ISPE has released a new guidance document titled GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach.
The guide uses a complete life-cycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. The guide collects and integrates information and knowledge from many disciplines and sources into a single, comprehensive resource.
The GAMP Good Practice Guide: Manufacturing Execution Systems is one in a series of GAMP Good Practice Guides, which help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency and cost reductions.
The main body of the guide covers an approach to achieving control and compliance, project phase, and the operation phase. Appendices in the guide cover a range of MES topics including coordination of compliance, project and operations activities; planning, domain approach and developing an implementation strategy; system selection; system integration; human and workflow considerations; compliant WIP materials management; configuration management; and standards and models.
A one-day seminar, GAMP Good Practice Guide: Manufacturing Execution Systems — Guide Launch, will be held at the ISPE 2010 Washington Conference on June 8 in Washington, D.C. In addition to receiving a free copy of the guide, attendees will learn how a company can apply a functional strategy to specify, verify and manage all relevant system/application capabilities through the ISA hierarchy instead of a single-application approach.