Guidance Documents

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.

The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design and use of pharmaceutical ozone sanitization systems, and is the first industry Guidance Document to take a holistic view of these issues.

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.

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.

Published: October 2018 Pages: 196 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated

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.

The Guide is designed to provide a valuable tool for the development of in-house training sessions for advanced training, building on the topics covered in the earlier Introductory US Clinical Trial Materials Training Guide. It may be used in a classroom setting and then by attendees to gain a more in-depth knowledge and as reference source for future use.

Published: February 2011 Pages: 196 Table of Contents Special Pricing for Emerging Economies The GAMP ® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP ® Good Practice Guide: Validation of Process

Published: February 2010 Pages: 144 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the

Published: February 2017 Pages: 164 Table of Contents Special Pricing for Emerging Economies As organizations find themselves operating from multiple sites worldwide, with groups and departments split between multiple geographies, or even using third