Good Practice Guides

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.

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 Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations describes processes for applying a Unique Identifier (UID) on each primary parenteral container. The Guide outlines best practices for developing, implementing, and managing a traceability project across one or more processes.

The ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. This edition is aligned with the latest regulatory guidance, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, and the FDA draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP.