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November 01, 2008
FDA advocates building quality into a product through PAT.
October 01, 2008
The biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.
May 02, 2008
Getting IT, engineering, and manufacturing on the same page requires a delicate balance.
Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
ISA 100.11a and WirelessHART both seek to become the global standard for industrial wireless automation.
April 16, 2008
A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.
March 01, 2008
Six sigma, process analytical technology (PAT) and related initiatives are driving greater use of statistical analysis methods to increase process understanding and improve manufacturing capabilities.
February 02, 2008
FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.
October 01, 2007
To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.
Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.