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 […]
For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson’s Michalle Adkins who shared these trends with me. She identified six major areas: continuous manufacturing, single use technology, biosimilars & generics, personalized medicine, demographic shifts, and taking […]
A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements. Emerson’s Michalle Adkins played a role in its contents. The whitepaper highlights: …how reliable, accurate instrumentation allows automation to support quality and productivity […]
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 […]
Measuring quality in real-time improves the overall performance of a manufacturing process. The International Foundation Process Analytical Chemistry (IFPAC) is: …a world-wide, not-for-profit organization dedicated to the advancement of Process Analytical Technology and Chemistry. They are holding the IFPAC Annual Meeting later this month in the Washington D.C. area. This meeting provides a forum for […]
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