Good Practice Guides

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.

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

The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment including background to safe working levels and the mechanisms of exposure and how such exposure can be controlled. There are chapters on typically applied approaches used in containing exposure for commonly applied process systems across all elements of pharmaceutical development and manufacturing.

The Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance. The most significant changes are:

Every year the number of clinical trials conducted across the globe rises in a concerted effort to develop new or improved medicinal products that ultimately improve lives. The pharmaceutical industry has developed standards and best practices in almost every aspect of a trial. There is, however, one area that lacks foundational best practices: that of medicinal product accountability, reconciliation, and return for destruction, otherwise known as reverse logistics.

Published: March 2013 Pages: 42 Table of Contents Special Pricing for Emerging Economies The pharmaceutical industry has been using fan-folded labels or booklet labels for many years, providing greater efficiency in production and reducing the cost

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.

Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.

The ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications.

The ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system.