GAMP® Good Practice Guide: Manufacturing Execution Systems Guide Now Available
(TAMPA, FLORIDA, USA, 08 MARCH 2010) - ISPE , a global not-for-profit association of 24,000 technical professionals working in the manufacturing and drug development sectors of the pharmaceutical industry, has released a new guidance document entitled: GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach .
The new 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 8 June in Washington DC, USA. 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.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 24,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.