Reflecting current regulatory expectations and best practices, Good Practice Guides (GPGs) help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.
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.
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.
The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases was created for users of water, steam, compressed air or process gases and impacts facilities, production, and quality control personnel within a facility.
The ISPE Good Practice Guide on the Management of Engineering Standards aims to provide a common understanding and approach to the management of Engineering Standards. It is based on industry best practices and developed with input from several peer organizations. The Guide addresses the knowledge management needs associated with the identification of content, creation, review, and approval of Engineering Standards.
Published: March 2014 Pages: 118 Table of Contents Appendix 2 Special Pricing for Emerging Economies Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for
Published: November 2011 Pages: 92 Table of Contents Special Pricing for Emerging Economies Interactive response technology is a tool that can be used to support multiple business processes and this Guide describes how the pharmaceutical industry can
