Good Practice Guides

Published: May 2024 Pages: 86 Table of Contents Special Pricing for Emerging Economies Many current challenges facing the pharmaceutical industry revolve around increasing product complexity, reduced batch sizes, and higher flexibility requirements

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for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, and the FDA draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.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: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.

Published: June 2017 Pages: 132 Table of Contents Special Pricing for Emerging Economies Decommissioning is a general term for a process to remove something from active status. It may be a precursor to putting facilities/equipment into storage

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.

Published: September 2009 Pages: 288 Table of Contents Special Pricing for Emerging Economies Heating, Ventilation, and Air Conditioning (HVAC) systems are critical systems that can affect the ability of a pharmaceutical facility to meet its

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM).

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.

For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems for getting work done. The ISPE Good Practice Guide: Operations Management aims to provide the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management.