"It's a major revision, and it is aimed at enabling innovation and pragmatic, cost-effective compliance," says Sion Wyn, the guide's editor. The guide addresses the entire lifecycle of an automated system and its applicability to information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end-user applications, and patch management, says ISPE. The guide is available to association members for US$250/£185. The cost for nonmembers is US$450/£375. [HCP]
ISPE launches GAMP 5
The International Society for Pharmaceutical Engineering (www.ispe.org) introduced "GAMP 5: A Risk-Based Approach to Compliant GXP Computerized Systems." A new innovation with GAMP 5 is an accompanying CD that provides supporting materials, including information on the differences between GAMP 5 and its predecessor, GAMP 4.
Apr 15, 2008
"It's a major revision, and it is aimed at enabling innovation and pragmatic, cost-effective compliance," says Sion Wyn, the guide's editor. The guide addresses the entire lifecycle of an automated system and its applicability to information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end-user applications, and patch management, says ISPE. The guide is available to association members for US$250/£185. The cost for nonmembers is US$450/£375. [HCP]
See What’s Possible in Life Sciences Packaging at PACK EXPO International
Explore new machinery & materials from 2,600 exhibitors. Gain insights from 150+ free educational sessions. Find solutions to tackle the toughest challenges—for life sciences & beyond—at North America’s largest packaging & processing event.
REGISTER NOW & SAVE
Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Downloads
