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.
"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]
