Process and Automation

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The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

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PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

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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.

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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.