Interphex 2003: automation highlights pharmaceutical congress
New York, NY—Thousands of innovative solutions and useful products were viewed by thousands more attendees at the International Pharmaceutical Industry Congress (IPIC), March 31-April 2, at the Jacob K. Javits Convention Center. IPIC gave attendees a chance to participate in four simultaneous and related shows and conferences, including Interphex.
New York, NY— Thousands of innovative solutions and useful products were viewed by thousands more attendees at the International Pharmaceutical Industry Congress IT Expo and Summit.
Also, daily conference sessions sponsored by the International Society of Pharmaceutical Engi-neers (ISPE, Tampa, FL) were available for a variety of topics including timely FDA related top-ics, such as the U.S. Food and Drug Administration's (FDA, Rockville, MD) 21 CFR Part 11 regulation and newly released guidance document for electronic records and electronic signatures. [See Control Engineering, May 2003, for more information about 21 CFR Part 11 and the use of risk-based implementation guidance.]
The keynote address on April 1, entitled "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," was delivered by the FDA's district director for New Jersey, Douglas Ellsworth, who says it's been 25 years since the FDA updated any of its current good manufacturing practices (cGMPs). He added that the FDA recognizes its current mode of forcing manufactures to adopt a regulatory driven manufacturing improvement attitude stifles development and/or use of innovative technologies, and this new FDA initiative is designed to change that situation.
Also, FDA is undertaking efforts to ensure legal, technical, and scientific consistency is applied in its development of 483 (warning) reports. Ellsworth adds that, "FDA will also be including clarification language in its 483s to help minimize the abuse of how stock analyst and competitors might use 483s to gain competitive advantage."
Innovative products and solutions
Decision Management International (DMI, Bradenton, FL) and Emerson Process Management (Austin, TX) demonstrated an integrated solution designed to reduce product cycle times, realize cost savings, and comply with cGMPs. The solution integrates DMI's Regulus, a zero-client application built on the Microsoft .NET architecture, with Emerson's DeltaV automation system to create a manufacturing environment that enables the enterprise to link its process automation systems with compliance and workflow systems in such a way that helps ensure cGMP compliance. Visit www.dmius.com for more information.
Emerson Process Management's Micro Motion
Everest VIT ical failures. Equipped with its own light source and a digital camera, XL Pro allows users to establish visual records of process system integrity over time. Visit www.everestvit.com for more information.
Rockwell Automation these operations from paper-based to electronic-based systems, the solution helps manufacturers increase production efficiency, improve product consistency and quality, and reduce waste. Rockwell also demonstrated its latest release of Propack Data PMX CTM 3.3.0 en-terprise production management software. This version is designed to meet the demands of the international user group of PMX CTM clients; provide more efficient clinical trial management; and offer improved usability, enhanced quality, and adjusted functionality, including clinical supply planning. This last is a completely new functionality added to this version of the PMX CTM suite.
Schneider Electric t and OneStep Generator programming software to provide secure program and network access, document management, and version and audit trail capability. Schneider adds that this solution is configurable for a broad range of pharmaceutical applications, including packaging, process, and utilities.
Control Engineering Daily News Desk
Dave Harrold, senior editor