Tag Archive | "qbd"

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications


AskAboutValidation.com posted a really great  Quality by Design overview piece in late 2012.

The piece includes:

  • A definition of QbD
  • Bullet point list of the QbD development process
  • Comparison of traditional approaches versus enhanced QbD approaches
  • Understanding of the advantages of QbD

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QbD Implementation in the Generics Industry: Overview and Teva Case Study


As generic pharmaceutical manufacturers work to find the balance between speed, efficiency and product quality excellence, QbD approaches are playing an important role.

Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals, at IFPAC 2013 walked through the merits of QbD in meeting the challenges generic manufacturers face.  He also presented a compelling case study from Teva Pharmaceuticals’ experiences.

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PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality


This presentation delivered by Vibhaker Shah, Ph.D., FDA Senior Policy Advisor, is a great reference resource on the merits of QbD, PAT and their links to the fairly new Process Validation guidance.

Click to view slides

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Do We Need PAT and QbD Anymore?


By Agnes Shanley

The last gasp of winter, 2011, brought  with it record snowfalls and tragic natural disasters, as well as some quiet and unheralded news that, some observers believe, may signal new competitive pressures in store for the drug industry.

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IFPAC Wrapup: Issues in Applying PAT and QbD to Biomanufacturing


By Gary Ritchie

This year’s IFPAC conference, held last week in Baltimore, was a bit different. For one thing, it was clear that miniaturization has brought significant advances to analytical instrumentation. On display were miniature spectrophotometers and biosensors, and miniaturized tissue chambers. Another difference was an emphasis in this year’s program on process and quality tools for use in biopharmaceutical manufacturing.

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QbD: Enabling Process Knowledge Beyond Validation


By Pedro Hernandez, Pharmaceutical Consultant

If drug manufacturing is not to remain an anachronism, more scientific ways must be advanced to improve product quality. Shown here, young Thomas Edison

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