Posts Tagged ‘critical quality attributes’

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
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It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]

Is Process Analytical Technology Rocket Science?

Posted in Life Sciences on Thursday, January 21st, 2016. No comments yet
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More than a decade ago, the U.S. Food and Drug Administration published, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. In this document, the FDA explained: The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, is intended to support innovation and efficiency in pharmaceutical […]

Clarifying Design Space, Process Analytical Technology and Quality by Design

Posted in Life Sciences on Wednesday, March 11th, 2015. No comments yet
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For pharmaceutical and biopharmaceutical manufacturers, there are a lot confusion around the concepts of design space (DS), Process Analytical Technology (PAT), and Quality by Design (QbD). Emerson’s Zuwei Jin believes that this confusion has largely limited the opportunities where PAT may be implemented, since many of these decisions need to be made early, such as […]

Continued Process Verification in the Process Validation Lifecycle

Posted in Life Sciences, Operations Management on Thursday, January 22nd, 2015. 5 comments so far
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In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices. It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems […]

Enabling Release by Exception Manufacturing

Posted in Emerson Exchange, Life Sciences on Thursday, September 11th, 2014. 2 comments so far
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The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson’s Michalle Adkins who mentioned that her team of Life Sciences consultants would be highlighting the enablement of release by exception. Although release by exception and real-time release are not yet a reality for the majority of pharmaceutical […]