Guidance Documents

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: 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

Published: October 2020 Pages: 176 Table of Contents Special Pricing for Emerging Economies Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation

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: August 2007 Pages: 92 Table of Contents Special Pricing for Emerging Economies With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased

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

The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.