditional, paper-based validation to a digitally integrated framework remains a complex challenge.

As in previous editions, this Guide provides principles and standardized methodologies for evaluating the containment capability of equipment used in the pharmaceutical industry under specific, defined conditions. The methodologies include sampling and analysis for airborne emissions and surface deposition of surrogate material processed within the equipment following defined test protocols. These methodologies reflect pragmatic good industrial/occupational hygiene practice. The Guide has been revised to include complex equipment systems, such as continuous manufacturing equipment and processes, and additional information on surrogate selection. The analysis and interpretation of data has been expanded, along with new test protocols and updates to existing ones.