Guidance Documents

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.

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).

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

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: May 2012 Pages: 104 Table of Contents Special Pricing for Emerging Economies The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) has been updated to address a broader

Published: January 2010 Pages: 216 Table of Contents Special Pricing for Emerging Economies During the operational life of a GxP system, regulators usually focus on the integrity, consistency, and completeness of controls required to maintain